Lead, Sr Clinical Data Programming
- Experience Level
- Experienced (non-manager)
Clinical Data Programming Lead
In this central role, you will be responsible for supporting CDMS Programming activities as related to building study databases, system reports and configuring other system features. As a Clinical Data Programming Lead you can also function as a Team Lead for CDMS Programmers, ensuring team delivers to expected quality and timelines and providing technical oversight and training/mentoring.
· Participates in study specific database set-up using Medidata Rave.
· Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS).
· Creates/Programs edit checks, special actions and derivations as per a DVS.
· Works closely with centralized CDMS Testing Group to ensure all programming issues are resolved in a timely manner and study timelines are met
· Trouble-shoots and solves study building issues and edit check programming issues.
· Set up Coder, IRT, T-SDV, and Rave Safety Gateway integrations.
· Run Screen Review Meetings with sponsors and act as point of contact for all Rave questions.
Serves as Team lead to CDMS Programmers, providing training, best practices, support and quality checks on study build and programming; ensure effective resource allocation and workload balancing across assigned team members
Extend technical expertise and mentor team members on an ongoing basis; ensure team achieves productivity and quality targets, perform benchmarking reviews and perform oversight of deliverables using different tools/ techniques and maintain and report relevant metrics. Contributes to training materials on a process, system or technology level. Works with CTD and CDMS. Management on delivery of training courses, instructor-led and on-the-job.
To succeed you will need:
The successful individual will have a proven experience in study build set up; possess a strong understanding of the principles of system development lifecycle and governance and be able to perform assigned tasks with minimum supervision.
The requirements listed below are representative of the knowledge, skill, and/or ability required:
· Prior relevant experience in building study databases
· Ability to successfully manage multiple tasks and timelines
· Experience in Medidata Rave
· Team player with strong verbal and written communication skills
· Demonstrated ability to learn new technologies, applications and techniques
· Understanding of database concepts.