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.

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. 

You will make an impact: 

The Sr. Corporate Counsel will report to the General Counsel and assist on all aspects of legal operations of the business with a primary focus on drafting, reviewing, negotiating and administering contractual documents that establish business relationships with customers, vendors, employees and partners. This position will work across the business globally partnering with all functional areas as well as external legal counsel and partners, and requires expertise to structure contracts, as well as analyze contracts to ensure compliance to company policy, government and industry specifications and other requirements. The Sr. Corporate Counsel will typically handle more complex legal matters, work with the larger clients, and be confident enough to make quick and accurate independent legal decisions.

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.  

Your day to day: 

• Overall responsibility for quickly reviewing the terms and conditions of all contracts to be the most advantageous from a legal and business perspective
• Draft, edit, standardize, and negotiate contracts, and proactively handle various transactional matters through to final signature including but not limited to NDAs, MSAs, SOWs, independent contractor agreements, vendor agreements, etc., with an emphasis on technology, SaaS, professional and biometric services
• Stay abreast of legal and regulatory developments affecting the company, its clients, and industries and synthesize the information to incorporate it into company’s transactional practices
• Contact for all functional areas and external partners to ensure all legal matters are addressed efficiently and promptly
• Work across time zones to support international colleagues and clients
• Develop, implement, and enforce contract management software for the request, prioritization, drafting, review, editing, execution, filing, reporting and compliance of contracts
• Train and educate others on various legal and compliance matters affecting the business, such as life sciences regulatory matters, AI, data privacy and security
• Make decisions within area of influence/responsibility, exercising independent judgment and viewed as an interdepartmental resource
• Research novel legal issues
• Maintenance and coordination of certain corporate records
• Assists on all other matters as needed

Take the first step towards your dream career. Here is what we are looking for in this role.  

Qualifications: 

• Juris Doctor (JD) degree
• In-house corporate law experience
• Professional experience in Technology, Software, Clinical Trial Development/Life Sciences
• Experience with AI regulations, data privacy law, employment law, intellectual property law, and corporate governance
• Ability to protect the company while keeping pace with the high speed of business
• Experience redlining and negotiating a variety contracts using the latest AI technology
• Familiarity with state, federal and international data privacy and security regulations
• Outstanding interpersonal skills and ability to communicate at all levels of organization in a high stress, fast paced environment
• Demonstrates ability to take initiative beyond direct responsibilities
• Must have excellent communication and writing skills
• Must have discretion and maintain confidentiality
• Demonstrates professional and positive demeanor and is perceived as highly competent
• Ability to complete high volume of work in a timely and thorough manner with minimal rework
• Ability to work well as part of a team and independently
• Must be well-organized, highly detail-oriented, and able to manage numerous projects, shifting priorities and conflicting demands in a fast-paced environment
• Strong time management, prioritization, project management and organizational skills
• The intellect and energy to excel in a complex and ever-changing environment
• High proficiency with computer systems and programs such as Microsoft Office, Adobe, Thomson Reuters Practical Law CoCounsel, LinkSquares contract management software, digital signature software, research tools, etc.

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 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. 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.

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 Principals Biostatisticians will work closely with clients and provide high level consulting services for statistical analysis, reporting, and statistical programming specific activities which may include development of statistics section of protocol, development of statistical analysis plan, randomization schedule, conducting statistical analyses, validating programming and reporting output, and developing statistical analysis report. Principal Biostatisticians will also work on statistical programming for development of analysis datasets, and clinical tables, listings, and graphs specific to trial reporting requirements. Principal Biostatisticians will work as needed assuring that all client work has met or exceeded client expectations.

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.  

