Associate Director, Electronic Data Capture Engineer Developer
Takeda
2 months ago
Remote
United States
$154,400 - $242,550 USD yearly
IT
Associate Director, Electronic Data Capture Developer (remote; Massachusetts - Virtual)
Responsibilities
- Lead and oversee EDC Developers; ensure compliant, on-time delivery of EDC build/maintenance systems and documentation across a portfolio.
- Own staffing, capacity, coverage planning; coach/mentor direct reports; performance management.
- Ensure compliance with Takeda SOPs; partner with Data Management/Standards and others to improve processes.
- Lead EDC design/build strategy, validation approach, risk mitigation, and end-to-end database build timelines.
- Oversee functional testing, eCRF specification/design/programming/validation/trial setup; manage edit checks and trial data quality controls.
- Govern environment/release promotion; manage post-production change control and audit readiness (validation packages, test evidence, access controls, issue logs, TMF readiness).
- Lead audit/inspection coordination and cross-functional alignment; troubleshoot and resolve complex production issues; manage archiving after database lock.
Qualifications & Skills
- Bachelor’s degree or related experience; knowledge of drug development.
- 15+ years in Data Management/Programming/Clinical IT or related clinical research fields.
- 12+ years programming clinical trials in EDC (e.g., Veeva CDMS, RAVE, Inform, Zelta, Medrio).
- Hands-on Veeva Clinical Data design.
- Preferred: understanding of CQL and/or C#.
- Experience with EDC integrations (lab, safety, IRT, coding, etc.) and clinical development technologies (CTMS, IRT, eCOA, SAS, SharePoint).
- Experience mentoring EDC leads; cross-functional risk management/escalation; internal/vendor audits and health authority inspections.
Benefits (if eligible)
- Medical/dental/vision; 401(k) + match; disability and life insurance; tuition reimbursement; paid volunteer time off; holidays; well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
Application instructions
- Apply via the “Apply” button; employment application information is processed per Takeda’s Privacy Notice and Terms of Use.
Responsibilities
- Lead and oversee EDC Developers; ensure compliant, on-time delivery of EDC build/maintenance systems and documentation across a portfolio.
- Own staffing, capacity, coverage planning; coach/mentor direct reports; performance management.
- Ensure compliance with Takeda SOPs; partner with Data Management/Standards and others to improve processes.
- Lead EDC design/build strategy, validation approach, risk mitigation, and end-to-end database build timelines.
- Oversee functional testing, eCRF specification/design/programming/validation/trial setup; manage edit checks and trial data quality controls.
- Govern environment/release promotion; manage post-production change control and audit readiness (validation packages, test evidence, access controls, issue logs, TMF readiness).
- Lead audit/inspection coordination and cross-functional alignment; troubleshoot and resolve complex production issues; manage archiving after database lock.
Qualifications & Skills
- Bachelor’s degree or related experience; knowledge of drug development.
- 15+ years in Data Management/Programming/Clinical IT or related clinical research fields.
- 12+ years programming clinical trials in EDC (e.g., Veeva CDMS, RAVE, Inform, Zelta, Medrio).
- Hands-on Veeva Clinical Data design.
- Preferred: understanding of CQL and/or C#.
- Experience with EDC integrations (lab, safety, IRT, coding, etc.) and clinical development technologies (CTMS, IRT, eCOA, SAS, SharePoint).
- Experience mentoring EDC leads; cross-functional risk management/escalation; internal/vendor audits and health authority inspections.
Benefits (if eligible)
- Medical/dental/vision; 401(k) + match; disability and life insurance; tuition reimbursement; paid volunteer time off; holidays; well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
Application instructions
- Apply via the “Apply” button; employment application information is processed per Takeda’s Privacy Notice and Terms of Use.