Principal Clinical Research Specialist

Medtronic

6d•Remote

About The Position

We are seeking a Principal Clinical Research Specialist to serve as a Study Manager supporting Pelvic Health clinical studies across Europe, including the UK, France, Belgium, and Germany. This role offers the opportunity to lead and shape the execution of meaningful clinical research that directly impacts patient care. As a Study Manager, you will take ownership of multi-site studies from start‑up through close‑out, working closely with investigators, cross‑functional partners, and external vendors to deliver high‑quality, compliant clinical evidence in a dynamic, global environment. This is a remote position that will partner closely with the Pelvic Health clinical team based in Minneapolis, MN. Travel up to 20% is expected to support site engagement and study execution across Europe.

Requirements

Extensive experience managing multi‑site, international clinical studies within the medical device or regulated healthcare industry, with demonstrated Study Manager–level accountability
Strong working knowledge of ICH‑GCP, ISO 14155, EU MDR, UK clinical research requirements, and applicable country‑specific regulations, with hands‑on application in study execution
Prior experience authoring and reviewing clinical study documentation, including protocols, CRFs, and clinical reports, and interpreting clinical data to support evidence generation and regulatory needs
Demonstrated ability to manage clinical trial operations, including vendor and site oversight, clinical supplies, budgets, and cross‑functional collaboration in a global environment
Strong communication, stakeholder management, and organizational skills, with the ability to work independently in a remote role

Responsibilities

Lead the design, planning, and execution of registered and non‑registered Pelvic Health clinical studies, including authorship of clinical protocols, case report forms, and related study documents
Provide end‑to‑end operational oversight of multi‑site clinical trials, ensuring compliance with SOPs, GCP, and country‑specific regulations, and supporting clinical trial budget development as needed
Interpret and oversee clinical investigation data to support medical evidence generation, regulatory submissions, and new or expanded device applications
Manage key operational components of clinical studies, including clinical supply operations, site and vendor selection, and cross‑functional coordination with internal and external partners
Serve as a clinical research representative within the assigned region, building strong relationships with investigators, customers, and regulatory authorities, while driving local evidence dissemination and incorporating regional feedback into study execution