Your day to day: 

• Provide consulting of statistics activities related to clinical trials. Fulfill the responsibilities of study statistician as required
• Provide mentoring and QC of statistical programmer’s outputs; define analysis data specifications. If required, validate the statistical models used for programming
• Act as study statistician - interact with client and with clinical team including programmers, clinical data managers, clinical protocol manager, and other relevant personnel. Ensure that programmers get correct specifications and data at appropriate time
• Develop, review, and finalize the statistical analysis plan
• Validate the programming deliverables and collaborate with applicable team members to rectify any issues related to statistical reporting and analysis
• Develop randomization schedule, specifications, and guidelines
• Wherever applicable, provide input in finalization of study specific data quality control plan and ensure appropriate data analysis and reporting
• Wherever applicable, develop, validate and finalize the study specific list of table and table shells for clinical study reports and for study specific deliverables
• Ensure that all comments from the clinical team with regards to statistical report delivered for study specific deliverables are being addressed appropriately
• Analyze the data and contribute to trial progression related decisions by providing necessary input during trial specific deliverables including but not limited to blinded data reviews, and interim analyses
• Collaborate with team members for regulatory reviews, representations, and supporting data analyses including the study or compound level exploratory analyses, ad-hoc analyses, and post- hoc analyses
• Develop SAS programs to generate analysis datasets, and trial specific reporting including but not limited to tables, listings, graphs, queries, and patient profile reports
• Ensure compliance with eClinical Solutions and industry quality standards, guidelines and procedures
• Other duties as assigned

Take the first step towards your dream career. Here is what we are looking for in this role.  

Qualifications: 

• Master in Statistics or biostatistics preferred
• SAS® certification is preferred
• 10+ years in Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming role preferred
• Strong experience with clinical study design development, analysis, and sample size determination
• Experience with development of randomization schedule including development of IVRS specifications, and guidelines for appropriate usage of randomization schedule
• Excellent knowledge of English and with clear, concise, and accurate communications, both written and verbal 
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills
• Ability and experience of delegating tasks and leading projects. Experience of working on multiple clinical protocols at the same time
• Ability to balance conflicting priorities
• Strong knowledge of ICH guidelines and other guidelines such as GCP, and 21 CFR Part 11 from different regulatory agencies including FDA, and EMEA
• Experience in developing statistical analyses reports, and in conducting statistical analyses and reporting for various trial level deliverables including but not limited to blinded data reviews, interim analyses
• Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) and clinical reporting processes
• Knowledge of CDISC® related data models such as SDTM, and ADAM. Ability to develop ADAM model for analysis and reporting of clinical trial. Through understanding of SDTM data structures

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 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. 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.

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. 

You will make an impact: 

The Principal Data Engineer 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 Principal Data Engineer 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. 

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.  

Your day to day: 

• 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

Take the first step towards your dream career. Here is what we are looking for in this role.  

Qualifications: 

• 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  

• 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 

• 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  

• Excellent 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 

• Proficient in SQL, T-SQL, PL/SQL programming  

• 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  

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 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. 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.

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

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 is a global leader in clinical data intelligence, delivering the elluminate® Clinical Data Cloud® — an AI-powered platform driving agentic data review, SDTM automation, and RBQM for 18 of the top 50 pharmaceutical companies worldwide.

As part of our eNOVA AI-First transformation, we are embedding AI across every pillar of clinical development and enterprise operations — compressing cycle times, improving data quality, and redefining how work gets done.

As we scale our AI capabilities, we are building a high-impact, hands-on AI engineering function focused on delivering real, production-grade automation across the enterprise.

You will make an impact:

The Principal AI Engineer – Automation & AI is a hands-on technical leader responsible for designing, building, and deploying AI-powered automation solutions across eClinical Solutions.

This role is builder-first (70–80% hands-on development) and operates within a small, high-output team (2–4 engineers). You will work directly with the CTAO and business leaders to identify high-value use cases and rapidly translate them into working AI systems in production.

This is not a program management or oversight role. You are expected to build, ship, and iterate continuously, leveraging modern AI tooling and agentic frameworks to deliver measurable impact.

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.

