Senior Clinical Data Manager

100% Remote
Job Description Senior Clinical Data Manager
Role Overview
We are seeking an experienced Clinical Data Manager (CDM) to support multiple outsourced clinical studies. The ideal candidate will have strong hands-on expertise in EDC systems, data review activities, vendor data reconciliation, and CRO oversight.

Responsibilities
Manage 4 concurrent clinical studies outsourced to CROs, ensuring data integrity and compliance.
Oversee day-to-day data review activities in the EDC, including edit checks, query management, and discrepancy resolution.
Coordinate with external vendors (labs, ECG, imaging, ePRO, etc.) to ensure timely and accurate data transfers.
Perform vendor data reconciliation with EDC, including SAE reconciliation with safety databases.
Review and validate study documents: edit check specifications, CRFs/eCRFs, data transfer specs.
Communicate regularly with CROs, vendors, and internal study teams via email and status calls.
Track deliverables, timelines, and quality metrics; escalate issues as needed.
Support database freeze and lock activities, ensuring compliance with CDISC, ICH-Google Cloud Platform, and 21 CFR Part 11.
Maintain study trackers, documentation, and audit-ready records.

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Requirements
Bachelor s degree in Life Sciences, Pharmacy, Computer Science, or related field (Master s preferred).
6 10 years of CDM experience, preferably in a CRO or pharma setting.
Hands-on experience with EDC systems (Medidata Rave, Oracle Clinical, Inform, or Veeva).
Strong understanding of vendor data management and reconciliation processes.
Familiarity with CDISC standards (CDASH, SDTM).
Knowledge of ICH-Google Cloud Platform and 21 CFR Part 11 regulations.
Excellent communication and stakeholder management skills.
Ability to manage workload of 30 35 hours per week across multiple studies with tight timelines.