Job description
As a Clinical Study Manager, you will be responsible for the planning, coordination, execution, and oversight of clinical studies for Class I and Class II medical devices, ensuring compliance with applicable regulations and quality standards.
Your responsibilities include:
Lead the operational management of clinical studies from study start-up through close-out.
Develop, review, and maintain clinical study documentation, including clinical protocols, informed consent forms, study plans, monitoring plans, and clinical reports.
Ensure studies are conducted in compliance with ISO 14155, ISO 13485, MDR, GCP, and internal quality procedures.
Coordinate cross-functional clinical teams including Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Data Management, Biostatistics, Regulatory Affairs, Quality Assurance, Medical Affairs, and R&D.
Manage study timelines, milestones, budgets, risks, and deliverables.
Oversee site selection, initiation, monitoring activities, and study close-out in collaboration with CRAs.
Support investigators and study sites by providing guidance on protocol requirements and regulatory compliance.
Review clinical data for quality, completeness, and consistency, resolving study issues and protocol deviations where necessary.
Contribute to continuous improvement of clinical processes and study execution.
Prepare documentation for regulatory submissions and audits.
Ensure inspection readiness and support internal and external audits.
Required Qualifications
Master's degree or PhD in Life Sciences, Biomedical Sciences, Medicine, Pharmacy, Biomedical Engineering, or another scientific discipline.
Minimum 3 years of experience as a Clinical Study Manager within the medical device industry.
Experience managing clinical studies involving Class I and/or Class II Medical Devices.
Strong knowledge of:
ISO 14155
ISO 13485
Good Clinical Practice (ICH-GCP)
EU Medical Device Regulation (MDR)
Experience with clinical protocol writing and development of clinical study documentation.
Experience working within multidisciplinary clinical teams involving CRA, CRC, Data Management, Regulatory Affairs, Quality, and R&D.
Excellent project management and stakeholder management skills.
Strong communication skills in English and Dutch.
Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!
