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

ATS Keywords

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Hard Skills

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

Tools & Technologies

clinical trial management systemsdata tracking databasesCRO managementFDA regulationsGCP guidelinesICH guidelinesinvestigational product managementthird-party vendor coordinationliterature review toolsproject tracking software

Certifications & Qualifications

Bachelor’s degree in life/health sciencesMaster’s degree in related disciplineCDE certification

Industry Keywords

clinical study managementdiabetes industrymedical devicespre-market studiespost-market studiesinvestigational sitesclinical study vendorsstudy documentationregulatory complianceclinical research protocols

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