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Clinical Research Associate – m/w/d
Bristol Myers SquibbClinical Research Associate overseeing compliance and integrity of clinical trials in Germany. Conducting site visits and maintaining relationships with stakeholders in the clinical research process.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- primary point of contact at the site level for both internal and external stakeholders
- responsible for overseeing the quality, integrity and compliance of clinical trial sites in accordance with the protocol, Standard Operating Procedures (SOPs), International Council for Harmonization (ICH) Guideline for Good Clinical Practice (GCP), and applicable regulatory requirements
- Conduct site qualification, initiation, routine monitoring and close-out visits across all trial phases
- Monitor site adherence to ICH GCP and local regulations
- Cultivate and sustain effective relationships with internal cross-functional teams and external partners
- Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
- Identify, assess, and prioritize risks at the site and study level and support sites in mitigating issues
Requirements
What you’ll need- 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, able to work independently
- demonstrated proficiency in all aspects of the role
- Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred
- Working knowledge of ICH/GCP Guidelines and applicable local laws and regulations
- Proficient in navigating and utilizing multiple clinical systems (e.g., CTMS, eTMF, RBQM dashboards)
Benefits
Comp & perks- wide variety of competitive benefits, services and programs
- resources to pursue goals
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Clinical Trial OversightSite QualificationSite InitiationRoutine MonitoringClose-Out VisitsCompliance ManagementReport PreparationRisk Mitigation
Soft Skills
Relationship ManagementEffective CommunicationProblem Solving