eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. 

OVERVIEW

The Manager, Quality Systems & Operations (QSO) is responsible for leading the day-to-day operation, governance, and continuous improvement of the organization’s Quality Management System (QMS) within a regulated clinical technology environment. This role serves as the operational backbone (“engine room”) of the Quality & Compliance function and ensures quality processes are efficient, inspection-ready, risk-based, and aligned with the needs of a clinical trial software / technology-enabled services organization.

The Manager, QSO will oversee core quality system processes including document control, SOP lifecycle management, training administration and effectiveness support, quality events and CAPA management, quality metrics and management reporting, and cross-functional process improvement initiatives. This role partners closely with Product, Engineering, Information Security, Operations, Client Services, Audits & Assurance (AA), and Systems & Regulatory Compliance (SRC) to support GxP expectations, customer requirements, and operational excellence.

KEY TASKS & RESPONSIBILITIES

➢ Quality Management System (QMS) Ownership

• Own the administration, maintenance, and continuous improvement of the enterprise QMS supporting a clinical trial software / vendor services environment.
• Manage controlled documentation processes including SOPs, policies, work instructions, templates, validation documentation, and periodic reviews.
• Ensure document control practices meet internal governance, client expectations, and applicable GxP / computerized systems requirements.
• Maintain version control, approvals, archival, training linkage, and retention controls for quality records.

➢ Quality Operations / Day-to-Day Oversight

• Serve as operational lead for daily quality system workflows, requests, escalations, and prioritization.
• Ensure timely execution of quality deliverables including document approvals, event reviews, CAPA follow-up, training assignments, and management reporting.
• Coordinate core quality activities across business and technical functions in a fast-paced SaaS / vendor setting.

➢ Quality Events, Investigations & CAPA

• Oversee quality events including deviations, incidents, customer quality issues, audit observations, system/process nonconformances, and supplier quality concerns as applicable.
• Manage CAPA lifecycle from initiation through closure, including root cause analysis, action tracking, due dates, evidence review, and effectiveness verification.
• Facilitate governance reviews for aging items, repeat issues, overdue actions, and systemic trends.
• Support quality investigations involving validated systems, software releases, data integrity concerns, or service delivery issues.

➢ Training Program Support & Effectiveness

• Support administration of the quality training program and learning compliance processes.
• Ensure role-based training matrices align with regulated responsibilities and controlled procedures.
• Provide guidance on training effectiveness assessments, retraining triggers, and onboarding quality training.
• Monitor completion rates, overdue training, and training-related KPIs.

➢ Metrics, KPIs & Management Reporting

• Develop and maintain enterprise quality dashboards, KPIs, and trend reports.
• Report on QMS health including document control cycle times, CAPA status, training compliance, audit observations, quality events, and recurring risks.
• Use data to identify improvement opportunities and inform management review activities.

➢ Continuous Improvement / Operational Excellence

• Identify opportunities to streamline, automate, and mature quality processes while maintaining compliance.
• Lead initiatives to improve user experience and adoption of quality systems/tools.
• Support implementation, configuration, or enhancement of electronic QMS (eQMS), LMS, issue management, and workflow tools.

➢ Cross-Functional Partnership

• Partner with Product, Engineering, DevOps, Security, and Operations teams to embed practical quality controls into business processes.
• Collaborate with Audits & Assurance (AA) on internal/external audit readiness, observations, and remediation.
• Collaborate with Systems & Regulatory Compliance (SRC) on GxP requirements, supplier/customer obligations, validation governance, and regulatory commitments.
• Support client due diligence requests, quality questionnaires, and customer audits as needed.

➢ Other duties as assigned

Education & Experience

➢ Bachelor’s degree in Life Sciences, Quality, Engineering, Computer Science, Business, or related discipline preferred
➢ 12+ years of experience in Quality Systems, Quality Operations, Compliance, or related roles within a regulated environment preferred
➢ Experience in a clinical trial software vendor, SaaS healthcare technology, CRO, life sciences technology, eClinical, or related GxP-supporting organization
➢ ASQ, Six Sigma, ISO, GxP, or related certifications preferred

Professional Skills

➢ Working knowledge of GxP principles, computerized systems controls, data integrity expectations, and risk-based quality management
➢ Experience supporting customer audits, supplier audits, or regulatory inspections preferred
➢ Experience managing CAPA, investigations, document control, training systems, and quality metrics
➢ Strong communication, organization, and stakeholder management skills
➢ Familiarity with CSV / CSA concepts and validation documentation for regulated systems preferred

Technical Skills

➢ Experience using electronic QMS platforms and workflow systems
➢ Experience with tools such as Qualio, Veeva, MasterControl, TrackWise, Jira, or similar platforms preferred

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!

eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

Role Overview: 

As an Insights/Secondary research - CoE team member, you will partner closely with global consulting teams to deliver high quality secondary research, market insights, and targeted analyses that inform strategic recommendations for our life sciences clients. You will develop a strong foundation in the life sciences industry and exposure to a diverse set of strategic questions across the product lifecycle. The work will span questions related to clinical development, commercialization, pricing and market access, launch planning, corporate and investor strategy, diagnostics, and new product planning.

Key Responsibilities:

• Conduct targeted secondary research on diseases, therapies, competitors, clinical pipelines, and market dynamics using public and proprietary data sources (e.g., EvaluatePharma, GlobalData, Navlin, MMIT, AnswerSuite, company filings, HTA portals).
• Synthesize research findings into clear, structured, and slide‑ready deliverables, including market landscapes, analytical frameworks, and concise written insights.
• Develop disease, assets, and company overviews; treatment algorithms; guideline and standard of care maps; and epidemiology driven market context summaries to support a broad range of strategic work.
• Perform analog research and benchmarking across launch, uptake, access, pricing, evidence generation, and go‑to‑market strategies to inform strategic decision‑making
• Summarize HTA, payer, and reimbursement decisions, identifying key value messages, evidence expectations, pricing and access outcomes, and drivers of payer decisions across markets.
• Prepare structured competitor and payer relevant profiles, including strategy, evidence, positioning, and deal or funding activity, to support both project and internal business development needs.
• Build and maintain reusable research assets, including competitive landscapes, analog libraries, launch timelines, and technology and policy trend trackers.
• Support qualitative research efforts by helping prepare discussion guides, synthesizing interview notes, and organizing insights for hypothesis testing.
• Work with global consulting colleagues to clarify problem statements, refine research questions, and iteratively improve output based on feedback.
• Contribute to the creation of templated outputs that integrate research insights into overall project deliverables (e.g., storyline aligned slides, appendices, and supporting materials).
• Ensure quality and consistency of research outputs by adhering to internal standards, referencing guidelines, and formatting best practices.
• Participate in internal knowledge building initiatives, including upkeep of internal knowledge repositories, templates, and best practice examples.

Qualifications & Requirements:

• 4-6 years of experience in life sciences consulting, market research, competitive intelligence, HTA / HEOR support, or similar insights focused roles.
• Undergraduate or master’s degree in a life science discipline (e.g., biology, biochemistry, pharmacology, biotechnology, pharmacy) or related field.
• Demonstrated interest in the global biopharmaceutical industry and strategic questions related to R&D, commercialization, pricing & access, launch and lifecycle management, diagnostics, and corporate / investor strategy.
• Ability to independently execute well-scoped research workstreams (e.g., literature scans, competitive profiles, basic epidemiology/market sizing desk research) with moderate oversight.
• High attention to detail in referencing, data checking, and ensuring consistency of narratives and exhibits across multiple sources.
• Strong written and verbal communication skills in English, with the ability to translate complex scientific and commercial concepts into accessible, actionable insights.
• Highly analytical and structured approach to organizing information and building logical narratives from evidence.
• Enthusiasm for collaborating with distributed global teams and comfort working across time zones.
• Strong proficiency in Microsoft PowerPoint and Excel; familiarity with common life science data and literature sources (e.g., clinical trial registries, scientific literature, company reports, analyst reports) is a plus.
• Ability to work in a hybrid setup, with 3 days per week from the Gurgaon office.

Position Summary:

The Procurement Manager is responsible for managing an efficient and effective procurement operation for acquiring materials, supplies, equipment, and services in connection with the delivery of services supporting clinical trials. The Procurement Manager is responsible for organizing and supervising procurement activities that include but are not limited to: (i) managing and tracking the request for proposal (RFP) lifecycle; (ii) negotiating preferential pricing; (iii) establishing and tracking towards savings targets; and (iv) performing other commercial and transactional activities.

Essential functions of the job include but are not limited to:

• Developing and implementing procurement strategies that align with the company’s objectives.
• Managing the solicitation process, including reviewing/comparing specifications and costs and where appropriate supporting negotiation with vendors to reduce costs.
• Negotiating terms and conditions with suppliers to ensure the best possible prices and agreements.
• Developing tools and processes to support efficient and quality driven procurement activities.
• Maintaining an up-to-date knowledge of the industry’s market trends and developments.
• Leading transformational activities to build organizational procurement capabilities and improve procurement efficiency.
• Delivering value and competitive advantage measured by cost reduction and cost avoidance, vendor-enabled innovation, and risk mitigation.
• Ensuring compliance in purchasing process, especially in vendor selection and bidding.

Minimum Required:

• Bachelor’s degree in business administration, accounting, economics, or related field required or International equivalent education.
• Minimum of five years of work experience in life science procurement and outsourcing.

Other Required:

• Excellent communication and negotiation skills
• Proficiency in Microsoft Office Applications (Excel, Word, etc.).
• Knowledge of purchasing policies processes, and procedures.
• Knowledge and ability to negotiate best vendor terms and pricing.
• Experience with clinical trial procurement and contract research organization operations.
• Procurement and Supply Chain Certifications
• Experience managing and developing staff.

Skills:

• Strong negotiation and interpersonal skills.
• Excellent analytical, decision-making, and management skills.
• Capability to work under pressure and adapt to dynamic environments.
• Attention to detail and a commitment to achieving operational efficiency.

Position Summary:

The Procurement Manager is responsible for managing an efficient and effective procurement operation for acquiring materials, supplies, equipment, and services in connection with the delivery of services supporting clinical trials. The Procurement Manager is responsible for organizing and supervising procurement activities that include but are not limited to: (i) managing and tracking the request for proposal (RFP) lifecycle; (ii) negotiating preferential pricing; (iii) establishing and tracking towards savings targets; and (iv) performing other commercial and transactional activities.

Essential functions of the job include but are not limited to:

• Developing and implementing procurement strategies that align with the company’s objectives.
• Managing the solicitation process, including reviewing/comparing specifications and costs and where appropriate supporting negotiation with vendors to reduce costs.
• Negotiating terms and conditions with suppliers to ensure the best possible prices and agreements.
• Developing tools and processes to support efficient and quality driven procurement activities.
• Maintaining an up-to-date knowledge of the industry’s market trends and developments.
• Leading transformational activities to build organizational procurement capabilities and improve procurement efficiency.
• Delivering value and competitive advantage measured by cost reduction and cost avoidance, vendor-enabled innovation, and risk mitigation.
• Ensuring compliance in purchasing process, especially in vendor selection and bidding.

