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
About CHDI Foundation, Inc.
CHDI Foundation, Inc. is a privately funded nonprofit biomedical research organization exclusively dedicated to collaboratively developing therapeutics that will substantially improve the lives of those affected by Huntington’s disease (HD). Our scientists work closely with a network of more than 700 researchers in academic and industrial laboratories around the world in the pursuit of these novel therapies, providing strategic scientific direction to ensure that our common goals remain in focus. This helps bridge the translational gap that often exists between academic and industrial research pursuits and that adds costly delays to therapy development. In its role as a collaborative enabler, CHDI seeks to bring the right partners together to identify and address critical scientific issues and move drug candidates to clinical evaluation as rapidly as possible. Our activities extend from exploratory biology to the identification and validation of therapeutic targets, and from drug discovery and development to clinical studies and trials. More information about CHDI can be found at www.chdifoundation.org .
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 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…