Location: Remote – Thousand Oaks, CA
Employment Type: Contingent Worker (Contract, W2)
Compensation: Open Market Rate
Summary of the Role
Join a big biopharma leader as an eCOA Technical Specialist. You’ll manage study-level eCOA delivery across vendors (e.g., Clario, Signant Health, Medidata, Clinical Ink), drive requirements and governance, troubleshoot issues, and guide teams on translations/licensing and best practices. Success requires strong project management, vendor coordination, and clear documentation (e.g., in Merit).
Key Responsibilities
Own quality delivery within the eCOA service area and support continuous process/quality improvements
Lead/oversee system requirements meetings with eCOA vendors and internal stakeholders
Author/review study-specific technical specifications and related documents
Track timelines and associated activities; manage escalations with vendors
Partner with Data Management to define data transfer requirements
Coordinate and oversee UAT planning/execution with external resources
Identify, log, and drive resolution of study-related technical issues
Required Experience & Skills
3+ years eCOA project management with recognized vendors (Clario, Signant, Medidata, Clinical Ink, etc.)
Experience with eCOA governance/issue management and specification review/authoring; exposure to translation/licensing processes
Strong PM skills: timeline ownership, vendor relationship management, risk/issue tracking, escalation management
Effective communicator and collaborator; able to guide global CTMs and document in systems like Merit
Professional, adaptable, team-oriented; steady work history (2–3 years per role preferred)
Preferred Qualifications
Bachelor’s in life science, CS/engineering, business, or related (hands-on eCOA experience prioritized over formal education)
4+ years in clinical development; implementation experience with CTMS, EDC, IVRS/IRT, ePRO, or related tech
Working knowledge of GCP and FDA expectations; PMP a plus
Excellent documentation, time management, and organization; sound judgment and problem solving
Prior vendor management experience; thrives with minimal supervision
Top 3 Must Have Skills
eCOA project management (≥3 years)
eCOA governance / issue management
eCOA specification review/authoring + translation support
Basic Qualifications
Doctorate degree, OR
Master’s degree and 3 years of clinical experience, OR
Bachelor’s degree and 5 years of clinical experience, OR
Associate degree and 10 years of clinical experience, OR
High school diploma/GED and 12 years of clinical experience
"This posting is for Contingent Worker, not an FTE"