Clinical Data Manager

Overview

Remote
Depends on Experience
Accepts corp to corp applications
Contract - Independent
Contract - W2

Skills

Clinical Data Management
DTA
Data Transfer Agreement
vendor relations
Data Acquisition
3rd Party
FDA
ICH
Veeva TMF
CDMS
eCOA

Job Details

Key Responsibilities

 

  • Design, build, and maintain clinical trial databases as per study protocol and CRF requirements

  • Develop and review Data Management Plans (DMPs), edit check specifications, and validation rules

  • Oversee data cleaning, discrepancy management, and query resolution

  • Perform interim and final database lock activities

  • Ensure data quality, completeness, and consistency throughout the study lifecycle

< data-start="1144" data-end="1174">DTA Vendor Management</>

  • Act as the primary point of contact for DTA (Data Transfer Agreement) vendors

  • Manage data transfer specifications, schedules, and reconciliation activities

  • Review and approve vendor data deliverables for accuracy and compliance

  • Track vendor timelines, issues, and change requests

  • Coordinate UAT and production data transfers with internal and external stakeholders

< data-start="1575" data-end="1621">Systems & Tools (Including Veeva CRM)</>

  • Support clinical data integration with Veeva CRM for field medical and commercial data alignment (where applicable)

  • Collaborate with cross-functional teams to ensure accurate data flow between EDC, vendor systems, and Veeva platforms

  • Maintain system documentation and support system-related audits and inspections

< data-start="1953" data-end="1992">Cross-Functional Collaboration</>

  • Work closely with Clinical Operations, Biostatistics, Medical, Pharmacovigilance, and IT teams

  • Participate in study team meetings and provide data status updates

  • Support regulatory submissions, audits, and inspections

Required Skills & Experience

  • Strong knowledge of Clinical Data Management processes

  • Hands-on experience with EDC systems (Medidata Rave, Oracle Clinical, Inform, Veeva Vault CDMS)

  • Proven experience managing DTA vendors and external data transfers

  • Working knowledge of Veeva CRM or similar Veeva ecosystem tools

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