POSITION RESPONSIBILITIES :

The Medical Monitor will perform the following activities:

- Design develop prepare and initiate clinical study protocols and required documentation in compliance with project plans federal/DCGI regulations GCP and good medical practice

- Participate in the selection of clinical investigators; provide proper investigator profile for study. Visit selected sites to trouble-shoot train/retrain staff- if needed.

- Assist the client in planning the overall strategy for clinical drug product development as and when required.

- Provide medical supervision and training for project teams - study investigational sites other involved organizations- for the understanding and delivery of study protocol.

- Provide medical and scientific input to review of clinical data- patient medical safety data and laboratory values; maintain an ongoing assessment of the safety profile- and efficacy data

- Provide medical surveillance on Serious Adverse Event (SAE) reporting- follow- ups- including after hours coverage of medical emergencies.

- Participate in the planning- writing and review of Clinical Study Reports- regulatory updates and submissions.

- Continuing research of new scientific developments.

- Analyze and interpret study data and prepare reports.

- Serve as the primary medical contact with academic expert collaborators and opinion leaders.

- Participate as an active member of multidisciplinary teams to successfully achieve corporate goals. Specific responsibilities include interacting with project management and clinical operations to provide estimate for operational budgets and assess laboratory requirements.

- Any other duties assigned by the supervisor in the department.

Education Qualification : MBBS/MD(Pharmacology)

Location : Delhi NCR/ Mumbai

Experience : 4 - 7 years

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