Clinical Data Management Study Conduct & Closeout Discrepancy / Query Management SAE & External Data Reconciliation (IWRS, Central Lab)
Responsibilities/Expectation from the role.
Own and manage assigned study conduct activities for clinical trials from TCS. Validate clinical trial data for accuracy, consistency, and integrity as per protocol and guidelines. Raise and manage system/manual queries to resolve data discrepancies. Perform external data reconciliations, including SAE, IWRS, and Central Lab data. Act as SPOC for all study‑related communications from TCS. Proactively identify study risks and drive mitigation plans. Collaborate with stakeholders to ensure timely, high‑quality deliverables. Drive process improvements and share learnings within the team.
Required Qualifications
Clinical Data Management expertise
2+ years of experience in clinical trials
Discrepancy Management expertise
Preferred Qualifications
Experience with SAE reconciliation
Knowledge of IWRS systems
Familiarity with Central Lab processes
Skills Required
Clinical Data ManagementQuery ManagementData ReconciliationStakeholder CollaborationProcess Improvement