Your day to day:

Building & Shipping AI Systems

• Design and deploy agentic AI workflows and automation solutions across enterprise functions including R&D, Engineering, Professional Services, IT, Finance, Sales, and Marketing
• Build production-grade systems such as:
• Multi-agent workflows
• RAG-based applications
• Document intelligence and summarization pipelines
• Workflow and process automation solutions
• Use modern AI tools and frameworks including:
• Codex, Claude Code, Gemini, NotebookLM
• LangChain, LangGraph, LlamaIndex (or equivalents)
• Rapidly prototype, validate, and deploy solutions in weeks, not months

Owning End-to-End Delivery

• Translate business problems into working AI systems
• Design lightweight architectures and iterate quickly
• Develop and implement:
• Prompt engineering strategies
• Orchestration logic
• API integrations and data pipelines
• Testing, validation, and monitoring frameworks
• Partner directly with stakeholders to refine outputs and drive adoption

Driving High-Velocity Execution

• Deliver continuous output with weekly or bi-weekly releases
• Prioritize use cases based on:
• ROI and business impact
• Technical feasibility
• Speed to value
• Operate with minimal process and high accountability in a fast-paced environment

Contributing to Scalable AI Foundations

• Build and maintain reusable assets including:
• Prompt templates
• Agent design patterns
• Integration utilities
• Contribute to lightweight standards for:
• Security and data handling
• Responsible AI practices
• Evaluation and performance monitoring

Technical Leadership & Mentorship

• Provide technical guidance to a small team of AI engineers and automation specialists
• Lead by example through hands-on contribution
• Support the evolution of the AI engineering function as it scales

Take the first step towards your dream career. Here is what we are looking for in this role.

Qualifications: 

• Bachelor’s degree in Computer Science, Engineering, Data Science, or a related technical field
• 6–10+ years of software engineering experience with recent hands-on work in AI/LLM systems
• Proven experience building and deploying:
• LLM-powered applications
• Agentic workflows
• Automation solutions in production environments
• Strong hands-on experience with tools such as:
• Codex, Claude Code, Gemini, NotebookLM (or similar AI-assisted development tools)
• LangChain, LangGraph, LlamaIndex, or equivalent frameworks
• Proficiency in:
• Python
• API development and system integration
• Cloud platforms (AWS, Azure, or GCP)

Preferred

• Experience with:
• RAG architectures and vector databases
• AI evaluation frameworks, guardrails, and monitoring
• Workflow automation tools and enterprise integrations
• Experience working in regulated environments (e.g., life sciences, healthcare, financial services)
• Familiarity with clinical data, CDISC standards, or clinical development workflows
• Experience in high-growth or PE-backed SaaS environments

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 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. 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.

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. 

eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions. 

You will make an impact:   

As a Senior Portfolio Lead, you will be responsible for strategic oversight for assigned customers and ensuring consistency of Data Management services across a customer’s program. You will be responsible for setting data standards, establishing process improvement and process workflows along with designing optimized clinical data flows across numerous systems and taking part in technology improvement and implementation efforts. You will manage end-to-end delivery of data management services for portfolio projects, ensuring quality deliverables on time and within budget, to customer satisfaction. 

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.  

Your day to day: 

• Manage Data Management related aspects of a customer’s program. Provide proactive consultative advice and guidance on overall data management approach and strategy 
• Responsible for strategic oversight of assigned customers 
• Serve as the customer’s Subject Matter Expert (SME) on Data Management topics and strategies 
• Collaborate with the study project team on overall data management strategy for a customer’s program of studies, assuring overall quality and efficiency 
• Work with study project team members and project managers with project level scope management as appropriate 
• Provide proactive, timely communication of customer’s program status, data trends and issue resolution with internal team and customers 
• Perform peer reviews of key Data Management study documents or other Data Management deliverables to assure quality of content and, where appropriate, consistency across a customer’s program of studies 
• Provide training of Data Management staff on customer’s processes 
• Act as an escalation path for internal teams in relation to a customer’s program challenges or issues 
• Participate in the development and implementation of new customer technologies or tools 
• Map and assess current customer processes and structures for data strategy and identify gaps and areas for improvement 
• Lead cross-functional project teams to map out data needs; advise customers on relevant data, champions data appropriateness and communicate the opportunities and challenges 
• Apply data-driven methods to make informed decisions about solutions, deliveries, and teams 
• Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation 
• Ability to take risks implementing innovative solutions, accelerating value to customers 
• Ability to identify areas for process and systems innovation and implement changes that will enhance the overall effectiveness of the team 
• Ability to work in a global and highly matrixed ecosystem (internal and external) with a high degree of complexity 

Take the first step towards your dream career. Here is what we are looking for in this role.  

