Clinical Project Manager

Job Description

We are currently seeking a Clinical Project Manager to join our growing team. In the role you will be responsible for:

  • Feasibility Assessment
  • Site Selection Strategy and Finalization of sites
  • Develop, negotiate, and finalize Investigator Contracts
  • TMF setup and maintenance
  • Regulatory submission tracking and oversight
  • Monitoring plans and strategy
  • IM coordination, presentation, and conduct
  • SIV plans and conduct
  • CTMS oversight on completion and updates wherever necessary
  • Identify risks to protocol quality
  • Site close out management and tracking
  • Participate in Handover meetings and Kick Off meetings
  • Development of PMP
  • Development of study specific plans (Risk Management Plan; Monitoring Manual)
  • Set up and management of study specific trackers
  • Resource allocation
  • Facilitate training (Therapy area, Project specific, and General)
  • Development and implementation of project budget tracker
  • Participate in client meetings
  • Participate in internal review meetings (ORM, Project reviews)
  • Conduct periodic project reviews
  • Conduct post site visit de-briefs
  • Critical issue management and escalation
  • Approval of payment to sites (National/international)
  • Project level communications
  • Provide oversight to project (maintaining quality and timelines of deliverables)
  • Participate in client QA assessments
  • Implement Quality initiatives across projects
  • Conduct accompanied site visits (Quality and Training)

Desirable Skills and Experience

  • Clinical Trial Monitoring Onsite in Phase II-IV studies

Bangalore, India

Life Sciences Graduate

Manager

Clinical Research

Full Time

10 Aug 2021