Division
: Medical Research Division
Location
: Mumbai
Job
Profile :
- Design of Phase I-IV clinical study documentation
- Medical and safety monitoring of Phase I-IV clinical studies
- Write protocol synopsis and develop protocols for Phase III registration, IV, PMS, Observational studies, surveys, other clinical projects as well as India only WWD studies in consultation with product management/physician and Asia AfME Biometrics Center (AABC).
- Review and interpret generated data and write final reports for locally sponsored studies when required.
- Design informed consent form/patient information sheets
- Conduct pre-study visits on proposed clinical trial sites or supervise team members delegated to perform this task.
- Collaborate with CSM and training Coordinator in providing training to in-house project teams (CRAs, project secretaries/assistants) and site project teams on clinical research methodology, study design, protocol, CRFs through on-site coaching, training sessions and workshops.
- Assist in planning, organizing and preparing Investigational New Drug applications.
- Participate in conducting Investigators’ Meeting and/or initiation visits prior to study start.
- Contribute to preparation of local clinical development plans for products within assigned therapeutic area.
- Assist project managers in compilation of feasibility studies for potential studies from WWD/PGP India
- Collaborate with CSM and training Coordinator in providing training to in-house project teams (CRAs, project secretaries/assistants) and site project teams on clinical research methodology, study design, protocol, CRFs through on-site coaching, training sessions and workshops.
- Manages budgets to ensure short and long term research and development.
- Conduct training sessions on medical/therapeutic areas for the project team members.
- Continuously evaluate technology developments for evaluating and adopting innovations in training.
- Demonstrate and promote Pfizer global value system across all interactions.
Qualification & Experience
:
- M.D.
- Exposure to clinical trial design & methodology will be an added advantage.
Date
of Posting : 09/09/2005

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