Clinical Study Manager
Netherlands, North Brabant, Eindhoven
Fulltime: 40 hrs a week / € 5200 - 6200 per month
Experience: 4-6 Years
Medical devices
Introduction
As a Clinical Study Manager, you lead clinical studies that directly contribute to the development of innovative healthcare and consumer health technologies used by people worldwide.
What are you going to do
- Lead the execution and management of clinical studies in compliance with applicable regulations and standards such as ISO, ICH-GCP and FDA guidelines.
- Coordinate study sites, investigators and internal stakeholders while ensuring adherence to protocols through site assessments, monitoring visits, training and close-out activities.
- Oversee study documentation, data review and verification to ensure accuracy, completeness and regulatory compliance throughout the clinical research lifecycle.
- Monitor study progress, analyze trends and deviations, resolve issues and drive improvements in study procedures to ensure timelines, budgets and study objectives are achieved.
Essential skills and knowledge
- A minimum bachelor's or master's degree in Life Sciences, Biomedical Sciences, Clinical Research or a related field.
- At least 5 years of experience in clinical research within the medical device, pharmaceutical or another regulated industry.
- Strong knowledge of clinical research regulations and ICH-GCP guidelines.
- Experience with clinical trial systems such as Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS) and Electronic Trial Master File (eTMF).
- Candidate needs to be based in the Netherlands.
What we offer
- A gross monthly salary depending on experience up untill € 6.200,- (excluding 8% holiday allowance).
- Travel allowance per km, or OV Card.
- 26 vacation days, with the option to extend.
- Flexibility and hybrid working possibilities where applicable.
- Extensive training and career development opportunities through the Brunel Academy.
- A solid pension scheme and collective health insurance.
- Discounts on gyms, cultural activities and vitality programs.
About Brunel
Brunel Engineering connects highly skilled professionals with challenging projects across multiple industries. You will work in an open and professional environment where initiative and personal development are encouraged. As a Brunel consultant, you benefit from the security of a permanent contract, excellent employment conditions and continuous opportunities to expand your expertise. This is your opportunity to develop your career while working on impactful projects in a dynamic and results-driven environment.