Clinical Research Associate (m/w/d) – Region: Stuttgart, Heilbronn, Heidelberg

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Position Summary

The Clinical Research Associate (CRA) is the primary point of contact at the site level for internal and external stakeholders, responsible for overseeing the quality, integrity and compliance of clinical trial sites in accordance with protocol, SOPs, ICH GCP, and applicable regulatory requirements.

Key Responsibilities

• Conduct site qualification, initiation, routine monitoring and close‑out visits across all trial phases, ensuring adherence to protocol, BMS SOPs and ICH GCP.
• Maintain the ethical and scientific integrity of clinical trials by verifying data within electronic systems and paper records, ensuring accessibility, completeness and accuracy.
• Monitor site adherence to ICH GCP and local regulations; provide training and support to site staff, and participate in sponsor and/or Health Authority audits and inspections.
• Cultivate and sustain effective relationships with cross‑functional teams and external partners, including vendors, clinical sites and key stakeholders.
• Motivate and influence sites to meet study objectives, including enrollment and retention goals.
• Communicate effectively, adapting to meet the needs of different stakeholders, using the most appropriate communication style and method.
• Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner.
• Assess potential investigators and sites to ensure sufficient resources and capabilities.
• Demonstrate understanding and proficiency of risk‑based monitoring approaches and risk mitigation strategies.
• Utilize strong analytical skills to evaluate site data and operational metrics, adjusting monitoring strategies based on data trends and site performance.
• Perform unblinded site monitor activities to protect the blind of the study.
• Review, reconcile and oversee study drug/IMP, and support label translation needs as applicable.
• Support regulatory compliance audits/inspections, developing and implementing site corrective and preventive actions.
• Assist in start‑up and submission related activities, including ICF review and document collection.
• Provide access to BMS and vendor systems for site personnel, ensuring systems are up‑to‑date for monitoring activities.
• Coordinate site activities related to database locks to meet local timelines.
• Perform site closure activities when all required protocol visits and follow‑up are completed.
• Degree/Certification/Licensure
• Bachelor’s degree required, preferably within life sciences or equivalent.
• Valid driver’s license (as locally required).

Qualifications & Experience

• 2–3 years of relevant clinical research experience as a CRA, able to work independently.
• Relevant prior Pharma/Biotech sponsor employment or experience as a clinical study coordinator preferred.
• Experience in the drug discovery/development process.
• Competencies
• Knowledge of clinical research processes, regulations and methodology.
• Understanding of clinical landscape with practical knowledge of various medical settings and records management.
• Working knowledge of ICH/GCP guidelines and applicable local laws.
• Analytical and critical‑thinking skills; ability to analyze complex data sets and develop solutions.
• Adaptability and growth mindset; open to new technologies and evolving methodologies.
• Organization and time‑management skills.
• Strong interpersonal skills to build, maintain and strengthen relationships under pressure.
• Excellent verbal and written communication skills in English and local language.
• Foundational disease understanding and awareness of standard of care.
• Proactive, autonomous work style with continuous learning.
• Ability to manage multiple protocols across therapeutic areas with travel as required.
• Proficiency in navigating multiple clinical systems (CTMS, e TMF, RBQM dashboards).
• Software That Must Be Used Independently And Without Assistance
• Clinical Trial Management Systems (CTMS).
• Electronic Data Capture Systems (e DC).
• Electronic Trial Master File (e TMF).
• RBM tools and platforms (e. g., Veeva, Medidata, Clue Points).

BMS is dedicated to ensuring people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support.

For accommodations, contact adastaffingsupport@bms. com.

Visit careers. bms. com/eeo-accessibility for our equal employment opportunity statement.

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Job Title: Clinical Research Associate (m/w/d) – Region: Stuttgart, Heilbronn, Heidelberg. Requisition Number: R1604118.

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