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Clinical Study Manager

OVERALL RESPONSIBILITY:

The Clinical Study Manager is accountable for all aspects of the management of one or more clinical trials including trial start-up, conduct, and close-out activities. This position provides an opportunity to join a rapidly growing development organization and contribute substantially to the successful implementation of clinical studies across a number of therapeutic indications.

KEY TASKS AND RESPONSIBILITIES:

  • Proactively manage project-level operational aspects of clinical studies, including management of study timelines, budget, resources and vendors.
  • Provide efficient updates on study progress to the Leadership Team with respect to study progress, timeline and budget management, quality standards and risk mitigation.
  • Lead sponsor study startup processes, including conduct of kick-off meetings, site and vendor training, vendor and site selection, vendor contracts and site Clinical Trial Agreements and budgets.
  • Ensures country and site selection meet study requirements
  • Vendor identification and management (e.g., CROs, IVRS, Reading Centers, etc.), including participating in negotiation of vendor scope of work, budgets, performance management, issue resolution, and quality assessment
  • Ensures availability of clinical and non-clinical supplies
  • Provides input to clinical regulatory documents (IB, CSR, IND updates)
  • Participates in the development and testing of clinical systems (laboratory, EDC, IVRS, etc.)
  • Maintains or oversees the maintenance of the Trial Master File
  • Author/co-author protocol in collaboration with the Project Physician and other stakeholders
  • Identify, address and communicate quality and compliance concerns
  • Provides regular study status updates and as requested
    Communicates effectively with internal and external study personnel (investigative staff, vendors, etc.)
  • Provides study-specific direction, mentoring and management to other staff as appropriate
  • Ensures trial adherence to ICH/GCP/local regulations

SKILLS AND ATTRIBUTES:

  • Ability to work independently in a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical.
  • Willingness and ability to travel domestically and internationally, less than 30 % of the time.

EDUCATION AND EXPERIENCE:

  • Bachelor’s degree in Life Sciences, Nursing Licensure or Pharmacy.
  • Four or more years of clinical operations experience, with increasing levels of responsibility, in the Pharmaceutical, Biotechnology or CRO industry.
  • Five or more years of clinical project management experience at a sponsor or CRO company is preferred, and experience in early phase trials (Phase I-II).

If interested, we would welcome a cover letter and CV sent to careers@axcellahealth.com No phone calls please, and only those we will be following up with, will receive a reply.