More jobs:
Clinical Data Manager
Job in
Woodbury, Washington County, Minnesota, USA
Listed on 2026-07-06
Listing for:
Meditrial
Full Time
position Listed on 2026-07-06
Job specializations:
-
IT/Tech
Data Security, Data Analyst, Data Warehousing
Job Description & How to Apply Below
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 Minneapolis.
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)
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×