Job Description

Position Summary:

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

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

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

Qualifications:

Minimum Required:

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

Other Required:

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

Preferred:

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

Skills:

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

Position Summary:

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

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

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

Qualifications:

Minimum Required:

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

Position Summary:

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

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

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

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

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

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

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

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

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

Qualifications: 

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

Other Required:

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

Preferred:

• CRO experience as a Clinical Data Engineer or Programmer

Skills:

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

Competencies

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

Position Summary:

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

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

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

 Qualifications:

Minimum Required:

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

Other Required:

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

Preferred:

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

Skills:

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

 Competencies:

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

Position Description: 

Precision for Medicine develops assays and runs global logistics by using biomarkers to stratify patients, incomparably improving R&D efficiency and success for our clients. We lead every aspect of clinical trials from sites to biomarkers to diagnostics, all under a single roof. We dramatically accelerate our clients' pathway from proof of concept to drug approval.         

Qualifications:

• Education: Bachelor’s degree or equivalent desired.  Degree in computer science or related fields preferred.

Work Experience:

• 6+ years of experience in solutioning and delivering software products/solutions including experience in planning and execution. 
• 3+ years of experience in leading the development and implementation of business initiatives and products/projects.
• Proven experience building and delivering high scale, secure platforms (custom developed and off the shelf)
• Experience with cloud-hosted technologies and cloud services (Azure, AWS S3 bucket, Google, Log management of the application like ELK)
• Experience working with a team following Agile software development lifecycle practices
• Experience with debugging tools like developer tools, SQL profiler etc.,
• Experience working with various tools, open-source technologies, and cloud services
• Experience of the following tools and technologies: Angular, DevExpress, SQL Server, ASP.Net C#, Windows, DACPAC, HTML, CSS, JavaScript, jQuery, SSIS and .net core api,
• Experience with Web-Based Development Frameworks such as ASP.NET, WebForms, MVC, Angular, React, Node.js
• Experience working with BitBucket, GitLab, Azure DevOps, Jira, or similar systems for software development
• Lifecycle management, source control, branching, and/or CI/CD pipelines
• Expert with database concepts, data modeling, and data management and optimizing the SQL queries and stored procedures

Skills:

• Ability to drive, contribute, and support the execution of department vision.
• Evangelist for innovation and continuous improvement. Must be able to influence technical and non-technical executives and senior leaders.
• Ability to solve highly complex product issues through technical insight and collaboration with companywide and/or industry peers.
• Deep understanding of business strategy and ability to translate strategy into system and technology solutions.
• Excellent organizational, interpersonal, communication, and presentation skills, must be detail-oriented.
• Ability to create and foster relationships within a team-oriented, collaborative environment leveraging excellent communication skills.
• Ability to quickly learn and adapt to new business processes and technologies
• In-depth knowledge and hands-on experience with all phases of an SDLC.
• Excellent application documentation skills and ability to create architecture diagrams and roadmaps
• Solid understanding of Agile software development principles.