Junior Clinical Data Associate Full-time Job
Nov 30th, -0001 at 00:00 IT & Telecoms Chennai 13 views Reference: 2295Job Details
Clinical Data Manager is responsible for planning, conducting and managing of all aspects of data management for a clinical trial according to the client specifications, protocol, project plan, Data Management Plan, relevant GCDMP guidelines, regulatory requirements and SOPs. 1. Determination of project feasibility from a data management perspective. Understand the requirements of the project agreement and scope to ensure that Novotech performs these services as required. If full service then collaborate with PM to ensure appropriate mitigation and contingencies are initiated 2. May act as Project Manager for stand-alone data management projects. 3. Participates in project team meetings as required 4. Input into the preparation of RFPs in liaison with BD and the clinical team. 5. Liaison with the project team and client for preparing and maintaining Data Management Plans. 6. Responsible for all aspects of data management 7. Supervision and training support for junior and contract Data Management staff as required. 8. Adherence to company Quality Policy and procedures as applicable to carrying out job responsibilities. 9. Active contribution in Data Management process improvement including identification of and participation in process improvement initiatives. 10. Perform accurate study financial projections and maintain monthly project financials. 11. Ensure changes in scope are identified and actioned accordingly 12. Provide expert assistance and input into internal cross-functional projects including clinical research and regulatory affairs, as assigned. 13. Project management of internal IT-based company projects as assigned (e.g. intranet development, client database applications etc.). 14. Active contribution to company business development initiatives, including involvement in the implementation of data management plans for business development in the company in general. 15. Participation in industry fora (conferences, professional association committee work, etc) as a means of professional development as well as promotion of Novotech's image in industry