Act as point of contact from clinical operations for assigned trials and management of assigned projects from start up till close out

What are the key responsibility of the role?

• Plan study activities and timelines to share with stakeholders, set up tracking tools for assigned trials & assess progress as per pre-set timelines.
• Prepare & obtain approval for clinical trial budget and for any change in the budget during the study.
• Participate in vendor selection. Oversee & assess vendor performance, Vendor management.
• Co-ordinate finalization of IP label & requisition. Forecasting of IP requirement during the study and prepare IP requisition.
• Train study team on trial documents, processes & assigned SOPs.
• Arrange/Participate in kick-off meetings.
• Prepare/Review study plans & oversee compliance.
• Plan and conduct IM if required.
• Tracking of project finance & project milestones.
• Meet investigators and key opinion leaders for assigned trials.
• Drive subject recruitment for assigned studies and meet predefined timelines.
• Oversee & track regulatory & GCP compliance.
• Coordinate with cross functional groups for required deliverables

Key skills and requirement:

• M. Pharm / MSc and MBA will be preferred
• 12 to 15 years of experience as a clinical professional
• Minimum 3 years of clinical project management experience