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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.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in overseeing clinical trial site quality, integrity, and compliance with ICH GCP and local regulations. Proficient in risk assessment and relationship management with stakeholders to ensure successful trial execution.
Highest-signal resume keywords
Clinical Research ExperienceICH/GCP Guidelines KnowledgeSite MonitoringRisk AssessmentClinical Systems Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial OversightSite QualificationSite InitiationRoutine MonitoringClose-Out VisitsCompliance ManagementReport PreparationRisk Mitigation
Soft Skills
Relationship ManagementEffective CommunicationProblem Solving
Tools & Technologies
CTMSETMFRBQM Dashboards
Industry Keywords
PharmaBiotechClinical Study CoordinatorStandard Operating ProceduresInternational Council for Harmonization
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