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
• To Support in Preparation & Conduction of Site Initiation Visits
• Monitoring of Clinical Trial Sites
• To Support in Preparation & Conduction Site Closeout Visits
• Site Visits: SIV, SMV, SCV
• Review and approval of site visit reports
• Development and Maintenance of Trial Master File
• Site follow up for patient recruitment and pending action items

To Support in Development & Compilation of Clinical Study Report

To Support in Pharmacovigilance Function

• Knowledge about Pharmacovigilance system
• Medical Review of ICSRs
• Knowledge about MeDRA and WHO-DD
• Review of PSURs / RMP etc.