Senior Clinical Project Manager (Hybrid)
Position Overview:
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.
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.
Education and Experience:
• 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.
Skills/Competencies:
• 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.
Physical Requirements:
• This position requires some travel up to 10-15% of the time.
Hybrid:
NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office). #LI-Hybrid
Additional Information:
Compensation & Benefits:For U.S.-based positions only, the annual base salary range for this role is $137,400.00 - $206,100.00This position may also be eligible for incentive compensation.We offer a comprehensive benefits package, including:• Medical, dental, and vision insurance• 401(k) with company match• Paid time off (PTO)• And additional employee wellness programsApplication Details:This job posting will remain open until the position is filled.To apply, please visit the Insulet Careers site and submit your application online.Actual pay depends on skills, experience, and education.
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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