Qualifications: 

• Bachelor of Science degree (Master’s in Science preferred) in health-related field preferred 
• 10+ years working in the Life Sciences industry, preferably with extensive experience supporting Pharmaceutical/Biotechnology/Medical Device organizations in a consultative role with a demonstrated successful record of accomplishment of delivering quality and value to clinical teams preferred 
• Able to proactively make recommendations that optimize clinical data flow and data collection designs as well as identify leading indicators of quality issues and act upon identified clinical data trends 
• Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology 
• Strong project management skills a history of successful scope management, resource management, financial management, project planning and resource allocation 
• Strong client focus with proven experience delivering solutions requiring managing complex client relationships, multiple Data Management services and delivering results that exceed customer expectations for service and operational excellence 
• Extensive experience with data review and analytics applications 
• Strong understanding of Data Management concepts with an ability to implement modern decentralized trials 
• A detail-oriented team player with strong organizational skills and the ability to multi-task, prioritize and plan within a high-energy, solutions-based environment where the customer comes first 
• Intellectual curiosity about the science of drug development and how data can best support the scientific goals of a clinical program and how to champion data throughout the clinical development process 
• Excellent writing and communication skills with proven experience presenting complex ideas clearly and concisely 

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 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. 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.

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. 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

About eClinical Solutions

eClinical Solutions is transforming clinical development with elluminate®, our Clinical Data Cloud, helping life sciences organizations unify, analyze, and unlock the value of their data faster than ever before. By combining a modern cloud platform with expert data services, we empower smarter decisions across the clinical trial lifecycle—accelerating innovation that ultimately improves patient outcomes.

Our engineering teams build enterprise-grade, revenue-generating products at the intersection of cloud, data, analytics, and emerging AI technologies. If you’re excited about building sophisticated software that makes a real-world impact on healthcare, this is the place to do it.

You will make an impact: 

As a Principal Full Stack Software Engineer, you will be a technical leader within the elluminate Product Development team. You’ll help design and build the core services and user experiences of a next-generation clinical data and analytics platform—while influencing architecture, engineering standards, and technical direction.

This role is ideal for an experienced engineer who enjoys hands-on development, mentoring others, and bringing modern capabilities—including AI-assisted and agentic workflows—into production-grade systems.

Your day to day: 

• Design, develop, test, and deploy scalable, secure, and highly interactive web applications
• Own and evolve core platform modules, from concept through release and support
• Influence application and system architecture with a focus on performance, reliability, security, and maintainability
• Lead by example through clean, well-tested code, thoughtful design reviews, and pragmatic technical decisions
• Collaborate closely with Product Management, QA, and other engineers throughout the SDLC
• Provide technical mentorship and guidance to other engineers on the team
• Diagnoses and resolves complex production issues across distributed systems
• Ensure solutions meet eClinical Solutions quality standards and applicable industry regulations
• Contribute to technical documentation including design specs, acceptance criteria, and release notes

AI & Modern Engineering Focus

We’re actively incorporating AI-powered capabilities into our platform, and you’ll help shape how this is done responsibly and effectively in an enterprise environment. This includes:

• Integrating LLMs and AI services into .NET- and Python-based systems
• Designing and implementing AI-assisted workflows, copilots, or intelligent automation features
• Working with agentic AI patterns (e.g., task orchestration, tool-using agents, workflow automation)
• Applying prompt engineering, evaluation techniques, and guardrails to ensure reliability and compliance
• Collaborating with data and platform teams to operationalize AI—not just prototype it

Deep ML expertise is not required—we’re looking for strong engineers who understand how to apply AI capabilities in real products.

