Deputy General Manager

To Support in Development of Clinical Trial Protocol
- Review of published literature
- Review of pre-clinical & BA/BE reports
- Preparation of drat protocol
- Co-ordinate review of protocol with Medical Services & other department
- Preparation of appendices, Patient diary, activity schedule
Development of Informed Consent Document
- Review protocol
- Preparation of Draft ICD and co-ordinate review
- Translation and back translation of ICD as and when required
Updating Clinical Trial SOPs
- Updating Clinical Trial SOPs
- Train Medical Service Department personnel on updated SOP
- Design logs and forms, index, separators
Clinical Trial Operations:
- Preparation of protocol related presentation for SEC meeting
- Protocol training to study personnel
- Site selection and feasibility
- Co-ordination for site documents like: CDA, Feasibility Questionnaire, IU etc.
- To support investigators for EC submission and query resolution
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