Clinical Operations Director overseeing patient care in Oncology Clinics at Duke Health. Leading clinical management and strategic planning for Wake County Oncology Clinics.
DF
Hybrid Senior Clinical Project Manager – Hybrid
Posted last month
About the role
- Senior Clinical Project Manager managing clinical and pre-clinical projects for a medical device company. Collaborating with cross-functional teams to ensure project milestones are met and regulatory submissions completed.
Responsibilities
- Manage and execute complex clinical and pre-clinical projects from study initiation through closeout under the guidance of the Director, Clinical Affairs.
- Serve as the liaison between clinical and R&D, marketing, operational departments, investigators, study coordinators, advisors, and key opinion leaders.
- Manage CRO and other outside clinical vendors and/or consultants.
- Management of study budgets and timelines.
- Provide day-to-day direction and manage workload of project resources (CRAs, Data Managers, etc.).
- Development of investigator brochures and study subject enrollment enhancement materials.
- Development of investigational plans and clinical protocols.
- Qualification and screening of investigational sites.
- Negotiate investigational site contracts.
- Oversee investigational site training and investigator meetings.
- Oversee clinical study monitoring.
- Manage final study reports.
- Work with Regulatory Affairs to manage US and international regulatory submissions for the conduct of clinical studies and the approval of new products.
- Manage the preparation of pre-IDE and IDE submissions and clinical study-related interactions with the FDA.
- Development of standard operating procedures in compliance with US and Intl GCPs.
- Execute on clinical program strategy as directed by Director, Clinical Affairs.
- Manage KOL relationships.
- Drive clinical study communication to cross functional teams.
Requirements
- Bachelor's Degree in Biology, Health Sciences, or related field of study.
- Equivalent work related experience acceptable in lieu of degree and/or a combination of education and experience.
- 5-8 years of demonstrated experience in clinical study management to support medical device regulatory approval applications.
- Diabetes experience highly desirable.
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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