Take the first step toward your dream career.  Here is what we are looking for in this role. 

 Qualifications:

• Bachelor’s or Master’s degree in Computer Science or equivalent practical experience 
• 10+ years in software design and development using the Microsoft technology stack preferred 
• Expert-level proficiency in C#, .NET, and ASP.NET (MVC/Web APIs)
• Strong experience building full-stack web applications (Angular, TypeScript, HTML, CSS)
• Solid understanding of software design principles, patterns, and best practices
• Experience across the full Software Development Lifecycle (Agile preferred)
• Proven ability to work independently while collaborating effectively in a fast-paced environment
• Excellent communication, documentation, and technical leadership skills

AI & Platform Experience

• Hands-on experience integrating LLM-based services (e.g., OpenAI, Azure OpenAI, or similar) into applications
• Experience using Python and/or .NET alongside AI/LLM workflows
• Familiarity with agent-based or workflow-driven AI architectures is a strong plus
• Understanding of secure and responsible AI usage in enterprise systems

Nice to Have

• Strong SQL expertise (Microsoft SQL Server preferred), including performance tuning
• Experience with microservices, distributed systems, and cloud platforms (AWS preferred)
• Secure development experience, including awareness of common vulnerabilities and mitigations
• Experience with clinical trial data, life sciences, or regulated SaaS environments
• Experience building data visualizations or analytics-driven user experiences

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 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. 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.

#LI-AB1

OVERVIEW

The Executive Assistant provides high quality administrative, operational, and communication support to the Senior Leadership Team (SLT). The SLT is primarily located in the United States and the role requires strong coordination across time zones, disciplined follow through, and the ability to manage sensitive information with complete confidentiality. This position is central to ensuring the effectiveness, efficiency, and rhythm of the leadership team.       

KEY TASKS & RESPONSIBILITIES

Executive Support 

• Manage complex, high-volume calendars for SLT members. 
• Coordinate meetings, logistics, and travel across US and India time zones. 
• Prepare agendas, briefing materials, and post-meeting action summaries.

Operational Coordination 

• Track deliverables, deadlines, and follow ups for SLT commitments. 
• Coordinate quarterly business reviews, offsites, and global leadership meetings. 

Communication and Documentation 

• Draft and edit executive level communications and presentations. 
• Maintain the highest level of confidentiality with all information accessed. 
• Facilitate timely information flow between India based teams and US based SLT. 

Process and Systems Management

• Maintain org charts, shared drives, distribution lists, and leadership documentation. 
• Improve administrative processes by adopting modern productivity and AI tools. 
• Support onboarding and coordination activities for new leaders. 

Stakeholder Interaction 

• Engage professionally with internal leaders, clients, and external partners. 
• Represent the SLT with responsiveness, clarity, and professionalism. 

Education & Experience

• 8 to 10 years of experience supporting senior executives in global or fast paced environments preferred. 
• Strong written and verbal communication skills. 
• Expert level proficiency in Microsoft 365, Teams, Zoom, and related tools. 
• Proven ability to work effectively across time zones with flexible hours when needed. 
• Strong organizational discipline and attention to detail. 
• Demonstrated ability to handle confidential information with discretion. 

Preferred Qualifications 

• Experience working in life sciences, technology, or global enterprise environments preferred. 
• Prior experience supporting US based executives. 
• Comfort with AI enabled productivity tools and modern workflow automation. 
• Basic project coordination experience. 

Key Competencies

• Professional presence 
• High ownership and reliability 
• Strong judgment and problem solving 
• Proactive planning and follow through 
• Adaptability in a global, fast-moving environment 

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. 

eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions. 

You will make an impact: 

As a Senior Clinical Data Manager (Sr. CDM) you will independently act as a study lead and are responsible for the oversight, maintenance, and management of clinical trial database(s) for assigned projects through the full data management process life cycle. You are viewed as the CDM expert and will serve as the primary liaison between eClinical personnel and Sponsor personnel. You will create and oversee the database design specifications, validation, maintenance/data cleaning, and closeout activities of project-specific clinical trial databases. As a Senior Clinical Data Manager, you may delegate tasks/responsibilities to multiple team members in multiple projects. You will provide ongoing project oversight to ensure proper planning and timely completion of high-quality Sponsor deliverables. 

