Senior Clinical Research Associate

BD; Erembodegem; Sur place; EUR 60 000 - 92 000; Plein temps

Résumé du poste

BD Peripheral Intervention is recruiting a Senior Clinical Research Associate to lead site management for global medical device studies. You will act as the primary site contact, drive performance, ensure regulatory compliance, and support data quality and timely study delivery.

This role suits a clinical research professional who thrives in a dynamic environment, collaborates with cross-functional teams, and has extensive experience in site monitoring and regulatory guidelines.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Minimum of 5 years of clinical research experience in medical devices, pharma, or biotech.
• Minimum of 4 years in site management, monitoring, or clinical project management.
• Strong knowledge of ICH-GCP, ISO 14155, and global regulations.
• Familiarity with eTMF, CTMS, and CDMS platforms.
• Willingness to travel up to 60%+ during peak periods.
• Experience in peripheral vascular disease, kidney disease, and/or oncology studies.
• Previous medical device clinical research experience.
• Proficiency with Veeva Vault CTMS, CDMS, and eTMF.
• Professional certification (ACRP, SOCRA, or equivalent).
• Fluent in Dutch, English and German.

Responsabilités

• Lead site management from qualification to close-out.
• Build relationships with investigators and site staff.
• Conduct on-site and remote monitoring per protocols and GCP/ISO 14155.
• Drive site activation, enrollment, retention, and performance.
• Identify risks and implement mitigation strategies.
• Ensure data quality and protocol compliance.
• Review and contribute to study documentation.
• Support audits and inspections and resolve findings.
• Collaborate with Clinical Project Managers and cross-functional teams.
• Contribute to process improvements and monitoring tools.

Connaissances

Dutch (Fluent)

English (Fluent)

German (Fluent)

Formation

Bachelor's degree in Life Sciences

Outils

Veeva Vault CTMS

CDMS

eTMF

Description du poste

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

About the role

BD Peripheral Intervention is seeking an experienced and proactive Senior Clinical Research Associate (Sr. CRA) to support the successful execution of global medical device clinical studies. In this role, you will serve as the primary point of contact for assigned investigational sites, driving site performance, ensuring regulatory compliance, maintaining data quality, and contributing to the timely delivery of study objectives.

This is an exciting opportunity for a clinical research professional who thrives in a dynamic environment and enjoys collaborating with cross‑functional teams to bring innovative medical technologies to patients.

Main Responsibilities Will Include

• Lead site management activities from site qualification and initiation through study close‑out.
• Build and maintain strong relationships with investigators, study coordinators, and site personnel.
• Conduct on‑site and remote monitoring visits in accordance with study protocols, Good Clinical Practice (GCP), ISO 14155, and applicable local and international regulations.
• Drive site activation, patient enrollment, retention, and overall site performance.
• Identify potential risks and operational challenges and implement effective mitigation strategies.
• Ensure the accuracy, completeness, and quality of clinical data while maintaining protocol compliance.
• Review and contribute to the development of essential clinical study documentation.
• Support internal and external audits and inspections and ensure timely resolution of findings related to site management and monitoring activities.
• Partner closely with Clinical Project Managers and cross‑functional stakeholders to provide site‑level expertise and recommendations.
• Contribute to process improvements, best practice sharing, and the development of clinical monitoring tools and resources.

About You

• Bachelor's degree in Life Sciences or a related field, or an equivalent combination of education and experience.
• Minimum of 5 years of experience in clinical research within the medical device, pharmaceutical, or biotechnology industry.
• Minimum of 4 years of experience in site management, monitoring, and/or clinical project management.
• Strong knowledge of domestic and international clinical research regulations, ICH‑GCP, ISO 14155, and industry best practices.
• Familiarity with clinical study systems, including eTMF, CTMS, and CDMS platforms.
• Willingness and ability to travel up to 60% or more during peak study periods.
• Experience supporting clinical studies in peripheral vascular disease, end‑stage kidney disease and/or oncology.
• Previous experience in medical device clinical research.
• Proficiency with Veeva Vault CTMS, CDMS and eTMF.
• Professional certification through organizations such as ACRP, SOCRA or equivalent.
• Fluent in Dutch , English and German.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply and build a stronger culture. Join us and enjoy a culture where face‑to‑face collaboration supports your learning, your progress and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

Primary Work Location

BEL Erembodegem - Dorp 86

Additional Locations

DEU Karlsruhe, NLD Amsterdam - Hoogoorddreef

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance‑based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You".

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

€60.300,00 - €91.950,00 EUR Annual