Minimum Required:

• Bachelor’s degree in business administration, accounting, economics, or related field required or International equivalent education.
• Minimum of five years of work experience in life science procurement and outsourcing.

Other Required:

• Excellent communication and negotiation skills
• Proficiency in Microsoft Office Applications (Excel, Word, etc.).
• Knowledge of purchasing policies processes, and procedures.
• Knowledge and ability to negotiate best vendor terms and pricing.
• Experience with clinical trial procurement and contract research organization operations.
• Procurement and Supply Chain Certifications
• Experience managing and developing staff.

Skills:

• Strong negotiation and interpersonal skills.
• Excellent analytical, decision-making, and management skills.
• Capability to work under pressure and adapt to dynamic environments.
• Attention to detail and a commitment to achieving operational efficiency.

Position Summary: 

Precision AQ’s Product Solutions team is expanding in India.  Our focus is building and delivering products and productized services spanning oncology access, social/digital listening, and clinical trial document analysis.  Working with an established India based engineering/research team and global product managers/product owners, the Product Owner will leverage their experience to bring new capabilities and products to market.   This is a hybrid role having both project management/business analysis (established products) and product management (AI-powered offering) responsibilities.  The Product Owner is a critical role to ensure workload balance across the engineering team while effectively managing timelines.

The Product Owner’s primary responsibility is ownership of the project backlogs in Azure DevOps (ADO).  Ownership includes leading feature/user story grooming, sprint planning, and testing coordination.  They will identify risks to project development and escalate to stakeholders when appropriate.  The ideal candidate is experienced leveraging standard frameworks (Scrum) and modifying to fit the culture of the team and the organization.  

The Product Owner will also serve as the product owner for a new, AI-Powered offering.  This offering combines subject matter experts with AI/ML, Quality and infrastructure engineering to deliver a productized service.  In their role as product owner, they will translate requirements from the subject matter expert and combine with strategy driven by the product manager to build a product backlog.

The successful candidate thrives in fast paced environments and is comfortable speaking up as a trusted partner for the other product owners and product manager.  Strong attention to detail, the ability to find solutions to complex resource constraint challenges, and a positive attitude are critical skills for the Product Owner.

Essential functions of the job include but are not limited to: (This is NOT meant to be an exhaustive task list)

1. Project Management & Workflow Management

• Manage product and project backlogs for multiple SaaS/internal products including Epics, Feature, User Stories, Bugs, and tasks
• Ensure consistent intake, triage, tagging, prioritization, and assignment of all product and engineering work items.
• Partner with Product, Engineering, and Research to ensure stories are clear, testable, and aligned to product goals.
• Track sprint progress, dependencies, blockers, and delivery milestones; escalate risks proactively.
• Build dashboards and reporting views for leadership on throughput, velocity, backlog health, and cycle time.

1. Product & Requirements Support

• Collaborate with Product Manager and Product Owners to translate business needs into structured, well defined features, user stories with acceptance criteria.
• Support grooming, sprint planning, and cross functional alignment on requirements.
• Ensure documentation across products remains organized, version controlled, and easily accessible.
• Maintain crosswalks between project management items and client commitments, internal deliverables, and operational processes.

1. Analytics & Data Operations Coordination

• Coordinate product operations tasks (e.g., dataset refreshes, quality checks, dashboard updates).
• Partner with data engineering and QA to ensure data pipelines are represented correctly within project workflows.
• Track testing cycles, defects, validations, and signoffs for new data processes and product features.

1. Process Improvement & Standardization

• Identify bottlenecks in product and data workflows; propose and implement scalable solutions.
• Improve consistency in story writing, sprint hygiene, testing documentation, and release processes.
• Help drive automation and efficiency initiatives across OG and KDS workflows (aligned with PS strategic themes)

Qualifications:

BA Degree in Computer Science, Software Engineering, Operations Engineering, Business Management or other related field

Minimum Required:

• Minimum 5 years’ experience in SAFe/Agile organization in the role of Sr Business Analyst, Product Owner, Project Manager, or related role
• Handson experience with Azure DevOps (mandatory).
• Knowledgeable in software development and other relevant web technologies
• Ability to write clear user stories, requirements, and acceptance criteria.
• Strong organizational and communication skills.
• Experience collaborating with Engineering, Data, and Product teams.
• Comfort working with analytics and datadriven workflows.

Preferred:

• Experience in healthcare analytics, oncology, market access, or life sciences data.
• Experience managing development of AI-enabled solutions
• Experience with product management software systems
• Experience with Scaled Agile Framework for Product Management
• Product Owner Certifications, such as:
• Certified Scrum Product Owner (CSPO) or willingness to certify
• Professional Scrum Product Owner (PSPO)
• SAFe Product Owner
• PMI Agile Certified Practitioner (PMI-ACP)
• EXIN Agile Scrum Product Owner
• Understanding of design quality standards
• Experience managing sprint ceremonies or operational delivery cadences.
• Ability to understand complex datasets and translate them into structured work items.

Competencies:

• Communication Skills: Written, Verbal, and Presentation: The successful candidate must have the ability to read, analyze, and interpret production data, financial reports, and legal documents. Excellent verbal, written, presentation, interpersonal skills including ability to clearly respond to common inquiries or complaints from customers, employees, and members of the business community. Must possess a rapid agility to reply to emails, provide instructions of work stream necessities or issues encountered, business and report writings in a succinct and informative manner.
• Business Judgment and Strategic Thinking: Ability to think, act, and deliver value in the best interest of our clients with respect to common practices of the healthcare consulting field. Ability to extrapolate from the specific to the general and interpret from the general to the specific.
• Analytic Skills: Framing macro problems into action steps or work plans for resolutions. Structuring a persuasive client presentation based on in-depth or expansive excel spreadsheets. Demonstrable interpretive and solution identification skills with the ability to understand multiple types of quantitative and qualitative data heightened with strong resolution skills.
• Collaboration and Teamwork: Ability to give and receive constructive feedback and work effectively across the organization to accomplish team goals is critical. The successful candidate must possess excellent judgment, management, and conflict resolution skills. Ability to work with team members to convey results, incorporate enhancements and productionize processes across projects. Must be able to understand the dynamics of how a team interconnects and relies upon every member.
• Strategic Thinking: Conceptualize outside of the aspects of a project at hand, with an ability to visualize how the work contributes to and drives forward the overall project.
• Solutions oriented: must be able to display resourcefulness and confidence under pressure
• Resilience: must be able to look past obstacles and roadblocks, ask questions and for support, and find their way around any obstacle.

Position Summary: 

Precision AQ’s Product Solutions team is expanding in India.  Our focus is building and delivering products and productized services spanning oncology access, social/digital listening, and clinical trial document analysis.  Working with an established India based engineering/research team and global product managers/product owners, the Product Owner will leverage their experience to bring new capabilities and products to market.   This is a hybrid role having both project management/business analysis (established products) and product management (AI-powered offering) responsibilities.  The Product Owner is a critical role to ensure workload balance across the engineering team while effectively managing timelines.

The Product Owner’s primary responsibility is ownership of the project backlogs in Azure DevOps (ADO).  Ownership includes leading feature/user story grooming, sprint planning, and testing coordination.  They will identify risks to project development and escalate to stakeholders when appropriate.  The ideal candidate is experienced leveraging standard frameworks (Scrum) and modifying to fit the culture of the team and the organization.  

The Product Owner will also serve as the product owner for a new, AI-Powered offering.  This offering combines subject matter experts with AI/ML, Quality and infrastructure engineering to deliver a productized service.  In their role as product owner, they will translate requirements from the subject matter expert and combine with strategy driven by the product manager to build a product backlog.

The successful candidate thrives in fast paced environments and is comfortable speaking up as a trusted partner for the other product owners and product manager.  Strong attention to detail, the ability to find solutions to complex resource constraint challenges, and a positive attitude are critical skills for the Product Owner.

Essential functions of the job include but are not limited to: (This is NOT meant to be an exhaustive task list)

1. Project Management & Workflow Management

• Manage product and project backlogs for multiple SaaS/internal products including Epics, Feature, User Stories, Bugs, and tasks
• Ensure consistent intake, triage, tagging, prioritization, and assignment of all product and engineering work items.
• Partner with Product, Engineering, and Research to ensure stories are clear, testable, and aligned to product goals.
• Track sprint progress, dependencies, blockers, and delivery milestones; escalate risks proactively.
• Build dashboards and reporting views for leadership on throughput, velocity, backlog health, and cycle time.

1. Product & Requirements Support

• Collaborate with Product Manager and Product Owners to translate business needs into structured, well defined features, user stories with acceptance criteria.
• Support grooming, sprint planning, and cross functional alignment on requirements.
• Ensure documentation across products remains organized, version controlled, and easily accessible.
• Maintain crosswalks between project management items and client commitments, internal deliverables, and operational processes.

1. Analytics & Data Operations Coordination

• Coordinate product operations tasks (e.g., dataset refreshes, quality checks, dashboard updates).
• Partner with data engineering and QA to ensure data pipelines are represented correctly within project workflows.
• Track testing cycles, defects, validations, and signoffs for new data processes and product features.

1. Process Improvement & Standardization

• Identify bottlenecks in product and data workflows; propose and implement scalable solutions.
• Improve consistency in story writing, sprint hygiene, testing documentation, and release processes.
• Help drive automation and efficiency initiatives across OG and KDS workflows (aligned with PS strategic themes)

Qualifications:

BA Degree in Computer Science, Software Engineering, Operations Engineering, Business Management or other related field

Minimum Required:

• Minimum 5 years’ experience in SAFe/Agile organization in the role of Sr Business Analyst, Product Owner, Project Manager, or related role
• Handson experience with Azure DevOps (mandatory).
• Knowledgeable in software development and other relevant web technologies
• Ability to write clear user stories, requirements, and acceptance criteria.
• Strong organizational and communication skills.
• Experience collaborating with Engineering, Data, and Product teams.
• Comfort working with analytics and datadriven workflows.

Preferred:

• Experience in healthcare analytics, oncology, market access, or life sciences data.
• Experience managing development of AI-enabled solutions
• Experience with product management software systems
• Experience with Scaled Agile Framework for Product Management
• Product Owner Certifications, such as:
• Certified Scrum Product Owner (CSPO) or willingness to certify
• Professional Scrum Product Owner (PSPO)
• SAFe Product Owner
• PMI Agile Certified Practitioner (PMI-ACP)
• EXIN Agile Scrum Product Owner
• Understanding of design quality standards
• Experience managing sprint ceremonies or operational delivery cadences.
• Ability to understand complex datasets and translate them into structured work items.

