Electronic Data Capture (EDC) Manager

CHDI Management•Princeton, NJ

9d•$80,000 - $150,000•Hybrid

About The Position

This role provides strategic oversight for planning, developing, and executing EDC study builds and related clinical systems initiatives. It 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 highly customized EDC system supports data entry and study workflows such as source data verification and monitoring, site payments, real-time reporting, biokit ordering, and biosample shipment tracking. The role provides functional leadership to systems administration and EDC support staff and may take on direct people-management responsibilities as the team grows. CHDI Foundation, Inc. is a privately funded nonprofit biomedical research organization dedicated to collaboratively developing therapeutics for people affected by Huntington’s disease. Its scientists work with a global network of more than 700 researchers and support activities spanning exploratory biology, target identification and validation, drug discovery and development, and clinical studies and trials. Staff work for CHDI Management, Inc., which provides administrative and management services to the Foundation. The position is based in Princeton, New Jersey, and requires two days per week in the office. Candidates must be local to Princeton. Vaccination against COVID-19 is a prerequisite for employment at CHDI Management. The salary range is $80,000–$150,000, with exact compensation varying based on experience.

Requirements

Bachelor’s degree in life sciences, health sciences, information systems, computer science, or a related discipline.
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.
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.
Must be local to Princeton, New Jersey, and able to work in the office two days per week.
Vaccination against COVID-19 is a prerequisite for employment at CHDI Management.

Nice To Haves

Prior team leadership, mentoring, or people-management experience.

Responsibilities

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 in 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.
Test EDC databases to confirm they function as designed, meet documented requirements, and are 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.
Manage concurrent projects and sub-projects, including initiatives intersecting 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.
Recommend project sequencing, resourcing, trade-offs, risks, and decision options.
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.
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 to 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.
Clearly communicate status, risks, dependencies, and decisions to technical and nontechnical stakeholders.