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Diabetes Youth Families

Director, Key Opinion Leaders (KOL) – Field Medical Excellence

Diabetes Youth Families

Director managing clinical studies from initiation to completion at Insulet Corporation. Overseeing project teams and ensuring compliance with clinical study regulations.

Posted 6/9/2026full-timeActon • Massachusetts • 🇺🇸 United StatesSenior💰 $191,900 - $287,900 per yearWebsite

Tech Stack

Tools & technologies
Google Cloud Platform

About the role

Key responsibilities & impact
  • Oversee and coordinate the start-up, progress and closure of clinical research projects.
  • Guide and support the project team to ensure adherence with project objectives, timelines and budget.
  • Responsible for the design and implementation of pre-market and post-market clinical studies.
  • Develop and manage the project plan including a budget and timeline.
  • Facilitate the development of study protocols by coordinating input from various sources including literature, experts, and internal team members.
  • Select and manage investigational sites and clinical study vendors such as CROs and external laboratories.
  • Review project monitoring and site management plans and contracts.
  • Facilitate the development of study documentation including case report forms, informed consent forms, source documentation and study-specific plans for sound and thorough data to support the approval process or study objective.
  • Ensure monitoring is sufficient such that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements and fulfills the study objective.
  • Ensure study tracking and databases are maintained updated.
  • Pro-actively identify project specific issues and develop strategies and plans to address.
  • Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols.
  • Manage the clinical study report as well as the clinical portion of regulatory submissions.
  • Prepare scientific abstracts and manuscripts.
  • Coordinate and cooperate with third party vendors if applicable (e.g., Core laboratory, consultants, etc.).
  • Drive and lead project meetings and facilitate timely and accurate communication between the sites.
  • Keeps management team proactively informed about clinical study progress.
  • Review budgets on a regular basis to ensure all project costs are thoroughly tracked and controlled.
  • Performs other duties as assigned.

Requirements

What you’ll need
  • Bachelor’s degree in life/health sciences or related discipline, or equivalent; Master’s degree preferred
  • 4 – 6 year’s relevant clinical study management experience with emphasis in the diabetes industry and/or equivalent combination of education and experience
  • Medical devices experience preferred
  • CDE preferred

Benefits

Comp & perks
  • Medical, dental, and vision insurance
  • 401(k) with company match
  • Paid time off (PTO)
  • And additional employee wellness programs

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools
clinical researchproject managementstudy protocol developmentbudget managementdata managementregulatory submissionsclinical study report writingmonitoring and site managementcase report form developmentscientific writing
Soft Skills
leadershipcommunicationproblem-solvingteam coordinationstrategic planningtime managementadaptabilityresource managementstakeholder engagementproactive reporting
Certifications
Bachelor’s degree in life/health sciencesMaster’s degree in related disciplineCDE certification