Competencies:

• Communication Skills: Written, Verbal, and Presentation: The successful candidate must have the ability to read, analyze, and interpret production data, financial reports, and legal documents. Excellent verbal, written, presentation, interpersonal skills including ability to clearly respond to common inquiries or complaints from customers, employees, and members of the business community. Must possess a rapid agility to reply to emails, provide instructions of work stream necessities or issues encountered, business and report writings in a succinct and informative manner.
• Business Judgment and Strategic Thinking: Ability to think, act, and deliver value in the best interest of our clients with respect to common practices of the healthcare consulting field. Ability to extrapolate from the specific to the general and interpret from the general to the specific.
• Analytic Skills: Framing macro problems into action steps or work plans for resolutions. Structuring a persuasive client presentation based on in-depth or expansive excel spreadsheets. Demonstrable interpretive and solution identification skills with the ability to understand multiple types of quantitative and qualitative data heightened with strong resolution skills.
• Collaboration and Teamwork: Ability to give and receive constructive feedback and work effectively across the organization to accomplish team goals is critical. The successful candidate must possess excellent judgment, management, and conflict resolution skills. Ability to work with team members to convey results, incorporate enhancements and productionize processes across projects. Must be able to understand the dynamics of how a team interconnects and relies upon every member.
• Strategic Thinking: Conceptualize outside of the aspects of a project at hand, with an ability to visualize how the work contributes to and drives forward the overall project.
• Solutions oriented: must be able to display resourcefulness and confidence under pressure
• Resilience: must be able to look past obstacles and roadblocks, ask questions and for support, and find their way around any obstacle.

Global trials for oncology, rare diseases and other complex diseases face unique challenges. Precision partners with our clients to meet them head-on through our extensive footprint across the globe. We succeed by pairing personalized clinical services with translational medicine excellence, making us the first fully integrated clinical research organization created expressly to help advance the promises of precision medicine.

Modern biomarker-informed therapeutic and diagnostic development programs involve a complex operational and data ecosystem. Multiple data streams flow from sites, central labs, and specialty labs.

At Precision, we understand that data isn't enough. Clients need information, or data with context, to make decisions that impact patient health.

Position Summary: 

The Documents Specialist II is responsible for preparing TMF plans, document QC and indexing in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Precision Standard Operating Procedures (SOPs) as appropriate.

Essential functions of the job include but are not limited to:

• Perform document QC and indexing within eTMF for assigned studies
• Monitor document submission and timely document process, to avoid developing a backlog; escalate as needed to eTMF Management for support.
• Distribute TMF metrics. Follow-up on document in clarification and ensure these are resolved timely.
• Manage the close-out activities of assigned studies, including timeline for final document submission, wrap up of document processing, close out of all documents in close-out, requesting the eTMF export, transfer to the Client and get the Acknowledgement of Receipt.

Qualifications:

• 4-year college degree or equivalent combination of education and experience, ideally in a business, scientific or healthcare discipline.
• Minimum 5 years of clinical trial experience. Minimum 3 years of experience with TMF and/or eTMF

Other Required:

• Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint). Ability to speak English proficiently (professional level)

Competencies:

• Demonstrates, or is able to be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance.
• Demonstrates solid interpersonal skills. Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
• Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders.
• Communicates both verbally and in written form in an efficient and professional manner. Demonstrates values and a work ethic consistent with Precision Values and Company Principles.

Global trials for oncology, rare diseases and other complex diseases face unique challenges. Precision partners with our clients to meet them head-on through our extensive footprint across the globe. We succeed by pairing personalized clinical services with translational medicine excellence, making us the first fully integrated clinical research organization created expressly to help advance the promises of precision medicine.

Modern biomarker-informed therapeutic and diagnostic development programs involve a complex operational and data ecosystem. Multiple data streams flow from sites, central labs, and specialty labs.

At Precision, we understand that data isn't enough. Clients need information, or data with context, to make decisions that impact patient health.

Position Summary: 

The Documents Specialist II is responsible for preparing TMF plans, document QC and indexing in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Precision Standard Operating Procedures (SOPs) as appropriate.

Essential functions of the job include but are not limited to:

• Perform document QC and indexing within eTMF for assigned studies
• Monitor document submission and timely document process, to avoid developing a backlog; escalate as needed to eTMF Management for support.
• Distribute TMF metrics. Follow-up on document in clarification and ensure these are resolved timely.
• Manage the close-out activities of assigned studies, including timeline for final document submission, wrap up of document processing, close out of all documents in close-out, requesting the eTMF export, transfer to the Client and get the Acknowledgement of Receipt.

Qualifications:

• 4-year college degree or equivalent combination of education and experience, ideally in a business, scientific or healthcare discipline.
• Minimum 5 years of clinical trial experience. Minimum 3 years of experience with TMF and/or eTMF

Other Required:

• Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint). Ability to speak English proficiently (professional level)

Competencies:

• Demonstrates, or is able to be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance.
• Demonstrates solid interpersonal skills. Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
• Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders.
• Communicates both verbally and in written form in an efficient and professional manner. Demonstrates values and a work ethic consistent with Precision Values and Company Principles.

Job Description

Position Summary:

The primary responsibility of the Clinical Systems Administrator is to provide business administration support for the Sponsor’s clinical systems, including but not limited to eTMF/CTMS, IRT and EDC systems (i.e., Veeva Clinical Vault and Medidata CTMS). The Clinical Systems Administrator will work with the Clinical Systems Manager/Sr. Manager and Project teams to ensure on-time deliverables and provide clinical systems user support as outlined below.

Essential functions of the job include but are not limited to:

• Responsible for User Access management for internal, sponsor and 3rd party access requests to the Clinical Systems and other business systems.
• Manages the data entry into the Global Directory within Precisions Clinical System of all Sites, Institutions and update as required.
• Manages the creation of studies, countries and sites within the Clinical System
• Responsible for resolving help desk tickets assigned, either by answering questions, trouble shoot problems or identify system performance issues or deficiencies.
• Perform Clinical System modifications and updates to picklists, field requirements
• Manages the review of Clinical System processes and procedures
• Supports with initiating the integrations between the Clinical system and Electronic Data Capture system
• Performs archival steps within the Clinical System as the request was received.
• Support the leads or manager in any ad-hoc tasks assigned.

Qualifications:

Minimum Required:

• Degree, or equivalent experience ideally in a business, scientific or healthcare discipline
• 2 years’ clinical trial experience with 2 years of experience with Clinical Systems

Other Required:

• Experience in clinical trial systems (e.g., CTMS, EDC, eTMF and RTMS) with detailed understanding of requirements gathering, documentation, configuration and integrations.

Preferred:

• Demonstrate skills in effective communication (written, oral, and presentation) to all levels including end-users, vendors, and Management Teams.
• Possess the ability to effectively communicate business needs to IT technology partners.

Skills:

• Ability to resolve issues independently with good judgement to escalate appropriately.
• Ability to learn new systems and integration requirements.
• Strong interpersonal, verbal and written communication skills

Job Description

Position Summary:

The primary responsibility of the Clinical Systems Administrator is to provide business administration support for the Sponsor’s clinical systems, including but not limited to eTMF/CTMS, IRT and EDC systems (i.e., Veeva Clinical Vault and Medidata CTMS). The Clinical Systems Administrator will work with the Clinical Systems Manager/Sr. Manager and Project teams to ensure on-time deliverables and provide clinical systems user support as outlined below.

Essential functions of the job include but are not limited to:

• Responsible for User Access management for internal, sponsor and 3rd party access requests to the Clinical Systems and other business systems.
• Manages the data entry into the Global Directory within Precisions Clinical System of all Sites, Institutions and update as required.
• Manages the creation of studies, countries and sites within the Clinical System
• Responsible for resolving help desk tickets assigned, either by answering questions, trouble shoot problems or identify system performance issues or deficiencies.
• Perform Clinical System modifications and updates to picklists, field requirements
• Manages the review of Clinical System processes and procedures
• Supports with initiating the integrations between the Clinical system and Electronic Data Capture system
• Performs archival steps within the Clinical System as the request was received.
• Support the leads or manager in any ad-hoc tasks assigned.

Qualifications:

Minimum Required:

• Degree, or equivalent experience ideally in a business, scientific or healthcare discipline
• 2 years’ clinical trial experience with 2 years of experience with Clinical Systems

Other Required:

• Experience in clinical trial systems (e.g., CTMS, EDC, eTMF and RTMS) with detailed understanding of requirements gathering, documentation, configuration and integrations.

Preferred:

• Demonstrate skills in effective communication (written, oral, and presentation) to all levels including end-users, vendors, and Management Teams.
• Possess the ability to effectively communicate business needs to IT technology partners.

Skills:

• Ability to resolve issues independently with good judgement to escalate appropriately.
• Ability to learn new systems and integration requirements.
• Strong interpersonal, verbal and written communication skills

Position Summary:

The Safety Submission Specialist, under minimal supervision, will assume the responsibility of reviewing and transmission of required individual cases safety reports (ICSRs) for submission (paper and electronic) to global regulatory agencies, business partners, affiliates and other destinations. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting.

 Essential functions of the job include but are not limited to:

• Monitor the Drug Safety Inbox for incoming submission acknowledgements and confirmations of expedited reports
• Maintain various spreadsheets, including but not limited to distribution/submission trackers
• Generate final clinical trial regulatory reports (e.g., CIOMS I, MedWatch 3500A, XML) from the global safety database for distribution/submission
• Prepare and distribute final submission documents, including Investigator Safety Letter
• Perform case closure and electronic filing of SAE related documentation
• Complete expedited report deviations which includes initiation, investigation, extension requests, and CAPAs, as appropriate
• Perform SAE reconciliation and send queries, as appropriate
• Reconcile and send SUSAR Gap Packs
• Maintain and update expedited email distribution lists
• Reconcile compliance metrics
• Support generation of overall distribution/submission compliance metrics
• Monitor regulatory intelligence databases for regulation updates and provides country specific reporting information to support the development of Safety Reporting Plans
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process
• Attends Department meetings

Qualifications:

Minimum Required:

• Must have sufficient experience and a demonstrated knowledge and understanding of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance
• Knowledge of the ARGUS Safety Database
• Minimum 2 years of experience in clinical trial drug safety in the Pharma/CRO industry
• Experience with EMA EudraVigilance, UK MHRA and other recognised reporting portals
• BA/BS preferred

Position Summary:

The Safety Submission Specialist, under minimal supervision, will assume the responsibility of reviewing and transmission of required individual cases safety reports (ICSRs) for submission (paper and electronic) to global regulatory agencies, business partners, affiliates and other destinations. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting.

