Senior – Manager

Clinical Operations
Mumbai
Posted 9 months ago

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

 

 

Job Features

Job CategoryClinical Development
Job CategoryPartnerships & Portfolio Strategy

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