Hybrid Senior Clinical Project Manager – Hybrid

at Diabetes Youth Families

• Job title: Senior Clinical Project Manager – Hybrid
• Job type: Full Time
• Experience level: Senior
• Salary: $137,400 - $206,100 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Acton, United States

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