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. 

Your day to day: 

• Primary representative for eClinical Solutions and sponsor data management interaction
• Responsible for monitoring and ensuring adherence to study timelines and deliverables 
• Accountable for the overall quality of data management activities and deliverables at the study or program level 
• Ensure efficiency and consistency for data management tasks across programs 
• Communicate with global study teams 
• Participate in client study kickoff and closeout/lessons learned meetings 
• Create materials for and present at Investigator Meetings 
• Develop content and deliver Sponsor CRA and/or site training 
• Delegate tasks, support and provide guidance to study data management team 
• Oversee and/or develop data management documents including DMPs, eCRF Completion Guidelines, CRFs, and Help Text 
• Oversee and/or Develop Internal System Testing (IST) plan for database/user roles/edit check specifications 
• Participate in Internal System Testing (IST) on the database/user roles/edit check specifications 
• Assist with preparation for implementation of a centralized data management platform for strategic data cleaning and reporting 
• Utilization of centralized data management platform including graphical patient profiles and operational analytics 
• Compile the sponsor UAT package 
• Oversee and/or perform data review as documented in the Data Management Plan and Data Validation Specifications 
• Oversee and/or perform manual review/QC checks as listed in the Data Validation Specifications exception listings and reporting tools 
• Oversee and/or perform data review for overall consistency and accuracy 
• Oversee and/or perform vendor data reconciliation (e.g., IVRS, laboratory data) with the clinical database 
• Oversee and/or perform query processing/resolution 
• Provide ongoing data management reports and metrics 
• Oversee and/or develop specifications and collaborate with programming for programming and QC of manual listings, external data reconciliation, metrics and custom reports as needed throughout the study 
• Define and develop specifications for database, programming and/or edit check changes as needed throughout the study 
• Track data management issues and ensure follow up to resolution 
• Identify data issues and/or data trends, communicate to the Clinical Data Management team and Sponsor, assist with development and implementation of action plan 
• Maintain data management study documentation 
• Perform steps pertaining to database freeze/lock and coordinate all related activities 
• Ongoing evaluation of process and participate in process improvement 
• Assist in the creation and review of SOPs, WIs, and training materials 
• Mentor junior level staff and peers on all associated tasks within a study 
• Participate in proposal defenses 
• Perform other duties as requested by management 

Take the first step towards your dream career. Here is what we are looking for in this role. 

Qualifications: 

• Bachelor’s degree in Pharmaceutical/Biotechnology or higher in health-related field preferred 
• 8+ years in Clinical Data Management experience preferred  
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology 
• Strong project management experience and project team leadership skills including work planning and work delegation 
• Experience with EDC and performing data management activities 
• Excellent verbal and written communication skills 
• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel 
• Experience with EDC and Clinical Data Management Systems  

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 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. 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.

Senior DevOps Software Engineer

eClinical Solutions is transforming clinical development with elluminate®, our Clinical Data Cloud, helping life sciences organizations unify, analyze, and unlock the value of their data faster than ever before. By combining a modern cloud platform with expert data services, we empower smarter decisions across the clinical trial lifecycle—accelerating innovation that ultimately improves patient outcomes.

Our engineering teams build enterprise-grade, revenue-generating products at the intersection of cloud, data, analytics, and emerging AI technologies. If you’re excited about building sophisticated software that makes a real-world impact in healthcare, this is the place to do it.

You will make an impact:

As a Senior DevOps Software Engineer, you will serve as a technical leader within the product development organization. You will be responsible for designing and architecting AWS-based infrastructure that powers a reliable, scalable, secure, high-performing Clinical Data Intelligence Platform as well as operationalizing AI/ML capabilities across the platform and engineering team.  

