Principal Electronic Data Capture Developer
Takeda
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Salary
💰 $137,000 - $215,270 per year
Job Level
About the role
- Work on EDC activities and oversee delivery of systems and documentation to support Takeda Clinical trials.
- Work with Takeda study teams to develop eCRF specifications, build and/or oversee implementation of Case Report Forms (eCRFs) for clinical trials.
- Manage and oversee EDC system configuration, dictionaries, and integrations.
- Accountable for the successful delivery, quality, and compliance of all EDC studies and study leads under their oversight.
- Provides mentorship and guidance to study leads, proactively manages risks, and leads escalation and resolution of complex issues to ensure study milestones are met.
- Operates in compliance with Takeda SOPs and processes while working with Data Management and Standards Teams to enhance existing processes.
- Understand Clinical Data Acquisition Standards Harmonization (CDASH) and Study Data Tabulation Model (SDTM) standards and concepts while considering EDC platform best practices.
Requirements
- Bachelor's degree or related experience.
- Knowledge of drug development process.
- Minimum of 12+ years’ experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields.
- Minimum 10+ years’ experience in programming clinical trials in EDC in systems such as Veeva CDMS, RAVE, Inform, Zelta, Medrio, etc..
- Hands-on experience with designing in Veeva Clinical Data (formerly Veeva CDMS).
- Understanding of CQL and/or C# is preferred but not required.
- Experience overseeing integrations of the EDC database with other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,).
- Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, IRT, eCOA, SAS, SharePoint).
- Demonstrated experience providing technical and functional oversight of multiple EDC studies and study leads simultaneously.
- Proven ability to mentor, coach, and develop EDC study leads.
- Experience leading cross-functional decision-making, risk management, and escalation for complex clinical trials.
- Experience supporting internal audits, vendor audits, and health authority inspections related to EDC systems and data.
Benefits
- U.S. based employees may be eligible for short-term and/or long-term incentives.
- U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
- U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
EDC activitieseCRF specificationsCase Report FormsEDC system configurationCQLC#programming clinical trialsdata managementclinical ITclinical research
Soft Skills
mentorshipguidancerisk managementproblem resolutioncross-functional decision-makingcoachingdevelopment of study leadsproactive managementcommunicationoversight