 Essential functions of the job include but are not limited to:

• Monitor the Drug Safety Inbox for incoming submission acknowledgements and confirmations of expedited reports
• Maintain various spreadsheets, including but not limited to distribution/submission trackers
• Generate final clinical trial regulatory reports (e.g., CIOMS I, MedWatch 3500A, XML) from the global safety database for distribution/submission
• Prepare and distribute final submission documents, including Investigator Safety Letter
• Perform case closure and electronic filing of SAE related documentation
• Complete expedited report deviations which includes initiation, investigation, extension requests, and CAPAs, as appropriate
• Perform SAE reconciliation and send queries, as appropriate
• Reconcile and send SUSAR Gap Packs
• Maintain and update expedited email distribution lists
• Reconcile compliance metrics
• Support generation of overall distribution/submission compliance metrics
• Monitor regulatory intelligence databases for regulation updates and provides country specific reporting information to support the development of Safety Reporting Plans
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process
• Attends Department meetings

Qualifications:

Minimum Required:

• Must have sufficient experience and a demonstrated knowledge and understanding of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance
• Knowledge of the ARGUS Safety Database
• Minimum 2 years of experience in clinical trial drug safety in the Pharma/CRO industry
• Experience with EMA EudraVigilance, UK MHRA and other recognised reporting portals
• BA/BS preferred

Position Summary:

The Investigator Grants Associate II position is designed to be a key member of the project team while providing grant administration processing and financial support to the Project Team and Finance Teams of Precision’s clients. The position requires the candidate to be detail oriented, meticulous, with advanced organizational skills with the ability to handle large volumes of confidential financial information in a fast-paced environment.

Essential Functions of the job include but are not limited to:

• Serve as a financial member of the Project Team with the goal to contribute towards timely, efficient, and accurate preparation and tracking of site payments
• Review the financial section of the Clinical Trial Agreement (CTA) to prepare the tracking workbook for site payments on a project-by-project and site-by-site basis
• Responsible for maintaining the advance balance tracking on a project-by-project basis to ensure that sufficient prepaid funds are on-hand to make site payments
• Work with the respective Project Directors and Project Managers to provide guidance on how to populate the site payment workbook to ensure visits eligible for payment are tracked and processed
• Ensure that the investigator site payment workbook is financially calculating all fields correctly to facilitate accurate site payments
• Prepare the site payment package for the Project Director/Project Manager review and approval
• Communicate approved payments based upon the terms and conditions of the CTA within the Finance Department and this step will facilitate entry into the financial systems and payment processing
• Preparation of Aggregate Spend (Sunshine Act) Medicare/Medicaid (MMSE) reporting as applicable
• Preparation of site payment reconciliations
• Maintenance of the investigator grant dedicated mailbox
• Coach and Mentor teammates on Investigator Grants Team
• Ad hoc financial tasks and duties as assigned by the Senior Manager, Global Investigator Grants
• Provides support to the Project Team by managing the Investigator Grants pass through budget.
• Ability to collect data pertaining to patient activity at each site in the workbook use this data to:
• Create accurate client accrual
• Pay sites based on Fully Executed Clinical Trial Agreement
• Project costs to monitor overall budget health
• Ability to communicate with sites and clients via email to resolve inquiries. 
• Exhibits self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
• Ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates

Qualifications:

Minimum Required:

• 4-year degree or local country equivalent
• 3-year Clinical Research Experience
• Prior Accounts Payable experience in global payments.

Other Required:

• Strong analytical skills
• Excellent time management skills
• Ability to drive and meet critical deadlines
• Analyze, reconcile, and communicate financial results with all levels of project team, both internal and at the investigative sites
• Strong proficiency in Microsoft Excel
• Excellent communication skills, both verbal and written
• Extremely detail oriented and process driven 

Preferred:

• Investigator Payment Specialist, Senior background
• Exposure to investigator contracts and budgets

Skills:

• Solid working knowledge and understanding and ability to use MS Office Suite products
• Intermediate to Advance Excel skills
• Proactive communication style
• Ability to work independently, as a team player

Competencies:

• Demonstrates a working knowledge of excel for the purpose of tracker maintenance
• Resolves payment related issues and prioritizes workload to meet deadlines with little support from management
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
• Motivates other members of the project team to meet financial timelines and project goals.
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
• Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, and positive interactions with customers and teammates, including good interpersonal skills
• Communicates both verbally and in written form in professional, clear, and concise manner
• Ability to handle large volumes of financial and confidential data in a highly organized manner

• Possesses practical knowledge of IT tools and systems in use by the Finance Department for tasks applicable to grant administration

Position Summary:

The Investigator Grants Associate, Senior position is designed to be a key member of the project team while providing grant administration processing and financial support to the Project Team and Finance Teams of Precision’s clients. The position requires the candidate to be detail oriented, meticulous, with advanced organizational skills with the ability to handle large volumes of confidential financial information in a fast-paced environment.

Essential Functions of the job include but are not limited to:

• Serve as a financial member of the Project Team with the goal to contribute towards timely, efficient, and accurate preparation and tracking of site payments
• Review the financial section of the Clinical Trial Agreement (CTA) to prepare the tracking workbook for site payments on a project-by-project and site-by-site basis
• Responsible for maintaining the advance balance tracking on a project-by-project basis to ensure that sufficient prepaid funds are on-hand to make site payments
• Work with the respective Project Directors and Project Managers to provide guidance on how to populate the site payment workbook to ensure visits eligible for payment are tracked and processed
• Ensure that the investigator site payment workbook is financially calculating all fields correctly to facilitate accurate site payments
• Prepare the site payment package for the Project Director/Project Manager review and approval
• Communicate approved payments based upon the terms and conditions of the CTA within the Finance Department and this step will facilitate entry into the financial systems and payment processing
• Preparation of Aggregate Spend (Sunshine Act) Medicare/Medicaid (MMSE) reporting as applicable
• Preparation of site payment reconciliations
• Maintenance of the investigator grant dedicated mailbox
• Coach and Mentor teammates on Investigator Grants Team
• Ad hoc financial tasks and duties as assigned by the Senior Manager, Global Investigator Grants
• Provides support to the Project Team by managing the Investigator Grants pass through budget.
• Ability to collect data pertaining to patient activity at each site in the workbook use this data to:
• Create accurate client accrual
• Pay sites based on Fully Executed Clinical Trial Agreement
• Project costs to monitor overall budget health
• Ability to communicate with sites and clients via email to resolve inquiries. 
• Exhibits self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
• Ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates

Qualifications:

Minimum Required:

• 4-year degree or local country equivalent
• 3-year Clinical Research Experience
• Prior Accounts Payable experience in global payments.

Other Required:

• Strong analytical skills
• Excellent time management skills
• Ability to drive and meet critical deadlines
• Analyze, reconcile, and communicate financial results with all levels of project team, both internal and at the investigative sites
• Strong proficiency in Microsoft Excel
• Excellent communication skills, both verbal and written
• Extremely detail oriented and process driven 

Preferred:

• Investigator Payment Specialist, Senior background
• Exposure to investigator contracts and budgets

Skills:

• Solid working knowledge and understanding and ability to use MS Office Suite products
• Intermediate to Advance Excel skills
• Proactive communication style
• Ability to work independently, as a team player

Competencies:

• Demonstrates a working knowledge of excel for the purpose of tracker maintenance
• Resolves payment related issues and prioritizes workload to meet deadlines with little support from management
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
• Motivates other members of the project team to meet financial timelines and project goals.
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
• Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, and positive interactions with customers and teammates, including good interpersonal skills
• Communicates both verbally and in written form in professional, clear, and concise manner
• Ability to handle large volumes of financial and confidential data in a highly organized manner

• Possesses practical knowledge of IT tools and systems in use by the Finance Department for tasks applicable to grant administration

Position Summary:

The Senior Clinical Data Engineer leads the strategic development and optimization of clinical data systems to support regulatory compliance, advanced analytics, and operational excellence across global trials. This role drives enterprise-level data standardization initiatives,  and architects scalable validation frameworks to proactively address systemic data issues. With deep expertise in Python, R, SQL, and SAS, the engineer builds and maintains modular codebases, sets coding standards, and mentors junior engineers. The role also oversees regulatory alignment with GCP and FDA 21 CFR Part 11, establishing robust documentation and audit trail protocols. Through dynamic dashboards and analytics tools, the engineer delivers actionable insights into trial performance and data quality. As a strategic liaison across Biostatistics, Clinical Operations, and Regulatory Affairs, the engineer translates clinical requirements into scalable technical solutions and leads the design of secure, high-performance databases and ETL pipelines integrating data from diverse clinical systems.

Essential functions of the job include but are not limited to:

Data Standardization & Mapping -  Spearhead the development of enterprise-level data mapping strategies that transform raw clinical data into standardized formats for high-impact analytics. Lead the adoption and governance of data standards across programs to ensure regulatory alignment and consistency. 

Data Quality Assurance - Design and implement robust, scalable validation frameworks that proactively detect and resolve systemic data issues. Serve as a strategic partner to Clinical Data Managers and cross-functional teams, driving continuous improvement in data integrity across global trials

Programming & Scripting - Architect and maintain advanced, modular codebases using Python, R, SQL, and SAS to support complex data engineering workflows. Establish coding standards and mentor junior engineers in automation, reproducibility, and performance optimization. Example use cases includes edit checks, reconciliations, exception listings, programmed protocol deviations, resource projections based on site data entry volume

Regulatory Compliance & Documentation - Lead compliance initiatives to ensure all data systems and workflows meet GCP, FDA 21 CFR Part 11, and evolving global regulatory requirements. Define documentation protocols and oversee audit trail governance to support inspection readiness and transparency

Reporting & Visualization - Develop and operationalize dynamic dashboards and analytics tools that provide real-time insights into data quality, trial progress, and operational KPIs. Translate complex datasets into actionable intelligence for clinical and regulatory stakeholders.

Collaboration & Cross-Functional Support - Act as a strategic liaison between Clinical Data Engineering and Biostatistics, Clinical Operations, and Regulatory Affairs. Translate clinical and scientific requirements into scalable technical solutions that support study execution and data delivery.

Database Design & Optimization - Lead the design and optimization of secure, high-performance relational databases and data lakes. Ensure infrastructure scalability, query efficiency, and data governance for large-scale clinical datasets

Qualifications: 

• Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience
• Minimum 6 years experience in clinical monitoring, clinical trial management  or equivalent
• Advanced programming and automation skills; database design; dashboard development; CDISC governance.

Other Required:

• Highly effective oral and written communication skills with the ability to communicate effectively with project team members
• Excellent organizational and time management skills
• Ability to work in a team or independently as required
• Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems and clinical systems
• Proficiency in statistical analysis and data monitoring tools.
• Detail-oriented with strong analytical and problem-solving skills
• Demonstrated experience with integrated risk planning & management
• Ability to mentor junior team members

Preferred:

• CRO experience as a Clinical Data Engineer or Programmer

Skills:

• Strong analytical and problem-solving skills with attention to data quality and integrity.
• Ability to work with large, complex datasets from multiple sources.
• Effective communication skills to collaborate with cross-functional teams.
• Knowledge of data governance, privacy, and security best practices in clinical research.

Competencies

• Collaboration: Works effectively with clinical, statistical, and technical teams to align data strategies with study goals.
• Accountability: Takes ownership of data engineering deliverables and ensures timely, high-quality outputs.
• Adaptability: Thrives in a fast-paced, evolving environment with shifting priorities and timelines.
• Compliance-Oriented: Maintains a strong focus on regulatory compliance and data traceability.

