Mix Talent

Clinical Project Manager - Remote

Mix Talent Austin, TX

Job Title: Clinical Project Manager

Location: This is a remote opportunity.

Responsibilities:

  • Manage all clinical aspects of studies under the supervision of clinical operations senior management.
  • Ensure all clinical trials comply with applicable SOPs, company policies, and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of named products.
  • Oversee the successful execution of studies and/or multiple studies within a program.
  • Responsible for the resource management of studies, including ongoing assessment of resource needs and optimal deployment of resources to support a fluid workforce. Manage a team of clinical monitors, including site initiation visits and closeout visits.
  • Coach direct reports on their performance, development, and career interests.
  • Provide input into strategic and operational short- and long-range therapeutic area/functional area plans as appropriate, and support alignment and communication to other team members upon implementation.
  • Oversee operational feasibility, study timelines, budget, and metrics.
  • Organize and lead study-related meetings (Study Team Meetings, Investigator Meetings, etc.).
  • Participate in the selection and management of contract research organizations (CROs)/vendors, including the development of requests for proposals (RFPs).
  • Use all available tools to track, oversee, and communicate on program status to all key stakeholders.
  • Collaborate with cross-functional teams and external vendors to drive trial execution.

Qualifications:

  • Educational Background:
    • BA / BS / RN: With 8 or more years of relevant clinical or related experience in life sciences.
    • MA / MS / PharmD / PhD: With 6 or more years of relevant clinical or related experience in life sciences.
  • Experience:
    • A minimum of 4 years' cross-functional study management or related leadership experience in life sciences, including multiple years' experience managing study management or project teams.
    • Experience managing direct reports.
    • Proven ability to successfully start-up, manage, and close out clinical studies, including authoring clinical study and regulatory documentation and SOPs.
    • Experience in gastroenterology and respiratory products preferred.
  • Skills and Competencies:
    • Advanced knowledge of one or more disease or therapeutic areas, as evidenced by independence in designing, implementing, and managing study team plans, deliverables, and resource management.
Job Identifier: #4851

  • Seniority level

    Mid-Senior level
  • Employment type

    Full-time
  • Job function

    Quality Assurance
  • Industries

    Biotechnology Research and Pharmaceutical Manufacturing

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