Project Compliance Manager

At Julius Clinical, we thrive on the diversity of our work. From crafting monitoring manuals to conducting Project Compliance Checks, each day presents new challenges and opportunities. As a Project Compliance Manager, you’ll be at the forefront of shaping and ensuring compliance across various (international) clinical trials in different therapeutic areas and phases.

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 demanding, challenging circumstances.

• Develop project specific clinical trial processes (e.g. monitoring manual, training plan, Project File Indexes  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 issues 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 project 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;
• Basic 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;

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).