Overview

We are currently seeking a experienced Associate Director/Senior Clinical Project Manager.  The selected individual will serve as a member of our Project Management team to manage the timelines associated with the clinical development of compounds.  Thorough knowledge of the intricacies of clinical trails will be required-- this is a senior level role within our team.

 

Responsibilities include:

 

  • Coordination and project management responsibility for clinical trials, including organization of the trials, tracking and management of budgets and timelines
  • Work with Regulatory or other appropriate team members on responses to questions occurring during the regulatory approval process of a trial or during the trial (by competent authorities, Independent Ethics Committees (IECs)/Institutional Review Boards (IRBs)
  • Ensure that Clinical Trial Team follows SOPs (Standard Operating Procedures) and regulatory guidelines such as ICH GCP
  • Serve as the key contact for the contracted CRO, and ensure accurate and timely information flow within the Chimerix cross-functional team
  • Serve as primary reviewer for project level study plans and amendments (e.g., project plan, monitoring plan, risk plan) and provide/coordinate input on all other functional group plans (e.g., data management plan, medical monitoring plan, safety management plan)
  • Review regulatory submission packages (e.g., CTAs) from an operational perspective and provide feedback when appropriate
  • Oversee finance requirements for clinical trials such as accruals and forecasting
  • Experience in contributing to or creating clinical operations SOPs
  • International/multi-national trial experience
  • Review vendor payments/invoices to ensure they are in-line with agreed upon contracts
  • Experience reviewing site essential documents and IP release packets
  • Respond to investigative site questions and Clinical Research Organization (CRO) regarding protocol issues and implementation
  • Technical experience in reviewing labs manuals for use in clinical trials

Qualifications

  • B.S. or M.S. and a minimum of 7 years relevant experience managing the clinical development of a compound in a pharmaceutical company or CRO.  
  • At minimum 7 (but preferably 10) years’ experience in an operations, management, or monitoring position in a CRO or pharmaceutical company or an equivalent combination of experience and education.
  • Previous monitoring experience strongly recommended.
  • Experience with International or Multinational studies highly preferred.

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