Clinical Research Manager

This is a fully remote position, open to applicants in Belgium, +2 more countries.

📋 Description

• Serve as the line manager for clinical research associates and staff involved in trial monitoring.

• Plan, delegate, and oversee work assignments; evaluate performance and facilitate professional development for direct reports.

• Engage in the hiring process and allocate resources effectively for clinical research initiatives.

• Assign personnel to clinical studies according to their experience and training.

• Ensure adherence to clinical trial protocols in line with ICH/GCP, local regulations, and relevant SOPs.

• Collaborate with the Regional Clinical Operations Manager to uphold study timelines and maintain quality standards.

• Assist in study start-up and provide expertise specific to the country.

• Facilitate onboarding and training for new hires, while supervising their training plans.

• Oversee the quality of clinical work performed by assigned staff through regular assessments and evaluations.

• Review study start-up documentation, drug labels, informed consent forms (ICFs), and other relevant materials.

• Develop and evaluate recruitment materials and tools tailored for specific sites.

• Coordinate submissions to IRB/EC, ensure TMF completeness, manage site activation and enrollment objectives, and prepare for inspections.

• Contribute to feasibility assessments, site identification, selection, and evaluation processes.

• Conduct accompanied visits with Clinical Research Associates (CRAs) and evaluate their performance.

• Review visit reports, follow up on the resolution of issues, and escalate significant risks as necessary.

• Monitor workload and quality metrics through ongoing review and reporting.

• Identify site-related issues, propose corrective and preventive actions (CAPAs), and address any gaps.

• Contribute to the development of Clinical Operations strategies and performance enhancement efforts.

• Mentor and supervise junior staff and Clinical Research Associates.

• Conduct mid-year and year-end performance reviews for direct reports.

⛳️ Requirements

• A Bachelor’s degree (or equivalent) or higher in a scientific, medical, or healthcare-related field.

• A minimum of 5+ years of progressive experience in clinical operations within the biotech or pharmaceutical industries.

• Previous clinical trial experience, including management and leadership roles.

• Oncology experience is strongly preferred.

• At least 2 years of line management experience in the pharmaceutical or CRO sector is ideal.

• Capacity to work independently and manage multiple priorities in a fast-paced environment.

• Exceptional interpersonal and organizational skills.

• Proficient in both written and spoken English, as well as the local language.

• Skilled in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook.

• Willingness to travel up to 30–40% of the time.

🏝️ Benefits

• Committed to being an equal opportunity employer.

• Travel required up to 30–40% (travel allowance/expectation related to the role).