Senior Clinical Project Manager (Hybrid)

Insulet Corporation•Acton, MA

36d•Hybrid

About The Position

This position will manage and execute complex clinical and pre-clinical projects from study initiation through closeout under the guidance of the Director, Clinical Affairs. The Sr. Clinical Project Manager will serve as the liaison between clinical and R D, marketing, operational departments, investigators, study coordinators, advisors, and key opinion leaders in order to ensure that all targets and requirements are met. In addition, this role will contribute to and manage study proposal review, protocol development, and vendor selection and management.

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.
Direct experience in the management of CROs and other service clinical research service providers.
Excellent attention to detail and accuracy.
Solid understanding of GCP.
Proficient in the following computer software applications: MS Office products and other technology to document data and provide reporting.
Exceptional interpersonal skills.
Strong organizational skills.
Strong communication skills (written and verbal).
Ability to effectively communicate both internally and externally.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and correspondence.

Nice To Haves

Diabetes experience highly desirable.

Responsibilities

Management of 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
Performs other duties as required.