Senior Clinical Data Manager
C
CoMindMedical Devices
Remote, US, Eastern or Central Time zoneFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 5+ years
- Required Skills
- GCP
Requirements
- Bachelor’s degree.
- 5+ years of clinical data management experience.
- Hands-on experience with eCRF design, database build, and edit check configuration.
- Experience executing UAT scripts for electronic data capture systems.
- Experience administering EDC/CDMS and eTMF user access.
- Strong working knowledge of GCP, 21 CFR Part 11, 21 CFR Part 812, ICH E6(R3), and ISO 14155.
- Experience managing data management vendors and CROs.
- Excellent oral and written communication skills.
- Sponsor-side clinical data management experience in medical device, biotech, or pharma.
Responsibilities
- Design, build, and configure clinical study databases (EDC, CTMS, eTMF).
- Execute and document user acceptance testing (UAT) of clinical databases.
- Manage user account provisioning and access controls per 21 CFR Part 11.
- Develop data management plans, CRF guidelines, and protocol deviation specifications.
- Perform ongoing data review, query management, and discrepancy resolution.
- Define data transfer specifications and perform external data reconciliation.
- Execute database lock activities for regulatory submissions.
- Ensure compliance with GCP, CDISC, 21 CFR Part 11, and ISO 14155.
- Manage data management vendor and CRO relationships.
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