Position Summary:

The Senior Clinical Data Engineer leads the strategic development and optimization of clinical data systems to support regulatory compliance, advanced analytics, and operational excellence across global trials. This role drives enterprise-level data standardization initiatives,  and architects scalable validation frameworks to proactively address systemic data issues. With deep expertise in Python, R, SQL, and SAS, the engineer builds and maintains modular codebases, sets coding standards, and mentors junior engineers. The role also oversees regulatory alignment with GCP and FDA 21 CFR Part 11, establishing robust documentation and audit trail protocols. Through dynamic dashboards and analytics tools, the engineer delivers actionable insights into trial performance and data quality. As a strategic liaison across Biostatistics, Clinical Operations, and Regulatory Affairs, the engineer translates clinical requirements into scalable technical solutions and leads the design of secure, high-performance databases and ETL pipelines integrating data from diverse clinical systems.

Essential functions of the job include but are not limited to:

Data Standardization & Mapping -  Spearhead the development of enterprise-level data mapping strategies that transform raw clinical data into standardized formats for high-impact analytics. Lead the adoption and governance of data standards across programs to ensure regulatory alignment and consistency. 

Data Quality Assurance - Design and implement robust, scalable validation frameworks that proactively detect and resolve systemic data issues. Serve as a strategic partner to Clinical Data Managers and cross-functional teams, driving continuous improvement in data integrity across global trials

Programming & Scripting - Architect and maintain advanced, modular codebases using Python, R, SQL, and SAS to support complex data engineering workflows. Establish coding standards and mentor junior engineers in automation, reproducibility, and performance optimization. Example use cases includes edit checks, reconciliations, exception listings, programmed protocol deviations, resource projections based on site data entry volume

Regulatory Compliance & Documentation - Lead compliance initiatives to ensure all data systems and workflows meet GCP, FDA 21 CFR Part 11, and evolving global regulatory requirements. Define documentation protocols and oversee audit trail governance to support inspection readiness and transparency

Reporting & Visualization - Develop and operationalize dynamic dashboards and analytics tools that provide real-time insights into data quality, trial progress, and operational KPIs. Translate complex datasets into actionable intelligence for clinical and regulatory stakeholders.

Collaboration & Cross-Functional Support - Act as a strategic liaison between Clinical Data Engineering and Biostatistics, Clinical Operations, and Regulatory Affairs. Translate clinical and scientific requirements into scalable technical solutions that support study execution and data delivery.

Database Design & Optimization - Lead the design and optimization of secure, high-performance relational databases and data lakes. Ensure infrastructure scalability, query efficiency, and data governance for large-scale clinical datasets

Qualifications: 

• Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience
• Minimum 6 years experience in clinical monitoring, clinical trial management  or equivalent
• Advanced programming and automation skills; database design; dashboard development; CDISC governance.

Other Required:

• Highly effective oral and written communication skills with the ability to communicate effectively with project team members
• Excellent organizational and time management skills
• Ability to work in a team or independently as required
• Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems and clinical systems
• Proficiency in statistical analysis and data monitoring tools.
• Detail-oriented with strong analytical and problem-solving skills
• Demonstrated experience with integrated risk planning & management
• Ability to mentor junior team members

Preferred:

• CRO experience as a Clinical Data Engineer or Programmer

Skills:

• Strong analytical and problem-solving skills with attention to data quality and integrity.
• Ability to work with large, complex datasets from multiple sources.
• Effective communication skills to collaborate with cross-functional teams.
• Knowledge of data governance, privacy, and security best practices in clinical research.

Competencies

• Collaboration: Works effectively with clinical, statistical, and technical teams to align data strategies with study goals.
• Accountability: Takes ownership of data engineering deliverables and ensures timely, high-quality outputs.
• Adaptability: Thrives in a fast-paced, evolving environment with shifting priorities and timelines.
• Compliance-Oriented: Maintains a strong focus on regulatory compliance and data traceability.

Position Summary:

The Senior Clinical Data Associate provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision.  Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed.   This position may perform database development and testing, as well as additional data management activities.

Essential functions of the job include but are not limited to:

• Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner
• May perform data entry for paper-CRF studies, as needed
• May perform quality control of data entry
• May provide input into timelines. Ensure that clinical data management deadlines are met with quality. May assess resource needs for assigned projects, as needed.
• Assist in developing CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• May assist in building clinical databases
• Conduct database build UAT and maintain quality controlled database build documentation. May oversee overall quality of the clinical database.
• Assist in specifying requirements for all edit check types e.g., electronic, manual data review, edit checks, etc.
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Assist with coordinating SAE/AE reconciliation
• Assist with liaising with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
• May assist with SAS programming and quality control of SAS programs used in the Data Management department
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
• May assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• Perform other duties as assigned.

 Qualifications:

Minimum Required:

• 5+ years’ experience
• Bachelors and/or a combination of related experience 

Other Required:

• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
• Able to handle a variety of clinical research tasks.
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral.
• Basic knowledge of drug, device and/or biologic development and effective data management practices.

Preferred:

• Experience in a clinical, scientific or healthcare discipline.
• Dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
• Oncology and/or Orphan Drug therapeutic experience

Skills:

Demonstrates strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance, as well as the ability to implement and drive outcomes

 Competencies:

• Motivates project team members to meet timelines and project goals
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
• Resolves project related problems and prioritizes workload to meet deadlines with minimal support
• Exhibits a high degree of self-motivation, and can work and plan independently as well as in a team environment
• Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills

Position Summary:

The Senior Clinical Data Associate provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision.  Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed.   This position may perform database development and testing, as well as additional data management activities.

Essential functions of the job include but are not limited to:

• Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner
• May perform data entry for paper-CRF studies, as needed
• May perform quality control of data entry
• May provide input into timelines. Ensure that clinical data management deadlines are met with quality. May assess resource needs for assigned projects, as needed.
• Assist in developing CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• May assist in building clinical databases
• Conduct database build UAT and maintain quality controlled database build documentation. May oversee overall quality of the clinical database.
• Assist in specifying requirements for all edit check types e.g., electronic, manual data review, edit checks, etc.
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Assist with coordinating SAE/AE reconciliation
• Assist with liaising with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
• May assist with SAS programming and quality control of SAS programs used in the Data Management department
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
• May assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• Perform other duties as assigned.

 Qualifications:

Minimum Required:

• 5+ years’ experience
• Bachelors and/or a combination of related experience 

Other Required:

• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
• Able to handle a variety of clinical research tasks.
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral.
• Basic knowledge of drug, device and/or biologic development and effective data management practices.

Preferred:

• Experience in a clinical, scientific or healthcare discipline.
• Dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
• Oncology and/or Orphan Drug therapeutic experience

Skills:

Demonstrates strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance, as well as the ability to implement and drive outcomes

 Competencies:

• Motivates project team members to meet timelines and project goals
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
• Resolves project related problems and prioritizes workload to meet deadlines with minimal support
• Exhibits a high degree of self-motivation, and can work and plan independently as well as in a team environment
• Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills

The Data Engineer will work closely with clients and the eCS Biometrics team to optimize the elluminate® platform for end-to-end solutions to aggregate, transform, access and report on clinical data throughout the life cycle of a clinical trial.  This includes study design in elluminate®, collaboration on specifications, and configuration of the various modules to including Data Central, Clinical Data Analytics and Trial Operational Analytics, Risk-Based Quality Management (RBQM), Statistical Computing Environment (SCE) and Operational Insights. The Data Engineer will be involved in standard ETL activities as well as programming custom listings, visualizations and analytics tools using Mapper and Qlik. The position involves a high level of quality control as well as adherence to standard operation procedures and work instructions and a constant drive towards automation and process improvement.

KEY TASKS & RESPONSIBILITIES

• Design, develop, test, and deploy highly efficient code for supporting SDTM, Custom reports and Visualizations using tools like MS SQL, elluminate® Mapper and Qlik
• Configure ETL processes to support of the aggregation and standardization of clinical data from various sources including EDC systems, SAS and central laboratory vendors
• Work with Analytics developers, other team members and clients to review the business requirements and translate them into database objects and visualizations
• Manage multiple timelines and deliverables (for single or multiple clients) and managing client communications as assigned
• Provide diagnostic support and fix defects as needed
• Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures
• Other duties as assigned

CANDIDATE’S PROFILE

Education & Experience

• 3+ years of professional experience preferred
• Bachelor's degree or equivalent experience preferred
• Experience with database/warehouse architecture, design and development preferred
• Knowledge of various data platforms and warehouses including SQL Server, DB2, Teradata, AWS, Azure, Snowflake, etc.
• Understanding of Cloud / Hybrid data architecture concepts is a plus
• Knowledge of clinical trial data is a plus - CDISC ODM, SDTM, or ADAM standards
• Experience in Pharmaceutical/Biotechnology/Life Science industry is a plus

Professional Skills

• Critical thinking, problem solving and strong initiative
• Communication and task management skills while working with technical and non-technical teams (both internal to eCS and clients)
• Must be team oriented with strong collaboration, prioritization, and adaptability skills
• Excellent knowledge of English; verbal and written communication skills with ability to interact with users and clients providing solutions
• Excited to learn new tools and product modules and adapt to changing technology and requirements
• Experience in the Life Sciences industry, CRO / Clinical Trial regulated environment preferred

Technical Skills

• Proficient in SQL, T-SQL, PL/SQL programing
• Experience in Microsoft Office Applications, specifically MS Project and MS Excel
• Familiarity with multiple Database Platforms: Oracle, SQL Server, Teradata, DB2 Oracle
• Familiarity with Data Reporting Tools: QlikSense, QlikView, Spotfire, Tableau, JReview, Business Objects, Cognos, MicroStrategy, IBM DataStage, Informatica, Spark or related
• Familiarity with other languages and concepts: .NET, C#, Python, R, Java, HTML, SSRS, AWS, Azure, Spark, REST APIs, Big Data, ETL, Data Pipelines, Data Modelling, Data Analytics, BI, Data Warehouse, Data Lake or related

**We are only hiring for this role in the CST or EST time zones**

At Greenlight Guru, we help the world’s most innovative medical device companies bring high-quality, life-changing products to market faster. We serve 1000+ global customers with our quality management and clinical data capture software, helping them get their products on the market and keep them there. 

When you join the team at Greenlight Guru, you’ll be a part of a collaborative, mission-driven team working in one of the most exciting and rewarding industries on the planet. Backed by JMI Equity, one of the premier growth equity firms for SaaS companies, Greenlight Guru is growing—and looking for individuals who are difference makers. Is that you?

We are looking for a commercially-minded, revenue-driven, highly technical Solutions Engineer to join our organization with a heavy focus on selling to software engineering teams. Reporting to the Director of Product Marketing, you are responsible for translating our product strategy into confident, effective value-based selling. You will work alongside Sales to support live deals, bring product and technical depth into buyer conversations, and turn field experience into reusable assets that scale across GTM. You focus on the last mile of the buying journey - proving technical fit, reducing risk, and helping buyers move forward with confidence. While you are a strategic partner to Sales on active deals, being situated within the Product Marketing team allows you to act as a critical bridge between our product’s capabilities and our market-facing message. You are a technical storyteller who knows how to connect "how it works" with "why it matters." You’ll use real-world deal experience to stress-test and refine our positioning, competitive strategy, and the assets we use to win.

