Clinical Project Manager

The Clinical Project Manager is responsible for project management for clinical trials. Specific responsibilities include the following:

  • Manage all aspects of assigned clinical trials in accordance with FDA, GCP, and ICH guidelines. Create and oversee project timelines and budgets.
  • Contribute to the creation and review of essential trial documents such as protocols, informed consents, case report forms, and study manuals.
  • Evaluate, select, negotiate, contract and manage service providers (e.g. CROs, lab vendors). Develop and execute quality management plan.
  • Maintain trial level tracking, including enrollment, trial status, and SAE reporting.
  • Ensure trial delivery on time, on budget and with appropriate quality. Identify potential risks to budget and timeline.
  • Establish relationships with site personnel; lead investigator calls.
  • Manage study supplies and study drug ordering.
  • Oversee maintenance of the trial master file.
  • Review clinical data; work with programming team and medical on publications.
  • Travel to sites to oversee CRAs and assist sites with trial execution.
  • Coordinate with finance department for site payments.
  • Create SOPs and templates as needed.

Education and Experience

  • Bachelor degree ; BS in health related field preferred
  • Minimum of 5 years experience in clinical research in CRO, pharmaceutical or biotechnology environment
  • Forecasting and budgeting experience
  • Deep knowledge of regulatory guidelines including ICH/GCP
  • Strong attention to details and solid follow through.
  • Strong communication and organizational skills
  • Strong technology skills (e.g. Microsoft Excel, Word, Project, PowerPoint)

To apply for this position please submit your resume to careers@aileronrx.com.  Please include the job title in the subject line.

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