The Manager, EDC Database Programming is a member of the Biostatistics and Data Management team and serves as a subject‑matter expert for the oversight, guidance, and design of study build activities for all clinical studies Electronic Data Capture systems and related technologies, Clinical Data Programming and Reporting. The scope of work includes ownership and oversight of the study design, build, edit check and custom function programming activities, including the review of CRF specifications and data validation specifications. In addition, the position involves assisting with functional and user acceptance testing, and managing quality deliverables in partnership with RAVE Administrator, Study Data Managers, and functional service providers. The individual will also engage in the governance, management, and advancement of DS Global Library Standards and will work closely with other members of the Biostatistics and Data Management, external CRO partners, service providers, and other stakeholders.
Responsibilities- Provide guidance and manage accountability for study build activities ensuring high quality, consistency, and adherence to eCRF specifications established for each study.
- Manage all study build deliverables for timely delivery and implementation of high‑quality study builds for all studies in conformance with DS standards and eCRF specifications.
- Manage and maintain administrative and operational deliverables, timelines, and documentation for study build activities, edit check programming, and custom function development.
- Collaborate with study data managers, external CROs, and service providers to ensure study build configuration is reviewed, tested, and completed with high quality and on schedule.
- Guide the operational execution of steps and procedures to ensure consistency and accuracy of study builds.
- Proactively identify and resolve issues that may influence or impact study build quality and other deliverables.
- Review and provide input to quality database designs for fit and feasibility within the EDC application and ensure consistency with established standards.
- Ensure system interfaces are designed and configured for optimal use and not in conflict with study build and relevant specifications.
- Lead or provide oversight to functional and user acceptance testing activities including edit check and custom function test scripts, programming, and validation tasks.
- Lead or provide oversight on the impact analysis and risk assessment of study build change requests, maintain documentation, and facilitate implementation of changes per the change control procedures.
- Track, debug, and resolve issues pertaining to study build and programming tasks for all studies.
- Identify opportunities for continuous process improvements, improve work procedures, QC procedures, checklists, and study build performance metrics.
- Contribute to development of content and training for all aspects of study build activities in partnership with study data managers and functional service providers.
Qualifications
Education Qualifications
Bachelor's Degree in Life Sciences or related field required; Master’s Degree preferred.
Experience Qualifications- Minimum of 5 years of EDC study build and database programming experience and data validation programming in the device/pharmaceutical/CRO industry.
- Expertise in Clinical Programming, methods, and techniques.
- Knowledge of industry standard clinical technologies including CTMS, EDC, Clinical Data Repository (CDR); CDASH and CDISC data standards; data acquisition and integration tools and technologies.
- Worked collaboratively with people at different levels of experience, across disciplines and cultures.
- Self‑directed and able to work independently.
- Strong communication, negotiation, and conflict resolution skills.
- Ability to manage multiple priorities.
- Strong background in Clinical Programming, Project Management, and data acquisition methods.
Daiichi Sankyo, Inc. is an equal‑opportunity/affirmative‑action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary RangeUSD$127,280.00 - USD$190,920.00
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