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Senior Clinical Research Associate
BeOne MedicinesCRA executing clinical monitoring activities and collaborating with clinical study teams for oncology trials in France. Mentoring junior staff and ensuring quality standards are maintained.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical monitoring activities, ensuring compliance with ICH guidelines and GCP while effectively managing site performance and mentoring junior staff. Proficient in conducting various monitoring visits and maintaining inspection readiness across clinical trials.
Highest-signal resume keywords
Clinical Monitoring ExperienceGCP ComplianceICH Guidelines KnowledgeOncology Trial ExperienceBilingual in English and French
ATS Keywords
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Hard Skills
Clinical Trial MonitoringRegulatory Submissions TrackingSite Performance ManagementPre-Study and Closeout VisitsProblem-Solving Skills
Soft Skills
Organizational SkillsEffective Relationship BuildingMentoring Junior Staff
Industry Keywords
Oncology TrialsOnco-Hematology TrialsInspection ReadinessClinical Research Regulatory Requirements
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Execute clinical monitoring activities at clinical trial sites
- Monitor clinical trials in accordance with ICH guidelines and GCP
- Collaborate closely with Country and Regional Clinical Study Teams
- Conduct pre-study, initiation, routine monitoring and closeout visits
- Manage site performance by tracking regulatory submissions and recruitment
- Ensure inspection readiness of the study and sites
- Mentor junior staff and act as escalation point for site-related issues
Requirements
What you’ll need- BS in a scientific or healthcare discipline preferred
- At least 3 - 5 years of monitoring experience
- Experience in oncology/onco-hematology global trials preferred
- Advanced knowledge of applicable clinical research regulatory requirements (GCP, ICH guidelines)
- Excellent organizational and problem-solving skills
- Ability to establish and maintain effective working relationships
- Must be fluent in English and French.
Benefits
Comp & perks- Health insurance
- Professional development opportunities
- Flexible working hours
- Paid time off
- Remote work options