You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings – Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.
The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also manages clinical data management projects.
You will be expected to use strategies, methods, and tools used throughout the lifecycle of the clinical trial regulated content. This includes data review and accuracy checks of trial master file table of contents, headquarters, initial full protocol package and amended FPP checklists, end of trial checklists, essential document reconciliation, and clinical study report appendices.
What are we looking for?
- Adaptable and flexible
- Ability to perform under pressure
- Problem-solving skills
- Detail orientation
- Ability to establish strong client relationships
Roles and Responsibilities:
- Solve routine problems, largely through precedent and referral to general guidelines
- Interact within your own team and direct supervisor
- Follow detailed to moderate level of instruction on daily work tasks and new assignments
- Make decisions impacting your own work
- Work as an individual contributor as part of a team, with a predetermined, focused scope of work
- Work in rotational shifts if required