Boston Scientific Clinical Research Associate French 

Belgium, Flemish Brabant 

34645552

Belgium-Diegem; Netherlands-Kerkrade; Netherlands-Kerkrade

EMEA hub (Belgium, Netherlands)

Key Responsibilities:

• Coordinate and Lead:Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, drive site regulatory submissions and essential document collection for clinical research sites throughout start up,enrollment, follow-up, and closure of clinical trial activities.
• Document Management:Handle multiple sets of essential regulatory documents across several studies.
• Collaborate:Partner with clinical sites to negotiate and customize Informed Consent Forms (ICF). Collaborate cross functionally to achieve business objectives.
• Relationship Building:Develop and foster relationships with internal customers and clinical research sites to become a subject matter expert in site start-up regulatory processes.
• Problem Solving:Assist clinical research sites with application submission processes and approval tracking to meet target IRB/EC timelines. Problem-solve site start-up challenges to mitigate impact on service level agreements and study goals.
• Prepare and Track:Prepare, complete, and track required regulatory, ICF, and legal documentation.
• Quality Assurance:Document site and investigator readiness for participation across multiple studies.
• Support:Assist with internal quality audits and regulatory inspections.
• Maintain:Keep study-specific startup and close-out trackers updated.
• Update:Maintain site-specific metrics in Clinical Trial Management Systems and electronic Trial Master File (eTMF).
• Communicate:Provide updates to leadership on site start-up activities, investigator readiness, regulatory submission, and approval status.
• Compliance:Ensure adherence to regulatory requirements (ICH/GCP, MDR, GDPR) and internal SOPs/WI, policies, and procedures.

Qualifications:

• Educational Background:Degree in a relevant scientific or healthcare subject.
• Experience:2/5 years of experience in study submissions to Ethics Committees in France.
• Language Skills:Fluency in French and English; additional languages are beneficial.
• Communication:Strong communication skills and ability to interact with clinical research site personnel.
• Team Player:Ability to work independently and in a team environment.
• Problem-Solving:Strong problem-solving skills and learning agility.

Preferred Qualifications:

• Experience:Previous experience as a Research Coordinator or Clinical Research Associate/Study Start-up Specialist. Experience in study submissions to Ethics Committees in Belgium (French speaking) is valued.
• Technical Skills:Familiarity with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems/eTMF.

What We Offer:

• Innovative Environment:Work in a groundbreaking multinational company with attractive benefits.
• Growth Opportunities:Access to upskilling and mentoring programs.
• Purposeful Mission:Be part of a company with a purposeful mission.
• Stability:Enjoy a permanent position with a hybrid work model.
• Work-Life Balance:Benefit from a hybrid work environment that supports work-life balance.