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About the role
Key responsibilities & impact- Supports Global Study Managers (GSMs) and other Study Operations Managers (SOMs) to deliver study management by leading specific parts of projects
- Oversees the preferred Contract Research Organization (pCRO) at country level and manages country level plans
- Liaises with Site Care Partners (SCP) and regulatory colleagues to agree on submission strategy to Health Authorities (HAs)
- Collaborates to identify and manage deviations and risks in study startup and execution
- Ensures compliance to relevant global and local, internal and external requirements, and regulations
Requirements
What you’ll need- Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 5 years of relevant operational clinical trial experience required
- Master’s of Science or Master’s of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required
- Comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management team
- Demonstrated clinical research experience and/or study management/startup project manager experience
- Must be fluent in English.
Benefits
Comp & perks- Health insurance
- Flexible working arrangements
- Professional development opportunities
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 experiencestudy managementproject managementregulatory compliancerisk managementsubmission strategyoperational experiencedeviation managementstudy startup
Soft Skills
collaborationcommunicationleadershiporganizational skills
Certifications
Bachelor’s degreeMaster’s degree