Job Title: Clinical Project Manager
Location: This is a remote opportunity.
Responsibilities:
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.
- 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.
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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Quality Assurance -
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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