Clinical Project Manager

2 days ago

Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time
Job Title: Clinical Project Manager

We are seeking a highly skilled Clinical Project Manager to lead our pivotal development programs and oversee all operational aspects of phase I-IV US-based or global clinical trials.

Key Responsibilities:
  • Lead pivotal development program(s) and manage all operational aspects of phase I-IV US-based or global clinical trials.
  • Act as primary point of contact for internal and external teams for planning, conduct, and reporting of assigned trials.
  • Participate in vendor selection process with assigned PMO representative, including proposal development, bid-defense process, and contract review.
  • Oversee study start-up activities of CROs, including site identification, feasibility, site selection, contract negotiation, and clinical study agreement finalization.
  • Manage and assess vendor performance, including timelines and deliverables.
  • Develop team and process for carrying out start-up activities for some sites in the US for faster FPI in a global or US-only study.
  • Prepare and review budgets for studies managed in-house and review professional fees and pass-through costs for CROs, SMOs, investigators, and vendors.
  • Support Functional Head in preparation of annual studies budget and department budget.
  • Manage and track study budget, project milestones, and timelines throughout the life of the study and perform contract reconciliation at study end.
  • Plan study activities and timelines and share with stakeholders, set up tracking tools for assigned trials, and assess progress as per pre-set timelines.
  • Coordinate finalization of IP label and requisition, forecasting of IP requirement during the study, and prepare IP requisition.
  • Prepare and review study plans for in-house/outsourced studies, train study team on trial documents, processes, and assigned SOPs.
  • Plan and facilitate vendor kick-off meetings and investigator meetings for study.
  • Meet investigators and key opinion leaders for assigned trials.
  • Drive subject recruitment for assigned studies and meet predefined timelines.
  • Prepare and implement quality control plan in assigned studies and ensure that clinical studies (in-house or outsourced) are in compliance with ICH-GCP, SOPs, and applicable regulations.
  • Coordinate with cross-functional groups for required deliverables.

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