Title:Electronic Data Capture (EDC) Development & Operations Manager
Location:The position will be based in Princeton NJ. 2 days per week in office required. Must be local to Princeton. Resumes without a location will not be acknowledged.
Reports To:Director, Enroll-HD 2.0 Planning & Implementation
Salary Range:$80,000-$150,000. Exact compensation will vary based on experience
Other:Vaccination against COVID-19 is a prerequisite for employment at CHDI Management
Job Description:This role is responsible for the strategic oversight, planning, development, and execution of EDC study builds and related clinical systems initiatives. This role leads end-to-end database development, manages EDC vendors and concurrent projects, establishes priorities and resource plans, and ensures systems meet protocol, quality, regulatory, and organizational requirements.
The EDC is a highly customized system that integrates multiple functionalities. At its core, it is a standard data entry tool, but it also delivers multiple study workflows including but not limited to: Source Data Verification (SDV/Monitoring), site payments, and real-time reporting, biokit ordering and biosample shipment tracking. The position provides functional leadership to systems administration and EDC support staff and may assume direct people-management responsibilities as the team grows.
Key ResponsibilitiesEDC Database Development and Lifecycle Management- Lead end-to-end EDC study builds, including requirements gathering, design, configuration, testing, validation, deployment, maintenance, amendments, and database lock support.
- Translate study protocols into technical specifications for but not limited to eCRFs, visit schedules, edit checks, dynamics, derivations, workflows, user roles, and permissions.
- Configure and maintain study databases in sponsor-supported EDC platforms, ensuring alignment with protocol requirements, sponsor standards, data collection best practices, and applicable data standards.
- Manage database releases, version control, change documentation, production migration, and mid-study updates.
- Support external data integrations, including central laboratories, eCOA/ePRO, imaging systems, wearables, and other digital health technologies; review transfer specifications and reconciliation requirements.
Testing, Quality, and Compliance- Test the EDC database to ensure it functions as designed, meets documented requirements, and is approved by study teams before production use.
- Track, document, investigate, and resolve system defects and production issues.
- Ensure EDC systems and study databases comply with GCP, 21 CFR Part 11, internal SOPs, quality standards, and other applicable regulatory requirements.
Project, Portfolio, and Resource Management- Manage multiple concurrent projects and sub-projects, including initiatives that intersect with EDC system and vendor deliverables.
- Develop and maintain project plans, timelines, dependencies, risks, mitigation strategies, and status reporting.
- Develop and maintain SOPs, work instructions, process documentation, standards, and training materials.
- Drive cross-functional execution to meet study milestones, quality expectations, and database delivery timelines.
- Evaluate and prioritize requests for builds, enhancements, integrations, and vendor support based on portfolio needs, feasibility, capacity, and organizational strategy.
- Provide recommendations on sequencing, resourcing, trade-offs, risks, and decision options.
Vendor and Technology Oversight- Serve as the primary operational contact for EDC vendors and technology partners.
- Oversee vendor performance, deliverables, timelines, quality, budgets, and contractual alignment.
- Review and approve statements of work, level-of-effort requests, technical recommendations, and cost estimates for EDC-related initiatives.
Leadership and Cross-Functional Collaboration- Provide functional leadership to systems administration and EDC support staff, including work allocation, prioritization, mentoring, and technical guidance.
- Identify capability gaps and support training and development plans that build sustainable internal EDC and clinical systems expertise.
- Partner with Clinical Operations, Data Management, Biostatistics, IT, Medical Monitoring, Study Management, and external vendors to deliver study objectives.
- Communicate status, risks, dependencies, and decisions clearly to technical and nontechnical stakeholders.
QualificationsEducation- Bachelor's degree in life sciences, health sciences, information systems, computer science, or a related discipline.
Experience- At least 5 years of experience in clinical data management, clinical systems, or a related function within a biotechnology, pharmaceutical, CRO, or clinical research environment.
- At least 3-5 years of hands-on EDC database build experience, including independent configuration and maintenance of study databases.
- Experience supporting clinical studies from startup through database lock, including protocol amendments and mid-study database updates.
- Demonstrated experience managing multiple projects, external vendors, competing priorities, and cross-functional stakeholders.
- Prior team leadership, mentoring, or people-management experience is preferred.
Technical Knowledge and Skills- Experience with one or more EDC platforms.
- Strong knowledge of EDC database development lifecycles, eCRF design, edit checks, study workflows, testing, release management, and change control.
- Working knowledge of GCP, 21 CFR Part 11, CDASH, CDISC, computer system validation, and clinical data standards.
- Strong analytical, organizational, problem-solving, communication, and stakeholder-management skills.
- Ability to translate protocols and business needs into practical technical solutions while balancing quality, timelines, cost, and operational risk.