Responsibilities

Value Selling & Deal Execution

You own technical confidence in active deals and are accountable for buyer certainty in our technical fit. Your performance is largely measured by your impact on revenue.

• Technical Discovery & Diagnosis: Lead additional deep-dive discovery during demos to uncover a prospect’s current tech stack and pain points. You help diagnose the technical "why" before prescribing a solution.
• Value-Based Demonstrations: Deliver demos tailored to the buyer’s specific goals and success criteria. Lead with value and differentiation, not feature walkthroughs.
• Trial & Evaluation Ownership: Own the trial experience end-to-end, including setup, guidance, and success criteria. Ensure trials clearly demonstrate value and differentiation.
• Technical Deal Support: Act as a persistent partner in the deal, not a one-time resource. Stay current on deal status, identify technical risks, and partner with AEs to move deals forward.
• Expansion & RFP Support: Support expansions and at-risk renewals. Partner with AEs and PMM to ensure RFPs have high positioning impact and technical clarity.

Technical Assets & Demo Environments

You are responsible for maintaining the "technical sales toolkit," ensuring the GTM team has accurate, field-ready assets to sell efficiently.

• Scalable Asset Creation: Build and maintain reusable technical sales assets—such as walkthroughs, video snippets, and PoC templates for APIs/integrations—that help the field scale.
• Demo Environment Ownership: Maintain stable and accessible demo environments. You ensure demo data supports realistic, value-based storytelling for our core personas.
• Demo Narrative: Collaborate with PMM to ensure the core demo narratives are technically accurate and reflect how the product is actually used in the field.

Cross-Functional Collaboration & Enablement

You act as the resident technical authority, ensuring seamless alignment between the Product, Marketing, and Sales organizations.

• Cross-Functional Collaboration: Serve as the trusted technical lead for AEs, AMs, and CSMs. You are a strong collaborator who bridges the gap between technical details and GTM strategy.
• Product Readiness: Stay current on what’s shipping and why it matters. Translate new features into demo-ready flows, technical FAQs, and narratives for the GTM team.
• Field Intelligence Loop: Serve as the "voice of the buyer." Identify patterns in technical objections or competitive gaps and provide clear, actionable feedback to Product to influence the roadmap.

Candidate Profile

• Commercially Minded: You understand that technical depth exists to win deals and drive revenue.
• Strategic Partner: You know when to lead technically and when to support the broader sales strategy.
• Solution Storyteller: You can translate product capabilities into outcomes that actually matter to a buyer.
• Ownership Mindset: You treat deals, proof points, and internal process improvements as your personal responsibility.

Qualifications

• Technical Sales Experience: Proven track record delivering value-led technical demonstrations to software engineers and highly technical buyers, translating complex platform capabilities (APIs, integrations, developer workflows) into clear business and technical outcomes.
• Software Development Fluency: Strong working knowledge of modern SDLC practices, including requirements management, Git-based version control, CI/CD workflows, and release processes, with hands-on experience using Jira and similar developer tools (e.g., issue tracking, sprint boards, workflow configuration) in real engineering environments.
• API & Integration Literacy: Practical understanding of REST APIs, authentication methods, and system integrations - confident discussing how systems connect, how data flows between platforms, and how traceability or automation is maintained.
• Code Familiarity: Hands-on familiarity with code platforms (you have written or actively used code-based tools) and can speak fluently about repositories, commits, pull requests, and automation workflows.
• SaaS Background: Experience at a small-to-mid-sized SaaS company where you helped build or refine the SE function, processes, or demo environments - not just operate within an established structure.
• Revenue Impact: A clear track record of directly supporting revenue, advancing complex opportunities, and influencing deal outcomes in partnership with Account Executives.
• Learning & Ownership Mindset: Thrives in a fast-moving, evolving environment — actively seeks feedback, adapts quickly, rolls with change, and contributes ideas that help the team continuously improve how we sell and deliver technical value.
• Nice to Have: Experience in life sciences/medtech environments or running technical proof-of-concepts.

Benefits you’ll enjoy:

• Flexible Paid Time Off policy and working hours
• Home Office stipend for new hires
• Multiple Medical Insurance options, plus Dental and Vision
• 401k (with company match) 
• Equity Program Eligibility (based on role and/or tenure)
• Paid Maternity and Paternity Leave
• Disability insurance

Greenlight Guru is an Equal Opportunity Employer. Individuals seeking employment at Greenlight Guru are considered regardless of race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. If you need assistance or accommodations to submit your application for this position, please email careers@greenlight.guru.

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!

eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

OVERVIEW
The Implementation Consultant at eClinical Solutions is responsible for liaising with our clients and internal stakeholders to align our client’s clinical data strategy to tools and functionality within elluminate. The Implementation Consultant is a savvy pharmaceutical/biotech/CRO professional with advanced experience in the handling, cleansing or analysis of clinical data. The Implementation Consultant has excellent organization skills and is a creative solution-oriented individual. The Implementation Consultant has experience with the delivery of technical products and exhibits prowess with analytic data review tools.
KEY TASKS & RESPONSIBILITIES
➢ Participate in elluminate implementations by providing business process and product best practices consulting services to support the technical and project management team members.
➢ Provide efficient and effective implementation services for clients, by ensuring appropriate requirements gathering through sound assessment of the clients’ elluminate environment and expectations.
➢ Consult in a post-implementation capacity to measure and drive increase in the ROI customers receive from elluminate.
➢ Steer productive elluminate implementation workshops through a consultative process, administer training sessions, if necessary, and provide high-quality support
➢ Align client clinical data review objectives to functionality in elluminate and deliver gap analysis where applicable.
➢ Collaborate with technical, engineering, product, and project management team members to develop new/enhanced product offerings in alignment with client objectives. Draft specifications and prototypes as needed.
➢ Configure elluminate software to meet the client requirements.
➢ Support elluminate training team in preparation of course materials and delivery of courses
➢ Assist sales effort to drive new sales by delivering Proof of Concept, Prototypes/Pilots and targeted presentations that fulfill client expectations.
➢ Collaborate with Marketing to develop client specific case studies and share client success.
➢ Participate in development of new processes, best practices, and recommend improvements to all procedures to ensure optimal level of client satisfaction.Ensure compliance with eClinical Solutions and industry quality standards, guidelines, and procedures.
➢ Other duties as assigned

Candidate Profile:

Education & Experience
➢ Four-year college degree or higher preferred, analytic discipline a plus and/or equivalent work experience preferred.
➢ Experience in a software development environment a plus preferred.
➢ 5+ years’ experience Pharmaceutical/Biotechnology/CRO preferred
Professional Skills
➢ Ability to think logically to solve complex problems.
➢ Excellent verbal and written communication skills, organizational and time management skills.
➢ Prior management and delivery of technical projects in a professional services environment is a plus
➢ Self-motivating, able to assume responsibility and work autonomously in a professional manner.
Technical Skills
➢ Excellent knowledge of English
➢ Excellent knowledge of the drug development process and clinical trial execution as they relate to data collection, management, analytics and reporting.
➢ Solid understanding of database concepts and ability to use data to optimize reporting, data mapping and programming.
➢ Solid analytical and technical skills and experience with analytic software applications (i.e. Spotfire, J-Review, Qlik, Tableau)
➢ Proficiency in Microsoft Office Applications, specifically MS Project Excel, Visio, PowerPoint, Word
➢ Proficiency with clinical data review and analytics solutions required.
➢ Ensure compliance with eClinical Solutions and industry quality standards, guidelines, and procedures.
➢ Other duties as assigned

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. 

OVERVIEW
The Data Engineer, Sr - I will work closely with clients and provide high level technical consulting services, configuration of the elluminate® platform, development and oversight for specific projects that include trial configuration, quality control, project management, assessing new technologies, process improvements, system validation, SOP development, custom analytics development, clinical software implementations and integrations, platform configuration, ETL and custom analytics development.
As a Data Engineer, Sr - I, you will serve as the primary technical lead, spearheading consulting efforts related to clinical systems software. You will also design and develop reporting programs as needed.
KEY TASKS & RESPONSIBILITIES

• Leading consulting efforts and providing high-level technical consulting services to clients, including configuring the elluminate® platform and overseeing specific projects such as trial configuration, quality control, and project management.
• Designing, developing, testing, and deploying efficient SQL code to support SDTM, custom reports, and visualizations using tools like MS SQL, elluminate® Mapper, and Qlik.
• Providing technical guidance, training, and support to team members and users on processes, technology, and products.
• Managing multiple timelines and deliverables for single or multiple clients, and handling client communications as assigned.
• Possessing high-level debugging skills for ETL or analytical issues by referring to the required source data.
• Demonstrating in-depth knowledge of at least one Elluminate module, with hands-on experience in all other modules.
• Delivering proactive technical support for all client-reported support tickets.
• Facilitating client onboarding workshops and conducting training sessions for end users on the Elluminate platform.
• Configuring, migrating, and supporting the elluminate® platform for assigned clients.
• Creating and maintaining all required specifications and quality control documents as per SOP and processes.
• Ensuring compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures.

CANDIDATE’S PROFILE
Education/Language:

• 5+ years of professional experience in a Services or Consulting role preferred
• Bachelor's or Master's degree in science, technical or business discipline or equivalent experience preferred
• 5+ years in database design and development experience preferred
• Understanding of Cloud / Hybrid data architecture concepts is a plus
• Prior experience in customer facing roles is a plus
• Knowledge of clinical trial data is a plus - CDISC ODM, SDTM, or ADAM standards
• Experience in Pharmaceutical/Biotechnology/Life Science industry is a plus
• Experience in Data Capturing tools (Rave, Veeva, InForm, IVRS)

Professional Skills & Experience:

• Have critical observation and communication skills to Identify any gaps in processes or product
• Ability to work with various technical and non-technical teams both internal to eCS and clients
• Must be team oriented with strong collaboration, prioritization, and adaptability skills
• Excellent knowledge of English; verbal and written communication skills with ability to interact with users and clients providing solutions
• Experience in the Life Sciences industry, CRO / Clinical Trial regulated environment preferred
• Experience in regulatory computer systems validation a strong plus
• Demonstrating strong analytical and problem-solving skills to identify issues and develop creative solutions that drive results.
• Conveying information clearly and concisely to diverse audiences, facilitating understanding and collaboration.
• Working effectively in a team environment, contributing to group objectives, and supporting colleagues.
• Adapting to changing circumstances and accepting new challenges with a positive attitude.
• Understanding clinical trial data and applying CDISC, SDTM/AdAM standards.

