Role Overview:
- Alignment: Life Sciences R&D vertical
- Services Span: Entire life sciences enterprise, from research laboratories and clinical trials support to regulatory services, pharmacovigilance, and patient services solutions.
- Sub-offerings: Clinical, Pharmacovigilance & Regulatory
- Objective: Help biopharma companies improve outcomes by converging around the patient and connecting scientific expertise with insights into the patient experience.
Clinical Data Management Team:
- Focus on the collection, integration, and availability of data at appropriate quality and cost.
- Responsible for performing data management activities including discrepancy review, query generation, and resolution.
- Creation of CRF Completion Guidelines (CCG) and SAE reconciliation guidelines.
- Identification and raising of protocol deviations in the database.
- Edit check validation through test cases, test scripts, and database validation (UAT).
- Managing clinical data management projects.
- Providing medical expertise for trial oversight and safety concerns.
Roles and Responsibilities:
- Solve routine problems largely through precedent and general guidelines.
- Expected interactions within your own team and direct supervisor.
- Provided detailed to moderate instruction on daily tasks and new assignments.
- Impact decisions primarily on your own work.
- Serve as an individual contributor with a focused scope of work.
- Role may require rotational shifts.
