Electronic Data Capture Development & Operations Manager
$80k - $150k
Senior
Bachelor's
Princeton, NJ, USA
HybridBased in Princeton, NJ; required in-office attendance 2 days per week.
Biology & BiotechClinical Research Operations
About the job
Requirements
- A 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, contract research organization, or clinical research environment.
- At least 3–5 years of hands-on electronic data capture 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 electronic data capture platforms.
- Strong knowledge of electronic data capture database development lifecycles, electronic case report form design, edit checks, study workflows, testing, release management, and change control.
- Working knowledge of Good Clinical Practice, 21 CFR Part 11, Clinical Data Acquisition Standards Harmonization, Clinical Data Interchange Standards Consortium, computer system validation, and clinical data standards.
- Ability to translate protocols and business needs into practical technical solutions while balancing quality, timelines, cost, and operational risk.
- Vaccination against COVID-19 is a prerequisite for employment.
Responsibilities
- Lead end-to-end electronic data capture study builds, including requirements gathering, design, configuration, testing, validation, deployment, maintenance, amendments, and database lock support.
- Translate study protocols into technical specifications for electronic case report forms, visit schedules, edit checks, dynamics, derivations, workflows, user roles, and permissions.
- Configure and maintain study databases in sponsor-supported electronic data capture 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, electronic clinical outcome assessment and electronic patient-reported outcome systems, imaging systems, wearables, and other digital health technologies; review transfer specifications and reconciliation requirements.
- Test the electronic data capture 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 electronic data capture systems and study databases comply with Good Clinical Practice, 21 CFR Part 11, internal standard operating procedures, quality standards, and other applicable regulatory requirements.
- Manage multiple concurrent projects and sub-projects, including initiatives that intersect with electronic data capture system and vendor deliverables.
- Develop and maintain project plans, timelines, dependencies, risks, mitigation strategies, and status reporting.
- Develop and maintain standard operating procedures, 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.
- Serve as the primary operational contact for electronic data capture 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 electronic data capture-related initiatives.
- Provide functional leadership to systems administration and electronic data capture support staff, including work allocation, prioritization, mentoring, and technical guidance.
- Identify capability gaps and support training and development plans that build sustainable internal electronic data capture and clinical systems expertise.
- Partner with Clinical Operations, Data Management, Biostatistics, Information Technology, Medical Monitoring, Study Management, and external vendors to deliver study objectives.
- Communicate status, risks, dependencies, and decisions clearly to technical and nontechnical stakeholders.
Desired Qualifications
- Prior team leadership, mentoring, or people-management experience.
About the company
CHDI Management provides administrative, management, and contracting services to CHDI Foundation and other non-profit organizations dedicated to Huntington’s disease (HD) research. It supports rapid discovery and development of HD therapies by handling operations so researchers can focus on science. The company’s work is service-based, not a product; its staff and offices enable global collaboration with academic and industry scientists. CHDI Management differentiates itself by its exclusive focus on Huntington’s disease and its role as the coordinating, nonprofit-backed management arm for HD research initiatives. Its goal is to increase understanding of HD and hasten the development of therapies to delay or slow the disease.
Company Size
51-200
Company Stage
N/A
Total Funding
N/A
Headquarters
New York City, New York
Founded
2003
Get referred to CHDI Management
See people who can refer or advise you
Simplify's Take
What believers are saying
- On May 26, 2026, Prilenia gave CHDI placebo-arm data from PRIDE and PROOF.
- At CHDI's February 2026 conference, AMT-130 showed 75% disease-slowing at three years.
- CHDI and Regeneron sequenced 18,874 Enroll-HD samples, expanding biomarker and genetics power.
What critics are saying
- CHDI depends on Huntington's disease breakthroughs; one field-wide setback freezes its mission.
- If donor funding tightens in 2027, CHDI's outsourced model loses operating leverage.
- Negative AMT-130 or SKY-0515 data would damage CHDI's core thesis and partner pipeline.
What makes CHDI Management unique
- CHDI is a privately funded nonprofit dedicated solely to Huntington's disease.
- Its virtual model outsources science while coordinating discovery, development, and data sharing.
- Enroll-HD plus whole-genome sequencing give CHDI unusually deep Huntington's datasets.
Help us improve and share your feedback! Did you find this helpful?
Benefits
- Hybrid Work Options