Clinical Data Manager
Skills
Computer ScienceBiotechnologyClinical Data ManagementData IntegrityDatabasesMedical DevicesMedidata
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- Bachelor's Degree in Data Science Computer Science Information Technology or related field OR Master's degree or advanced degree in pharmaceutical medical or relevant biomedical science fields with data management experience
- 5-8 years of clinical data management experience in biotechnology pharmaceutical medical device diagnostics or companion diagnostic development
- Hands-on experience with CDISC standards including SDTM ADaM CDASH and Define.xml
- Experience designing and managing studies using EDC platforms such as Medidata Rave Veeva CDMS/EDC Oracle InForm REDCap or equivalent systems
- Direct experience supporting oncology clinical trials biomarker-driven studies companion diagnostics precision medicine programs or regulated IVD development preferred
- Ability to interpret regulatory standards guidance and laws
- Exceptional ability to manage multiple projects in a fast-paced environment with changing priorities
- Ability to make independent decisions and take initiative to lead projects and assignments
- Experience working with external partners and/or regulatory bodies
- Knowledge of cancer diagnostics Oncology and/or Pathology preferred
Nice to have
- detail-oriented
- cross-functional
- self-directed
- proactive
- organized
Day to day
- Lead end-to-end clinical data management for companion diagnostic studies with rigorous planning and execution
- Design and validate EDC/CRF systems while managing external data integration reconciliation and database lock activities
- Collaborate across clinical biostatistics programming quality and regulatory teams to deliver accurate compliant submission-ready datasets and documentation