Clinical Project Manager

Role:

The Clinical Project Manager drives the clinical development plan and deliverables by providing expert operational oversight and guidance on multiple clinical studies (phase I through IV) through CRO and vendor management, review and monitoring of work performed, metric compliance, and risk identification and mitigation. The CPM possesses an expert understanding of the overall Clinical Development plans and how the studies align within the corporate objectives. The CPM executes clinical studies by leading study operational strategy and planning and overseeing execution of clinical studies. The CPM will demonstrate the ability to manage multiple studies simultaneously and handle complex tasks.

Responsibilities:

  • Oversees and manages daily clinical operations, including management of vendors (e.g., CRO), Heat clinical staff and coordination of activities
  • Manages the build and development of study databases including EDC, IxRS, Safety Management Systems
  • Tracks and prepares study-specific data utilizing clinical trial management systems, databases, spreadsheets, and other tools
  • Participates in the review of clinical data, analysis tables, listings, and figures (TLFs) and patient profiles for data consistency and accuracy
  • Accountable for meeting clinical trial objectives, milestones, and deliverables
  • Identifies and manages risks, using appropriate documentation, such as RACI, and risk management tools
  • Reports trial progress to management team, prepares and distributes documents for study specific meetings
  • Contributes to study documents such as the protocol, amendments, informed consent forms (ICFs), case report forms (CRFs), clinical study reports (CSRs), Investigational New Drug Application (IND) annual reports, Periodic Safety Update Reports (PSUR), Investigator's Brochure (IB) and New Drug Application (NDA)
  • Maintains and manages internal clinical trial master files (TMF) and documents
  • Assists in the identification, qualification, and management of third-party vendors, including development of Request for Proposals (RFPs), scope of work (SOW), and vendor specifications documents
  • Ensures that CRO and Investigators meet Serious Adverse Event/Serious Adverse Drug Reaction reporting obligations
  • Conducts financial planning activities, reviews contracts and budgets, submits timely and accurate invoicing, oversees the administration of investigator payments, and analyzes overall project financial health
  • Identifies and negotiates out of scope project work and executes change orders where needed
  • Participates in investigator meetings and follow up
  • Coordinates and plans for the availability of non-clinical supplies necessary to meet study requirements
  • Ensures Investigational Product (IP) needs for clinical studies are available and managed appropriately
  • Coordinates activities related to audit findings and/or identification of significant site noncompliance
  • Coaches, mentors, and trains project team members
  • Serves as a point of escalation for major issues and conflicts, leading problem solving and resolution efforts

Qualifications:

  • An undergraduate degree (BA/BS) in a health science or biologic science
  • A minimum of 5 years of pharmaceutical/biotech industry experience in planning and managing clinical trials
  • Significant experience with responsible roles in the conduct and management of Phase I - III clinical trials
  • Good working knowledge of medical terminology, physiology and pharmacology and an excellent knowledge of applicable U.S., international regulations and guidelines
  • Excellent oral and written communication, organizational and planning skills, and ability to manage budgets
  • Detail-oriented, a self- starter and comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment

Location:

  • This is a primarily office-based position associated with our headquarter office in Morrisville, NC. For the time being, this role will be able to function remotely during the pandemic but is subject to change as needed in accordance with company safety guidelines

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc