Senior EDC Lead
Core
Lead the design and delivery of clinical trial systems (EDC, IRT, ePRO) ensuring compliance with standards and regulations.
Role type
Senior EDC Lead (Clinical Data Strategy)
Builds
Clinical trial systems and integrations for study execution
Domain
Clinical Trials / Life Sciences
Deliverable
production ML models | product features | infrastructure
Required skills
EDC technical study build, Medidata RAVE, CDASH, SDTM, clinical trial process knowledge, system design, project management, regulatory compliance (GCP, ICH), team mentoring
Preferred skills
Veeva EDC technical study build experience
Technologies
Medidata RAVE, Veeva EDC
Responsibilities
Develop common data standards and ensure system designs comply; Establish and maintain methodology for designing clinical trial systems; Ensure TA- and program-level consistency; Account for on-time design and delivery of new clinical systems and integrations; Interact with cross-functional teams to achieve program objectives; Ensure adherence to federal regulations, GCPs, and ICH Guidelines; Coach and mentor team members; Lead innovation and process improvement initiatives
Seniority
Senior, hands-on IC with mentorship responsibilities