Name of the POST : Senior Clinical Data Manager
Location : Bangalore
The Position :
- Ensuring the integrity of clinical trial databases.
- Perform Data Validation ensuring completeness and clean data.
- Ensure availability of data to relevant stakeholders.
- Write, send, update, and resolve data clarifications.
- Create test cases and test validation procedures.
- Perform UAT of the database.
- Generate reports and communicate with stake holders in a timely manner
- Understand and comply with all applicable standard operating procedures and working instructions.
- Develop and maintain good communications and working relationships with Data Management team.
- Assist in timely scanning, book marking and indexing of documents in novoDOCS
- Ensure good documentation practices are followed.
- The Clinical Data Manager in alignment with Trial Stakeholders should be able to identify risks and incorporate preventive/mitigating actions in the plan.
- The Clinical Data Manager should have attention on irregularities, deviations and should therefore be capable of foresee, identify and diagnose problems and is able of making relevant proposals for actions.
- The tasks of the Clinical Data Manager will, to a large extent, be performed independently and in accordance with Novo Nordisk SOPs, Novo Nordisk policies and the Novo Nordisk Way.
- M.Sc / B.Sc in Life Science or comparable degree in medicine, nursing, pharmacy, veterinary science or clinical information management or equivalent qualifications.
- Preferably 5-6 years of data management experience and the majority of this within Pharmaceutical Industry or Development.
- Preferably knowledge of Clinical Development and project Management
- Preferably experience in stakeholder management and presentation skills
Note : Freshers and candidate without Clinical Data Management experience need not apply.