Our Sr. Clinical Data Manager will be responsible for managing all data management activities, from start-up to database lock, across multiple global medical device clinical trials while ensuring quality and compliance standards are aligned with applicable regulations, Good Clinical Data Management Practices, and standard operating procedures.
With limited direction, responsible for planning and executing clinical data management activities in clinical studies and data management teams.
Provide data management input during the protocol development on assigned studies.
Facilitate CRF/eCRF design ensuring all data required per specifications in the protocol are captured appropriately on the CRFs.
Lead the development of the eCRF design specifications, data transfer agreements, UAT execution, and query check specifications.
Develop, document, and maintain data management study related documentation including and provide study-specific data management training for team members as necessary.
Develop edit check content, manage data query generation and resolution.
Oversee data review activities within the clinical database.
Lead AE/SAE and Device Discrepancy reconciliation of clinical data
Coordinate database lock procedures, including all QC efforts, in-line with database lock requirements.
Ensures that all activities under responsibility are properly documented (traceability of changes, data specifications) according to the internal guidance documents
Keeps abreast and look for opportunities for applying innovative data management methods and enhancements.
Understands and follows all Statistics & Data Management Quality Documents.
Reviews/contributes to project management plan of clinical activities and ensure that deadlines are met.
Develops, applies and maintains standard database specifications, edit checks, and data review tools.
Collaborates effectively with Statistics & Data Management internal and external partners in all activities where handling and reviewing of clinical data is needed.
Communicates technical clinical data management concepts in a clear, concise, focused, and articulate manner.
Works according to ICH-GCP, other international guidelines (e.g., ISO), working group recommendations (e.g., CDISC or Good Clinical Data Management Practices) as well as internal quality system.
Bachelor’s degree preferably in Computer Science, Life Science, or other related field
5- 8 years of experience in a clinical data management team during study startup, conduct, and database lock phases in pharmaceutical, medical device, or CRO
Successfully managed clinical data management activities with full responsibility and independence
Experience reporting study status and participating in study team discussions, with study stakeholders
Experience with providing study metrics and/or data entry metrics
Technical experience in leading the design, build, and validation activities of CDMS and EDC platforms
Clinical understanding of medical terminology, medical terms coding, and adverse event reporting