Clinical Research Associate/ Clinical Site Manager

Clinical Research Associate / Clinical Site Manager

We are seeking an experienced Clinical Research Associate (CRA) or Site Manager to manage and support the execution of clinical trials across multiple sites in Europe, including the UK, Spain, Italy, Germany, France, and Netherlands. The role will involve high travel, site management, data collection, and protocol setup across a variety of surgical settings, with a strong focus on data management and clinical operations.

Location: Europe (UK-based with high travel to sites in Spain, Italy, Germany, France, Netherlands)

Travel Requirement: High (to 5-6 sites across Europe)

Key Responsibilities

• Site Management & Monitoring:

  Oversee the execution and monitoring of clinical trials at 5-6 sites across Europe, ensuring trial compliance with GCP, regulatory guidelines, and clinical protocols. Manage site startup activities, monitor progress, and perform regular site visits to ensure high‑quality data collection and patient safety. Conduct regular site training and follow‑up visits to ensure adherence to study protocols.

• Data Management:

  Oversee and ensure accurate data entry into relevant databases, including data verification and video management from sites. Assist with the setup of clinical protocols, monitoring data quality, resolving discrepancies, and collaborating with the data management team to ensure data accuracy, completeness, and compliance. Prepare and assist with data demo sessions as needed.

• Clinical Research & Medical Tech Experience:

  Demonstrate knowledge of medical technology, particularly operating‑room settings, including laparoscopic and robotic surgery. Experience in colorectal surgery, soft tissue, general surgery, and gynaecology. Familiarity with laparoscopy, minimally invasive techniques, and robotic surgery is essential. No orthopaedic or catheter lab experience required.

• Regulatory Compliance & Support:

  Work closely with clinical teams to ensure regulatory compliance, patient safety, and trial integrity across all study sites. Support preparation of required documentation, including protocol amendments and clinical trial reports. Ensure sites remain inspection‑ready with a proactive approach to quality control and audit preparation.

Skills & Experience

• Clinical Research Experience:

  Previous experience as a CRA, Site Manager, or similar role in clinical research and trial management. Experience with data management, including data entry, quality control, and study setup. Background in medical technology or clinical trials involving medical devices is a plus.

• Surgical & OR Experience:

  Hands‑on experience or familiarity with operating‑room environments, specifically in laparoscopic, robotic surgery, and other minimally invasive techniques. Experience in colorectal surgery, soft tissue, general surgery, and gynaecology is highly desirable.

• Language & Communication Skills:

  English proficiency required for communication with sites across Europe. Knowledge of Japanese would be an asset but is not essential.

• Flexibility & Travel:

  High travel across European sites; flexibility and independent workload management are essential. Ability to take ownership of trial progress with minimal supervision.

Additional Information

• Other Details:

  This is not a super-fast process; we are looking for someone with the right experience who can take on a high‑visibility, highly flexible role. The role will primarily involve data management, with the opportunity to demonstrate clinical tech in surgical environments. Budget is available for the right candidate, but the timeline is not short, allowing careful selection. We prefer a gentle approach to avoid overwhelming sites.

Seniority level

Associate

Employment type

Full‑time

Job function

Project Management

Industries

Pharmaceutical Manufacturing and Biotechnology Research