You will drive infrastructure design and implementation from the ground up, building fully automated testing and code delivery mechanisms with minimal manual intervention. The environment requires strong SDLC traceability, governance, and controlled promotion of software artifacts across environments. 

In this role, you will influence engineering standards, infrastructure strategy, and technical direction across teams. You will collaborate closely with experienced engineers and leverage tools such as Bitbucket, TeamCity, Octopus Deploy, and Jira to enable automated CI/CD pipelines, artifact traceability, and controlled releases. 

This role is ideal for an experienced, self-driven engineer who enjoys hands-on architecture, mentoring others, and introducing modern capabilities—including AI-assisted and agentic workflows—into production-grade systems. 

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.

Your day to day:

• Design, develop, test, and deploy scalable, secure, and highly interactive web applications
• Own and evolve core platform modules, from concept through release and support
• Influence application and system architecture with a focus on performance, reliability, security, and maintainability
• Lead by example through clean, well-tested code, thoughtful design reviews, and pragmatic technical decisions
• Collaborate closely with Product Management, QA, and other engineers throughout the SDLC
• Provide technical mentorship and guidance to other engineers on the team
• Diagnoses and resolves complex production issues across distributed systems
• Ensure solutions meet eClinical Solutions quality standards and applicable industry regulations
• Contribute to technical documentation including design specs, acceptance criteria, and release notes

 Take the first step towards your dream career. Here is what we are looking for in this role.

Qualifications: 

• Bachelor’s degree or higher preferred (Computer Science, Data Science, Engineering, or related field) and/or equivalent work experience preferred
• 10+ years of hands-on enterprise software engineering experience in scalable production environments preferred
• 8+ years of practical AWS experience preferred
• Experience managing and operating SaaS platforms on Kubernetes (EKS) and ECS, including container build, deployment, lifecycle management, scaling, and troubleshooting
• Proven experience fully automating software release processes, scaling from infrequent releases to continuous delivery with multiple daily deployments, including automated rollback based on test validation.
• Implement and support MLOps pipelines for model training, validation, deployment, monitoring, and retraining.
• Strong experience designing and implementing Infrastructure as Code using Terraform and CloudFormation
• Advanced scripting experience (Python, PowerShell, Bash) for automation and platform tooling
• Responsible for end-to-end support of automated test execution within CI/CD pipelines using TeamCity and Octopus Deploy, including test orchestration, environment provisioning, parallel execution optimization, reporting, and enforcement of quality gates
• Maintain integration with Bitbucket for source control and pull request workflows, and Jira for automated traceability between code changes, builds, deployments, and work items
• Strong experience with application monitoring and observability using CloudWatch, Datadog, and/or New Relic
• Experience with building infrastructure prepared to meet rigorous Disaster Recovery requirements
• Strong analytical and problem-solving skills
• Excellent planning, coordination, and organizational skills
• AWS:
  • Networking - VPC, subnets, route tables, NAT, ALB/NLB, Route 53)
  • Compute - EC2, Auto Scaling, Lambda, ECS, EKS)
  • Storage - S3, EBS, EFS, FSx)
  • Security - Solid understanding of security and compliance principles, including IAM, WAF, encryption (KMS), and integration of SAST, SCA, and DAST into CI/CD pipelines
• Programming/Scripting: Python, PowerShell, bash, SQL, .NET
• DevOps Tools: TeamCity, Octopus Deploy, Git-based workflows
• Containerization & Orchestration: Docker, Kubernetes and AWS EKS and ECS
• Infrastructure as Code: Terraform or equivalent
• Databases: SQL Server or equivalent
• AI/ML Frameworks: TensorFlow, PyTorch, scikit-learn (preferred)
• MLOps Tools: MLflow or equivalent
• Monitoring & Observability tools: DataDog, NewRelic

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 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. 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.

#LI-AB1

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.

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. 

