Electronic Data Capture (EDC) Manager

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 Responsibilities

EDC 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 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.

Qualifications

Education: 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.