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Clinical Project Manager

Job ID: 212825

Location: Foster City, California , US, 94404

Summary:

Responsible for executing on clinical strategies to deliver successful operational outcomes across one or multiple clinical trials

Project Details:

  • Assist with the evaluation, selection and management of external vendors to ensure successful clinical trial implementation and execution
  • Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with GCP and ICH guidelines
  • Work closely with the Program Lead to coordinate, track, and manage all logistics in support of the clinical Program
  • Accountable for managing study budgets, including invoice and PO management/reconciliation, month end actuals and accruals in support of the Program Lead and Finance
  • Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
  • Assist with authoring of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary
  • Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials
  • Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed
  • Assist with development and implementation of policies and standard operating procedures (SOPs) to be used in Clinical Operations

Job Experience:

  • BA/BS (preferably in industry or healthcare of science field) with 3-5 years progressive experience in clinical operations
  • Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance
  • Ability to handle a high volume of highly complex tasks within a given timeline
  • Ability to lead a cross-functional team in a matrix environment
  • Extensive experience managing clinical programs, CROs, budgets, and timelines required
  • Strong working knowledge of MS Project and developing Gantt charts
  • Excellent interpersonal and negotiation skills
  • Strong verbal and written communication and presentation skills
  • Proactively seeks out and recommends process improvements

Hourly Rate: 72.25-93.5

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