Clinical Trial Manager

For a pharmaceutical company focused on the development and production of a wide range of medicines and vaccines, with a specific focus on chronic and complex conditions, we are seeking an experienced Clinical Trial Manager.

The clinical Trial Manager will be the operational head for clinical trials in an assigned country. You will be fully accountable for the strategic planning, management, and performance of all studies, from start to finish. You will be the key link between global and local teams, ensuring trial conduct meets our standards and regulatory guidelines.

Main responsibilities:

• Study Strategy & Start-Up: You will lead the country's strategic planning and start-up activities. This includes creating local recruitment strategies, selecting the best sites, and ensuring a smooth and timely launch.
• Operational Management: You are fully responsible for the study's performance at a local level. You will drive progress, manage the trial's tools and timelines, and create risk mitigation plans to address any issues that arise.
• Budget Ownership: You own and manage the country's study budget. You'll work to optimize financial resources, prepare budget forms, and proactively flag any financial risks to leadership.
• Communication & Collaboration: You will be the main point of contact for all local and global teams, including investigators, site staff, and vendors. You'll lead meetings and ensure all parties are aligned to achieve common goals.
• Quality & Compliance: You are accountable for data quality, patient safety, and ensuring the study remains fully compliant with GCP and other regulations. You will also prepare for and support audits and inspections.

Requirements:

• Bachelor’s (or higher) degree in nursing, biochemistry or related natural science
• Experience in clinical research is mandatory, in combination with experience in project management and certain time as field monitor or site-coordinator. Solid knowledge of clinical development process and relevant therapeutic/disease area(s)
• Strong skills in Project Management
• Problem-solving and risk-management skills in a clinical study environment
• Data analytic skills and use of digital tools, platforms and systems
• Change management skills
• Interpersonal skills with ability to create and foster trustful relationships with several internal and external stakeholders
• Languages: Fluent in English and country language (FR & NL).

We offer you an attractive salary package and a contract with Randstad Professional. Your benefits as a consultant:

• Gross salary dependent on your personal situation
• Additional net allowance of €80 per month, on top of your net salary
• The possibility to opt for a company car (under conditions) with a fuel card (also for private use) or a mileage allowance
• Meal vouchers
• Ecocheques of €250 per year
• Holiday pay and a 13th month
• 12 extra days off per year
• Hospitalization insurance with DKV
• Pension savings
• In addition, we also offer numerous training courses, fun activities, opportunities for growth, etc., to guide you throughout your career.