Clinical Project Manager (Hybrid)

Job Title:                       Clinical Project Manager

Department:                  Clinical and Medical Affairs

FLSA Status:                Exempt

Position Overview:

The Clinical Project Manager is responsible for managing and executing clinical studies from study initiation through study closeout, as well as assuring compliance with regulatory and quality procedures and standards. Lead the planning, execution, and reporting of human factors studies and usability evaluations according to medical device regulations, as well as human factors vendor selection and oversight. Support other related corporate initiatives, as required.

Responsibilities:

• Coordinate and supervise study execution and contract management for usability and user preference studies, formative, and summative human factor studies.
• Review and approve protocols, study designs and reports for clinical and human factors studies.
• Work with Regulatory Affairs to manage US and international regulatory submissions for the conduct of clinical studies and the approval/clearance of new products. Manages all aspects of product launch for Product Support and Customer Care
• Collaborate cross-functionally in preparation of documents for the Design History File and for regulatory filings.
• Proactively stay abreast of the latest regulations and GCP (Good Clinical Practice)
• Support management of CRO and/or other outside clinical vendors.
• Co-manage study timelines and budgets.
• Drive clinical study communication to cross-functional teams.
• Support review of data analysis and interpretation of clinical information.
• Compile and summarize post market clinical information to support regulatory documentation.
• Support other tasks related to Insulet-sponsored clinical trials.
• Perform other duties as required

Education and Experience:

• B.S. or B.A. (preferably in a Life Science field) or an equivalent combination of education and experience.
• 5+ years of medical device or drug related clinical experience (with a minimum of 2 years direct project management experience preferred).
• Endocrinology experience highly desired.
• Must have analytical skill, be detail oriented and have good interpersonal skills.
• Knowledge of agency guidelines and requirements.

Skills/Competencies

• Excellent written and effective verbal communication skills.
• Proficient project management skills.
• Ability to prioritize multiple timelines and tasks.
• Ability to communicate at all levels of an organization.
• PC skill, word processing, spreadsheet, database.
• Internet search and utilization.
• Flexible and able to work in a fast-paced environment.
• Team player

Travel Requirements (if applicable):         

• Estimated travel (domestic and international) is approximately 10% per year.

Ideal candidate will be able to work hybrid from our Acton, MA or San Diego, CA offices.

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 3x/week; may work remotely other days). #LI-Hybrid 

Additional Information:

The US base salary range for this full-time position is $99,300.00 - $148,950.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

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 cont