Technical Skills & Experience:

• Proficient in SQL, T-SQL, PL/SQL programming or R Package or Python or SAS
• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
• Experience with multiple Database Platforms: Oracle, SQL Server, Teradata, DB2 Oracle
• Experience with Data Reporting Tools: QlikSense, QlikView, Spotfire, Tableau, JReview, Business Objects, Cognos, MicroStrategy, IBM DataStage, Informatica, Spark or related
• Familiarity with other languages and concepts: .NET, C#, Python, R, Java, HTML, SSRS, AWS, Azure, Spark, REST APIs, Big Data, ETL, Data Pipelines, Data Modelling, Data Analytics, BI, Data Warehouse, Data Lake or related

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!

eClinical is a winner of the 2023 Top Workplaces USA national award! We have also received numerous Culture Excellence Awards celebrating our exceptional company vision, values, and employee experience. See all the details here: https://topworkplaces.com/company/eclinical-solutions/

eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

OVERVIEW:

The Data Engineer, Pr will work closely with clients and provide high level technical consulting services, configuration of the elluminate platform, development and oversight for specific projects that include trial configuration, quality control, project management, assessing new technologies, process improvements, system validation, SOP development, custom analytics development, clinical software implementations and integrations. platform configuration, ETL and custom analytics development. The Data Engineer, Pr will be a technical escalation point for the team, design solutions and provide oversight and direction on technical development and implementation aspects to the team of existing data engineers on various software service delivery related activities.

KEY TASKS & RESPONSIBILITIES:

➢ Function as a technical lead to lead consulting efforts related to clinical systems software and design and develop any reporting programs as needed ➢ Provide programming support and quality control for system configuration, Data Extracts, Custom Reports and Visualizations.

 ➢ Manage/Mentor technical resources to deliver client services.

➢ Provide training services as needed to internal and external users working with training staff ➢ Ensure compliance with eClinical and industry quality standards, guidelines, and procedures.

➢ Work closely with Sales Teams on staffing and project delivery services.

➢ Define new/enhanced processes to support new and existing modules in elluminate.

➢ Other duties as assigned.

CANDIDATE’S PROFILE :

Education & Experience:

➢ 10+ years of professional experience, preferably in Services or senior consulting role preferred.

➢ Basic Science/Bachelor of Science or Master of Science degree in Computer Science and/or equivalent work experience preferred .

➢ 8+ years in database design and development experience Position: Data Engineer, Pr ➢ Prior experience of leading technical teams is a plus.

➢ Thorough experience in data warehouse architecture, design, and development.

➢ Knowledge of clinical trial data is a plus - CDISC ODM, SDTM, or ADAM standards .

Professional Skills:

➢ Provide technical leadership and guidance to the team and users .

➢ Ability to steward a solution to its objective resolving challenges, conflicts and priorities .

➢ Have critical observation and communication skills to Identify any gaps in processes or product.

 ➢ Ability to work with various technical and non-technical teams both internal to eCS and clients.

 ➢ Experience in the Life Sciences industry, CRO / Clinical Trial regulated environment preferred .

➢ Experience in regulatory computer systems validation a strong plus .

Technical Skills:

➢ Proficient in SQL, T-SQL, PL/SQL programming or R Package, or Python, or SAS.

➢ Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel .

➢ Experience with multiple Database Platforms: Oracle, SQL Server, Teradata, DB2 Oracle.

➢ Experience with Data Reporting Tools: QlikSense, QlikView, Spotfire, Tableau, JReview, Business Objects, Cognos, MicroStrategy, IBM DataStage, Informatica, Spark or related .

➢ Experience with other languages and concepts: .NET, C#, Python, R, Java, HTML, SSRS, AWS, Azure, Spark, REST APIs, Big Data, ETL, Data Pipelines, Data Modelling, Data Analytics, BI, Data Warehouse, Data Lake or related.

 ➢ Strong familiarity with EDC Systems: Rave, Trial Master, InForm, or Oracle Clinical preferred.

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. 

OVERVIEW

The Senior Software Developer will work closely with Product Manager, Implementation Consultants (ICs) and clients to gather requirements to meet the data analysis need of a company or a client. They must have good collaboration skills. The Senior Software Developer will provide direction on analytics aspects to the team on various analytics related activities.

KEY TASKS & RESPONSIBILITIES

• Experienced in Qlik Sense Architecture design and good knowledge on load script implementation and best practices.
• Hands on experience in Qlik Sense development, dashboarding, data-modelling and reporting techniques.
• Experienced in data integration through extracting, transforming, and loading (ETL) data from various sources.
• Good at Data transformation, the creation of QVD files and set analysis.
• Data Modelling using Dimensional Modelling, Star schema and Snowflake schema.
• Strong SQL skills (SQL Server) to validate the Qlik sense dashboards and to work on internal applications.
• Knowledge on deploying of Qlik Sense application using Qlik Management Console (QMC) is a plus.
• Work with Implementation consultants (ICs), product manager and clients to gather the requirements.
• Configuration, migration, and support of Qlik Sense applications.
• Thoughtful implementation of Qlik Sense best practices for efficiency and re-usability.
• Research and utilize new technologies.
• Collaborate with the Software Quality Assurance (SQA) team to test the applications functionality.
• Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures.
• Manage multiple timelines and deliverables (for single or multiple clients) and managing client communications as assigned.
• Other duties as assigned.

CANDIDATE’S PROFILE

Education/Language:

• Bachelor of Science / BTech / MTech / Master of Science degree in Computer Science and/or equivalent work experience
• Good verbal and written communication skills.

Professional Skills & Experience

• Minimum of 3 - 5 years of experience in implementing end to end business intelligence using Qlik Sense.
• Thorough experience in Qlik Sense architecture, design, develop, test and deployment process.
• Thorough understanding of Qlik Sense best practices (re-usability, efficiency, optimization).
• Knowledge on Clinical Datasets and Standards is a plus. (e.g.: SDTM, CDISC(92,45,101), Q Format, Customized Data formats .. etc.).
• Excellent understanding of relational database concepts, data modelling, and design.
• Excellent knowledge on writing SQL code and ETL procedures using MS-SQL Server.
• Strong Software Development Lifecycle experience (Agile methodology experience is a plus).
• Strong technical project management experience and team leadership skills including scope management, work planning and work delegation.
• Strong troubleshooting skills and use of defect/feature management systems.
• Proven ability to work independently and with technical team members (Startup environment experience is a plus).
• Good verbal and written communication skills.
• Strong analytical skills and strong decision-making capabilities.

Technical Skills & Experience

• 3+ years of experience in Qlik Sense architecture and design.
• 3+ years of experience in develop, test and deploy of Qlik Sense applications.
• 3+ years with SQL Server and ETL process.
• 3+ years with Data modeling (physical & logical).
• Experience with Performance tuning and best practices of Qlik Sense.
• Experience with Dimensional modeling, Star Schema and Snowflake Schema.
• Knowledge of clinical trial data and SDTM standards is a plus.

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!

eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. 

OVERVIEW

The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science.

KEY TASKS & RESPONSIBILITIES

• Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools
• Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance
• Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables
• Perform holistic data review and trending analysis via reporting and elluminate® analytics to proactively identify issue, risks and develop mitigation strategies
• Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data
• Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager
• Perform Query Management
• Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate® Data Central for data cleaning strategy and oversight activities
• Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle
• Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate® Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness
• Collaborate and work as a team to ensure the deliverables are completed on time with high quality
• Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures
• Other duties as assigned

CANDIDATE’S PROFILE

Education & Experience

• 5+ years’ experience in Clinical Data Management preferred
• Bachelor’s degree in a health-related field or equivalent experience preferred
• CCDM Certification preferred

Professional Skills

• Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems
• Strong analytical and strategic thinking skills
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills
• Excellent collaborative skills
• Demonstrated command of the English language with proficiency in both verbal and written communication

Technical Skills

• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Proficient with EDC and Clinical Data Management Systems
• Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred
• Experience with RBQM methodology preferred
• Exposure to CDISC guidelines and standards

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!

eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. 

OVERVIEW

Statistical Programmers provide SAS programming expertise in data extracted from various databases for data transformation of raw data. Develop specifications and programming expertise and validation for Study Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, and develop programming to produce Tables, Listings and Graphs/Figures (TLGs or TLFs) and other reports to support statistical analysis.

KEY TASKS & RESPONSIBILITIES

• Develop specifications for SDTM datasets and SDTM datasets specifications for Clinical Data Analysis.

• Develop SAS programming to produce SDTM datasets and SDTM datasets.

• Develop specifications for Analysis Data Model (ADaM) datasets. 

• Develop SAS programming and validation of ADaM datasets for trial level reporting and integrated safety and efficacy activities.

• Responsible for developing and maintaining programming and validation specifications for TLGs as per requirements provided by the Biostatistician.

• Create and maintain SAS programs to produce outputs to support the analysis and reporting of clinical trials.

• Program and QC data listings, summaries and Graphs as defined in SAP. If required, validate the statistical models used for programming.

• Develop re-usable utility macros to build a macro library to support programming tables, listing and graphs for phase 1-4 clinical trial reporting.

• Collaborate with the project team to ensure the deliverables are completed on time and with high quality.

• Create submission-ready standard data presentations and data sets using standard coding and following standard industry processes including SDLC.

• Maintain all project documentation as required by SOP and Processes

• Mentor statistical programmers

• Ensure compliance with eClinical Solutions and industry quality standards, guidelines, and procedures.

• Other duties as assigned. 

Education/ Language:

• Basic Science/Bachelor of Science degree (Master in Statistics or related science preferred) in health-related field, computer science or equivalent.

• SAS Certified 

• Excellent knowledge of English 

Professional Skills & Experience

• Minimum 6 years in Pharmaceutical/Biotechnology industry or equivalent IT consulting role

• Strong experience in preparations for NDA filings

• Strong knowledge of E6, E3, E9 guidelines, 21 CFR Part 11 and clinical trial methodologies 

• Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA)

• Knowledge of CDISC® related data models like SDTM, and ADAM.

• Experience of working on multiple clinical protocols at the same time.

• Excellent verbal and written communication skills

• Detail oriented, ability to multitask with strong prioritization, planning and organization skills. 

• Excellent team player

Technical Skills & Experience

• Experience of extracting, manipulating, merging, summarizing, analyzing, and presenting data using SAS procedures

• Strong experience of base SAS programming, Proc SQL, macro programming, ODS and various SAS modules: SAS/GRAPH, SAS/STAT and other modules like SAS/Connect and SAS/Access is a must.

• Experience with reporting environments and reporting tools related to SAS programming in pharmaceutical industry; proc report, proc summary and proc tabulate.

• Strong experience in SAS programming in various phases of clinical trial.

• Experience in pooled data analysis and programming. 

• Strong experience in efficacy reporting with regards to development of analysis sets and treating missing values.

• Experience in working with relational databases and performance tuning of SAS programming.

• Experience with writing batch scripts and/or shell scripts is a plus

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!

eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

Clinical Database Programmers are operationally responsible to provide technical support and oversight for the Medidata Clinical Cloud (MCC) implementation activities. Clinical Database Programmers will maintain project level perspective, focus and communicate effectively as the MCC SME on technical and functional electronic data capture programming and data management activities, timelines and deliverables. 

