CH|EN
Select your region & language
Our content and services may vary by location.
CH|EN
Back
Smiling employee in a conversation with a colleague in the office
Smiling employee in a conversation with a colleague in the office
ID: 139474

Clinical Project Manager

  • MedTech
  • Asap
  • Clinical Trial Management, CRO & Vendor Management
  • K-Recruiting GmbH
Contact:

Julius Strack

+49 89 1890998-614

julius.strack@k-recruiting.com

Overview

Availability
Asap, 5 days/week, on-site & remote
Qualification
Medical background
Language Skills
English (Fluent)
Relevant Expertise
Relevant Expertise Clinical Trial Management, CRO & Vendor Management, Regulatory Submissions, PMS & RWE Strategy, Clinical Protocol Design, Budget Oversight, EU MDR, PMCF, CER, FDA, PMA, 510k, AI-Based Diagnostics, Class III Devices, SaMD

Key-Facts

  • Clinical Development Manager with a proven track record in managing global MedTech and SaMD trials, ensuring compliance with FDA and EU MDR regulations, and leading cross-functional teams to success.

  • Expert in clinical trial management, regulatory submissions, and budget oversight, with a focus on AI-based diagnostics and Class III medical devices, delivering high-quality outcomes across multiple geographies.

  • Skilled in developing and executing clinical protocols, managing vendor relationships, and ensuring audit readiness, with extensive experience in NHS, academic, and digital health collaborations.

  • Adept at authoring regulatory documents, conducting systematic literature reviews, and maintaining PMS/PMCF strategies to ensure ongoing device safety and performance tracking.

Extract from previous activities

2023 – 2025

Senior Scientific Manager

  • Led international clinical research programmes, including FDA and EU MDR studies, covering pivotal, precision, and post-market trials across multiple geographies

  • Oversaw study operations from feasibility through to closeout, including regulatory submissions, country/site selection, and IRB/ethics approval processes

  • Managed vendor relationships, study budgets, timelines, and contract deliverables to ensure consistent, high-quality outcomes

  • Directed cross-functional teams including data management, medical writing, QA, and regulatory affairs to deliver compliant and audit-ready trial documentation

  • Conducted systematic literature reviews to support Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up (PMCF) activities

  • Developed and maintained PMS/PMCF strategies to ensure ongoing device safety and performance tracking

  • Authored and revised Standard Operating Procedures (SOPs), supporting continuous process improvement and inspection readiness

2021 – 2023

Clinical Project Manager

  • Managed multiple global clinical studies for AI-based medical devices, leading cross-functional teams across clinical operations, regulatory, and data science

  • Conducted feasibility assessments, site selection, and site start-up for international trials aligned with FDA and UKCA requirements

  • Oversaw regulatory submissions, study budgets, CRO/vendor deliverables, and performance metrics to ensure study timelines and quality objectives were met

  • Authored key regulatory documents, including Investigator Brochures and protocols, in compliance with GCP and FDA expectations

  • Developed SOPs, CRFs, and QA procedures to standardise trial execution and maintain data integrity

  • Provided mentorship to junior CPMs and led collaborative efforts with regulatory teams to prepare Clinical Evaluation Reports (CERs) and submission packages

2018 – 2021

Clinical Trial Manager

  • Headed the Trial Management Unit (TMU), providing oversight and strategic leadership for a team managing multi-specialty clinical trials

  • Delivered end-to-end trial management including REC, HRA, and MHRA submissions for CTIMPs and device trials, ensuring compliance with ICH-GCP

  • Led budgeting, investigator negotiations, site initiation, monitoring, and stakeholder communications across industry and academic trials

  • Designed essential study materials (protocols, CRFs, databases) and mentored junior researchers in trial execution and regulatory documentation

  • Collaborated with NHS clinicians, universities, and commercial partners to implement high-impact research in cardiology, dermatology, oncology, and infectious disease