Project Compliance Manager

In this role, you’ll be instrumental in maintaining compliance with Julius Clinical and regulatory quality standards. Your responsibilities will range from developing project-specific clinical trial processes to conducting compliance checks and providing training to project teams. You’ll serve as a primary point of contact for addressing any procedural issues, fostering collaboration among stakeholders, including sponsors, and contributing to continuous process improvement.

The job asks you to perform in a calm and structured way during challenging circumstances.

• Develop project specific clinical trial processes (e.g. operational manual, training plan, and templates, etc.) and ensure their implementation;
• Collaborate with stakeholders to maintain and improve clinical trial processes;
• Conduct compliance checks and analyze findings across assigned clinical trials;
• Act as a liaison for addressing procedural challenges and escalating concerns;
• Review and update written clinical trial processes as needed.
• Participate in developing, maintaining and improving the clinical trial processes as required;
• Review clinical trial specific plans and proposed clinical trial processes for compliance and practical issues and contribute to risk analysis.

• Higher level of education in a (bio)medical field;
• Indepth knowledge of legislation and regulations, clinical processes, industry practices and ICH-GCP and guidelines;
• A minimum of 3 years of experience as a Clinical Research Associate, Clinical Team Lead or Project Manager;
• Experience with working (on site) in international clinical trials is preferred;
• Experience in and passion for training and harmonising clinical trial processes;
• Proficiency in English and preferably also in Dutch;
• Creative /out of the box approach; multitasking, flexible, stress resistant and good overview skills.

Join a dynamic, collaborative, and supportive work culture where achievements are celebrated. Receive comprehensive training and guidance to excel in project compliance and enhance personal and professional skills. We are located in a beautiful monumental building, close to Slot Zeist and public transportation (e.g. busses and train station Driebergen-Zeist). We are flexible in working from home, requiring only an average of 1 day in the office per week.

Excited about this opportunity? Send your CV and motivation to vacancies@juliusclinical.com

Questions:

For further inquiries, please call Ellen Hunink, HR Business Partner (+31 6 21162980)