You will make an impact:   

As the Senior Technical Project Manager, you will be responsible for ensuring the delivery of quality products and services to eClinical Solutions’ clients and partners. You will oversee the successful delivery of eClinical Solutions’ elluminate product, a next generation data integration and analytics cloud platform that enables life sciences organizations to optimize the aggregation, standardization, and analysis of their data throughout the clinical development lifecycle. You will develop roadmaps and timelines for executing the highest quality of technical services and support including but not limited to solution integration, custom reporting, data mapping and Clinical Data Repository. You are responsible for developing and maintaining detailed project documentation, managing client expectations and approvals on scoped deliverables, balancing and reconciling the project budget, serving as the point person for project communication and issue escalation, effectively realigning resources in response to scope changes and proactively mitigating other potential risks, fostering positive and long-lasting client relationships, driving elluminate utilization, and driving project efforts toward successful (on time, on budget, within scope) completion.  

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.  

Your day to day: 

• Independently lead and drive elluminate implementation projects throughout the project lifecycle by consistently using PMI-compliant and eClinical Solutions-required methodologies, standards, and best practices 
• Successfully manage multiple software implementation projects simultaneously, ensuring that proper documentation is developed and maintained, that project risks are mitigated with a collaborative team approach and that client satisfaction remains at the forefront of all efforts 
• Collaborate with internal and external subject matter experts to deliver seamless elluminate integration, rapid system adoption and end-user utilization, and the highest quality of professional services to our clients 

Take the first step towards your dream career. Here is what we are looking for in this role.  

Qualifications: 

• Bachelor's degree preferred, in a health sciences or analytic discipline  
• 5+ years of systems/software project management experience in a clinical, biomedical, or software environment 
• Clinical data management experience preferred 
• Exceptional multi-tasking and time management skills, including the ability to effectively resource competing priorities and adapt to changing client demands 
• Excellent written and verbal communication skills and an ability to effectively partner with audiences at all levels of the eClinical Solutions and client organizations 
• Commitment to utilizing operational standards, PMI methodologies and best practices with a focus on process efficiencies and revenue growth opportunities 
• Proficient with Microsoft applications (Word, Outlook, Excel, PowerPoint, Project, Visio, Teams, etc.) and collaborative platforms like MS Teams, OneDrive, and SharePoint 
• Experience managing client projects that focus on technical deployments, system implementations, and/or data management and reporting 
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trials methodology, CRO partnerships, and EDC systems (Medidata, Rave)  

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 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. 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.

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.

OVERVIEW

The Marketing Manager will lead eClinical Solutions’ marketing efforts in the India region, focused on building brand awareness, amplifying employer brand visibility, and strengthening thought leadership in the local marketplace. This role will ensure eClinical Solutions is recognized as an employer of choice for top life sciences talent and as an innovation leader among the India-based community of global pharma and CRO professionals.

The Marketing Manager will be responsible for the planning, execution, and reporting of internal and external marketing initiatives across India, including events, communications, and local brand activations. The Marketing Manager will collaborate closely with the global marketing organization to ensure alignment with the global brand strategy, while driving independent initiatives tailored to India’s priorities.

Approximately half of this role will also contribute to global marketing initiatives, including market research, competitive analysis, and strategic projects that inform global campaigns and positioning. This dual focus ensures the Marketing Manager plays a key role in both regional success and global growth.

This position acts as the central connector between global marketing and India operations, ensuring consistent brand storytelling, strong internal engagement, and strategic visibility in the India ecosystem.

KEY TASKS & RESPONSIBILITIES 

CANDIDATE’S PROFILE

Education & Experience

• Bachelor’s degree in marketing, Communications, or related field preferred.
• 7+ years of experience in marketing, in B2B SaaS or Life Sciences/Healthcare industries preferred.
• Experience in corporate branding, employer branding, or regional marketing management preferred. 

Professional Skills 

• Strong project manager with hands-on experience planning and executing events and campaigns.
• Excellent collaborator and communicator with ability to work across time zones and functions.
• Highly organized, detail-oriented, and comfortable managing multiple priorities.
• Analytical mindset and able to measure and communicate marketing impact clearly.

Technical Skills & Experience 

• Proficiency in Microsoft Office programs.
• Experience with Salesforce and HubSpot preferred.

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.