KEY TASKS & RESPONSIBILITIES 

• Design/develop and test clinical databases including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, custom functions, standard and custom reports
• Performs peer review for the studies built by other Clinical Database Programmers
• Responsible for the development, maintenance, and compliance of database builds and EDC standards in support of clinical studies including, but not limited to, Global Library, Edit Checks, CRF modules
• Manages timely-quality deliverables for the study teams for assigned protocol/study(s)
• Functions as an EDC Subject Matter Expert (SME) providing guidance and best practice recommendations to Data Management, operations teams, and other stakeholders on basic Medidata Rave functionality
• Working knowledge of additional Medidata Rave modules, including Coder, RTSM, Lab Admin, iMedidata/Cloud Admin or other modules.
• Other duties as assigned 

CANDIDATE’S PROFILE

Education & Experience

• Bachelor’s degree or equivalent work experience preferred
• 2+ years in Pharmaceutical/Biotechnology industry or equivalent preferred
• Experience with requirements gathering, design and specification development of CRFs, edit checks, site queries, and understanding of database structures and programming languages 

Professional Skills

• Ability to work creatively and independently to carry out assignments of a complex nature
• Ability to communicate and work effectively and cooperatively with other professional staff members
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills
• Excellent knowledge of English; verbal and written communication skills 

Technical Skills

• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
• Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology preferred
• Programming Languages: C#
• Expert knowledge of Medidata Clinical Cloud (MCC) especially Rave EDC capabilities and best practices
• Familiarity with Clinical Systems and technologies: ePRO, IVRS/IWRS, CTMS
• Experience with Data Reporting Tools: Business Objects, JReview, Cognos, Crystal Reports or related preferred

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. 

OVERVIEW

The Senior Software Developer will work closely with Product Manager, Implementation Consultants (ICs) and clients to gather requirements to meet the data analysis need of a company or a client. They must have good collaboration skills. The Senior Software Developer will provide direction on analytics aspects to the team on various analytics related activities.

KEY TASKS & RESPONSIBILITIES

• Experienced in Qlik Sense Architecture design and good knowledge on load script implementation and best practices.
• Hands on experience in Qlik Sense development, dashboarding, data-modelling and reporting techniques.
• Experienced in data integration through extracting, transforming, and loading (ETL) data from various sources.
• Good at Data transformation, the creation of QVD files and set analysis.
• Data Modelling using Dimensional Modelling, Star schema and Snowflake schema.
• Strong SQL skills (SQL Server) to validate the Qlik sense dashboards and to work on internal applications.
• Knowledge on deploying of Qlik Sense application using Qlik Management Console (QMC) is a plus.
• Work with Implementation consultants (ICs), product manager and clients to gather the requirements.
• Configuration, migration, and support of Qlik Sense applications.
• Thoughtful implementation of Qlik Sense best practices for efficiency and re-usability.
• Research and utilize new technologies.
• Collaborate with the Software Quality Assurance (SQA) team to test the applications functionality.
• Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures.
• Manage multiple timelines and deliverables (for single or multiple clients) and managing client communications as assigned.
• Other duties as assigned.

CANDIDATE’S PROFILE

Education/Language:

• Bachelor of Science / BTech / MTech / Master of Science degree in Computer Science and/or equivalent work experience
• Good verbal and written communication skills.

Professional Skills & Experience

• Minimum of 3 - 5 years of experience in implementing end to end business intelligence using Qlik Sense.
• Thorough experience in Qlik Sense architecture, design, develop, test and deployment process.
• Thorough understanding of Qlik Sense best practices (re-usability, efficiency, optimization).
• Knowledge on Clinical Datasets and Standards is a plus. (e.g.: SDTM, CDISC(92,45,101), Q Format, Customized Data formats .. etc.).
• Excellent understanding of relational database concepts, data modelling, and design.
• Excellent knowledge on writing SQL code and ETL procedures using MS-SQL Server.
• Strong Software Development Lifecycle experience (Agile methodology experience is a plus).
• Strong technical project management experience and team leadership skills including scope management, work planning and work delegation.
• Strong troubleshooting skills and use of defect/feature management systems.
• Proven ability to work independently and with technical team members (Startup environment experience is a plus).
• Good verbal and written communication skills.
• Strong analytical skills and strong decision-making capabilities.

Technical Skills & Experience

• 3+ years of experience in Qlik Sense architecture and design.
• 3+ years of experience in develop, test and deploy of Qlik Sense applications.
• 3+ years with SQL Server and ETL process.
• 3+ years with Data modeling (physical & logical).
• Experience with Performance tuning and best practices of Qlik Sense.
• Experience with Dimensional modeling, Star Schema and Snowflake Schema.
• Knowledge of clinical trial data and SDTM standards is a plus.

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!

eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

The Clinical Material Coordinator and SAP Process Owner is responsible for the business processes associated with inputting molecules into SAP, as well as movement of materials within internal clinical trial manufacturing sites and manufacturing at external collaboration partners. This includes the logistics associated with drug substance and drug product shipping, sample shipment and storage and raw material coordination. This role will support manufacturing across the Product Research and Development (PRD) Organization. The Material Coordinator will represent the Clinical Manufacturing organizations to streamline communications with Clinical Supply and Delivery and the supporting QA teams.

Clinical Material Coordinator Responsibilities:

• Establish SAP and Business processes to support material movements, both physically and within SAP and Quality Systems, for all PRD organizations.
• Maintain SAP data related to orders in support of the organization, this includes:
  • Establish new materials and purchasing information aligned with sourcing decisions
  • Create new vendor and customer numbers as needed
  • Establish Source List for triangulated sales products as needed
  • Accountable for MRP (Manufacturing Resource Planning) actions from the point of demand entry, purchase order creation through successful incoming receipt; reconciling any discrepancies be-tween goods receipt and contract partner invoice; completes business work center items to ensure all work is done and batch release
• Manage shipment of drug substance and samples to contract partners, warehouse, and testing facilities
• Own and optimize drug substance release huddle with development and QA to align on priorities, actions and approvals
• Communicate and work with Manufacturing Plant Planners on scheduling constraints and issues that require an adjustment to the plan in regard to drug substance availability and delivery, including drug substance representative at huddles
• Build strong relationships with development organizations through routine touch points
• Monitors delivery due dates and notify development or commercial teams when shipment of drug sub-stance is needed based on supply plan; ensures necessary import approvals are in place prior to shipment execution; creates outbound delivery if needed and performs goods issue in SAP as necessary
• Accountable for document exchange with the contract partner (e.g., ticket copies, CT packet, CoA's and other supporting documents regarding raw materials and components) and upload into internal system
• Coordinate activities and communicate timing on incoming and outgoing shipment schedules
• Upon completion of manufacturing order, performs SAP goods receipt; reconciles any discrepancies be-tween goods receipt and contract partner invoice; completes business work center items to ensure all work is complete
• Conducts periodic inventory reconciliations
• GMP Compliance
• Must be knowledgeable on how to apply GMPs in a clinical trial environment. Authors, reviews, and follow procedures applicable to the Clinical Trial business. In addition, individual training plans must be kept up to date
• Quality Assurance
  • Authors appropriate deviations (e.g., L1 temperature excursions, shipping, samples)
  • Participates in departmental site self-assessments and relevant audits

Requirements:

Skill Set:

• Excellent oral and written communication skills with the ability to interact well in a team environment
• Ability to develop/manage relationships with contract partners
• Ability to collaborate with partners around the world
• Initiative and ability to handle multiple projects in an independent fashion
• Excellent organization and self-management skills
• High initiative, flexible and positive attitude
• Ability to respond to changing priorities and short lead times

Technical:

• Experience with SAP
• Experience in managing inventory/supplies or complex supply chains
• Knowledge of clinical trial manufacturing operations
• Ability to use and apply multiple computer applications
• Ability to proactively identify problems and work toward a solution
• Minimum 1 year in a GMP environment

Education:

• Bachelor’s degree, preferably in health care or sciences related field or 10+ years’ work experience in supply chain or operations

Onsite job requirement in Indianapolis, IN.

How This Role Makes a Difference

PURPOSE

Be an integral part of the quality assurance and quality systems team by providing quality oversight and expertise to operations, manufacturing, and quality control activities. Address terms of product quality and conformance to regulations and Genezen quality policies/procedures. Help in the development of QA people and teams.

ESSENTIAL JOB FUNCTIONS / DUTIES

• Responsible for Quality Oversight of Manufacturing, Quality Control, and other areas as appropriate, through on the floor presence. Perform assessments during operations activities to ensure all work is performed in compliance with GMP, SOP and regulatory requirements
• Provide guidance to production employees with the intent to foster understanding and compliance with SOPs, GMPs and process improvements.
• Review cleanroom and supporting area documentation for accuracy and contemporaneous completion in batch records and logbooks
• Responsible for ensuring the Genezen documentation is compliant with cGMPs, GDPs, and consistent with other Genezen policies and procedures.
• Develop and optimize SOPs and other controlled documents for the Quality Assurance department.
• Review and approve SOPs and other controlled documents for the functional areas as the Quality representative.
• Review, approve and release critical raw materials for use in production and the quality control laboratories according to established specifications.
• Review, assess, and release quality control tests and Certificates of Analysis
• Review and approve executed batch records. Provide guidance and support to departments on errors to ensure error reduction.
• Assist in the final disposition of master cell banks and viral vector products.
• Review and approve qualification/validation protocols and reports and technology transfer reports.
• Provides site GMP and GDP training (annually, for new-hires, and as needed).
• Initiate and perform Root Cause Analysis for Quality Events such as Deviations and Environmental Excursions. This includes gathering data from various sources across the site (ex. Quality oversight, trend data, and training records), as well as performing interviews of personnel related to the Quality Events.
• Working cross-functionally with all departments to ensure Quality Events are thorough and accurate.
• Drive Quality Events to closure within on-time closure deadlines.
• Review and approve, and implement (as applicable) specifications for labels for media fills, master cell banks and viral vector products,
• Review and approve Master Batch Records.
• Review and approve Media Fill Protocols and Reports, as well as participate as a Quality observer as needed.
• Review and approve Stability Protocols.
• Initiate, review, and approve Corrective and Preventative Actions (CAPAs) and monitor CAPA effectiveness with collaboration from Operational areas
• Initiate, review, approve and monitor Change Management activities
• Work with the other functional areas to give guidance on use of quality systems.
• Assist the Lead Auditors to perform site internal audits.
• Lead and/or support customer audits and regulatory inspections by participating in either front or back room.
• Collaborate cross-functionally (e.g., Operations, Manufacturing, Regulatory, QC, other QA areas) to ensure product is manufactured according to approved procedures and complies with applicable regulations

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check and drug screen required
• Other duties as assigned

KNOWLEDGE, SKILLS & EXPERIENCE

PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Occasionally exposed to loud noise levels
• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail