Principal, Electronic Data Capture Developer
Takeda
4 months ago
Remote
United States
$137,000 - $215,270 USD yearly
IT
Principal, Electronic Data Capture (EDC) Developer
Responsibilities:
- Work on EDC activities and oversee delivery of systems and documentation to support Takeda clinical trials.
- Partner with study teams to develop eCRF specifications and build/oversee implementation of eCRFs.
- Manage EDC system configuration, dictionaries, and integrations.
- Ensure successful delivery, quality, and compliance of EDC studies; mentor study leads; manage risks; escalate and resolve complex issues.
- Operate in compliance with Takeda SOPs/processes; collaborate with Data Management and Standards to enhance processes.
- Apply CDASH and SDTM standards/concepts using EDC platform best practices.
- Create eCRF specifications; design/program/validate EDC database setup.
- Review and program edit checks; set up trial URL instances (UAT, production, testing, etc.).
- Lead database build end-to-end timeline; drive EDC design/build strategy and risk mitigation.
- Configure and maintain user accounts; set up blinded/unblinded study configurations.
- Perform and document functional testing; validate integrations (coding, IRT, eCOA, safety, local labs, etc.).
- Troubleshoot database design/maintenance issues; implement post-production changes while ensuring data integrity.
- Archive/retire study URL after database lock; confirm archival/inspection readiness of TMF documents.
- Participate in submission readiness; track deliverables and escalate risks.
- Represent EDC in governance forums; collaborate across clinical operations, clinical supplies, IT, and quality.
Qualifications / Skills:
- Bachelor’s degree or related experience.
- Knowledge of drug development process.
- 12+ years in Data Management, Programming, Clinical IT, or other Clinical Research fields.
- 10+ years programming clinical trials in EDC systems (e.g., Veeva CDMS, RAVE, Inform, Zelta, Medrio).
- Hands-on Veeva Clinical Data design (formerly Veeva CDMS).
- Understanding of CQL and/or C# preferred but not required.
- Experience overseeing EDC database integrations (lab, safety, IRT, coding, etc.).
- Understanding of clinical development technologies (e.g., CTMS, IRT, eCOA, SAS, SharePoint).
- Demonstrated technical/functional oversight of multiple EDC studies/study leads.
- Proven ability to mentor/coach EDC study leads.
- Experience leading cross-functional decision-making, risk management, and escalation for complex trials.
- Experience supporting internal audits, vendor audits, and health authority inspections related to EDC systems/data.
Application instructions:
- Apply online; by clicking “Apply,” acknowledge your application process will commence and your information will be processed per Takeda’s Privacy Notice and Terms of Use.
Responsibilities:
- Work on EDC activities and oversee delivery of systems and documentation to support Takeda clinical trials.
- Partner with study teams to develop eCRF specifications and build/oversee implementation of eCRFs.
- Manage EDC system configuration, dictionaries, and integrations.
- Ensure successful delivery, quality, and compliance of EDC studies; mentor study leads; manage risks; escalate and resolve complex issues.
- Operate in compliance with Takeda SOPs/processes; collaborate with Data Management and Standards to enhance processes.
- Apply CDASH and SDTM standards/concepts using EDC platform best practices.
- Create eCRF specifications; design/program/validate EDC database setup.
- Review and program edit checks; set up trial URL instances (UAT, production, testing, etc.).
- Lead database build end-to-end timeline; drive EDC design/build strategy and risk mitigation.
- Configure and maintain user accounts; set up blinded/unblinded study configurations.
- Perform and document functional testing; validate integrations (coding, IRT, eCOA, safety, local labs, etc.).
- Troubleshoot database design/maintenance issues; implement post-production changes while ensuring data integrity.
- Archive/retire study URL after database lock; confirm archival/inspection readiness of TMF documents.
- Participate in submission readiness; track deliverables and escalate risks.
- Represent EDC in governance forums; collaborate across clinical operations, clinical supplies, IT, and quality.
Qualifications / Skills:
- Bachelor’s degree or related experience.
- Knowledge of drug development process.
- 12+ years in Data Management, Programming, Clinical IT, or other Clinical Research fields.
- 10+ years programming clinical trials in EDC systems (e.g., Veeva CDMS, RAVE, Inform, Zelta, Medrio).
- Hands-on Veeva Clinical Data design (formerly Veeva CDMS).
- Understanding of CQL and/or C# preferred but not required.
- Experience overseeing EDC database integrations (lab, safety, IRT, coding, etc.).
- Understanding of clinical development technologies (e.g., CTMS, IRT, eCOA, SAS, SharePoint).
- Demonstrated technical/functional oversight of multiple EDC studies/study leads.
- Proven ability to mentor/coach EDC study leads.
- Experience leading cross-functional decision-making, risk management, and escalation for complex trials.
- Experience supporting internal audits, vendor audits, and health authority inspections related to EDC systems/data.
Application instructions:
- Apply online; by clicking “Apply,” acknowledge your application process will commence and your information will be processed per Takeda’s Privacy Notice and Terms of Use.