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

Position Summary The Clinical Research Associate (CRA) is the primary point of contact at the site level for both internal and external stakeholders. The CRA oversees 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 in accordance with the Site Monitoring Plan. Verify data within electronic systems and paper records (as applicable) to ensure accessibility, completeness, and accuracy of data submitted by study sites. Monitor site adherence to ICH GCP and local regulations, including compliance with ALCOA principles. Provide training and support to site staff to uphold standards and ensure patient safety. Participate in sponsor and/or Health Authority audits and inspections as applicable. Maintain effective relationships with internal cross‑functional teams and external stakeholders, including vendors, clinical sites, and key stakeholders. Represent the organization for clinical trials at the site level and motivate sites to meet study objectives, including enrollment and retention goals. Prepare and submit written monitoring and administrative reports in a timely, accurate, concise, professional, and objective manner. Assess potential investigators and their sites to ensure sufficient resources and capabilities for clinical trials. Identify new potential investigators and/or sites during the site feasibility and selection process. Implement centralized, remote, and risk‑based monitoring approaches, identify, assess, and prioritize risks at site and study levels, and support sites in mitigation. Evaluate site data and operational metrics, adjusting monitoring strategies based on data trends and site performance. When required, perform unblinded site monitor activities to protect the study blind. Review, reconcile, and oversee study drug/IMP, supporting label translation needs as applicable. Support regulatory compliance audits and inspections, including development and implementation of site corrective and preventive actions. Coordinate site activities related to database locks and ensure timelines are met locally. Perform timely site closure activities when all required protocol visits and follow‑up are completed. Qualifications & Experience Bachelor’s degree required, preferably within life sciences or equivalent. Valid driver’s license (as locally required). 2–3 years of relevant clinical research experience as a CRA, able to work independently and demonstrate proficiency in all aspects of the role. Prior Pharma/Biotech sponsor employment or experience as a clinical study coordinator preferred. Experience in the drug discovery/development process. Competencies Knowledge and understanding of clinical research processes, regulations, and methodology. Practical knowledge of a variety of medical settings and medical records management. Working knowledge of ICH/GCP guidelines and applicable local laws and regulations. Analytical and critical thinking skills; ability to analyze diverse data sets and identify issues, trends, and outliers. Adaptability and a growth mindset; quickly learning and applying new technologies and methodologies. Excellent organization, time‑management, and relationship‑building skills. Strong verbal and written communication skills in English and the local language. Foundational understanding of disease areas related to the protocol’s therapeutic area. Proficiency in multiple clinical systems (CTMS, eTMF, RBQM dashboards, etc.) and independent use of CTMS, eDC, eTMF, and RBM tools. Equal Employment Opportunity statement: Visit careers.bms.com/eeo-accessibility for our complete EEO statement. #J-18808-Ljbffr Bristol-Myers Squibb