What are the responsibilities and job description for the Clinical Data Manager position at Meditrial?
We're looking for a skilled and detail-oriented Clinical Data Manager to join our medical device trials team. You'll own the full data management lifecycle across Phase I–IV studies, ensuring data integrity, regulatory compliance, and on-time delivery. This is a high-impact role for someone who thrives in a fast-paced, multi-project environment and takes pride in clean, audit-ready data. The position is office based in our US Minneapolis Office.
Responsibilities
Responsibilities
- Lead end-to-end clinical data management activities for medical device studies across multiple therapeutic areas and all trial phases (I–IV)
- Design, build, and validate eCRFs and clinical databases using industry-standard EDC platforms (Medidata Rave, Oracle InForm, Veeva Vault, or similar)
- Develop and maintain key data management documents including DMPs, DVPs, edit check specifications, and data transfer agreements
- Perform ongoing data review, query management, and SAE reconciliation to ensure timely, high-quality data
- Collaborate with biostatistics, clinical operations, regulatory affairs, and medical monitors throughout the trial lifecycle
- Ensure all data management activities comply with FDA 21 CFR Part 11, ISO 14155, ICH E6(R2) GCP, MDR and applicable regulatory frameworks
- Support internal and sponsor audits; maintain inspection-ready TMF documentation
- Contribute to process improvement initiatives and SOP development
- 5 years of clinical data management experience, with at least 2 years in medical devices
- Hands-on proficiency with one or more EDC/CDMS platforms (Medidata Rave, Oracle InForm, Veeva Vault, or equivalent)
- Solid working knowledge of FDA 21 CFR Part 11, ISO 14155, and ICH GCP E6(R2)
- Experience managing data across multiple concurrent studies and therapeutic areas
- Strong understanding of CDISC standards (CDASH, SDTM) is a plus
- Exceptional attention to detail and a systematic approach to problem-solving
- Excellent written and verbal communication skills; comfortable interfacing with sponsors and cross-functional teams
- Bachelor's degree in a life sciences, health informatics, or related field (Master's a plus)