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About the role
Key responsibilities & impact- Oversee all aspects of clinical trial execution, including start-up, monitoring, and close-out activities for all ARTBIO programs.
- Lead the clinical operations team and ensure that the company achieves study goals and objectives.
- Collaborate closely with cross-functional teams to drive the successful execution of clinical study plans.
- Manage CRO(s) performance to ensure adherence to the scope of work within timelines and budget.
- Build out an in-house CRA team for Phase 1 study monitoring.
- Proactively assess potential risks to clinical studies and propose mitigation plans.
Requirements
What you’ll need- Bachelor’s, Master's, or higher qualification in life sciences or nursing.
- Minimum of 7 years of experience in clinical development, including at least 5 years in clinical operations of Phase 1 or 2 oncology clinical studies.
- At least 2 of the years in a clinical trial or project management leadership role.
- Cross-functional understanding and technical knowledge of drug development processes and clinical trial methodology.
- Thorough knowledge and understanding of Good Clinical Practices, ICH Guidelines, and applicable international regulations and guidelines.
- Strong project management/organizational skills.
- Excellent technical experience with MS applications (e.g., MS Project, Word, Excel).
- Experience with study tools, including CTMS, eTMF, Medidata RAVE, and other EDC systems.
Benefits
Comp & perks- EEO Statement: ARTBIO is an equal opportunity workplace.
- Remote flexibility with up to 25% travel within the United States.
- 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 executionclinical operationsproject managementrisk assessmentclinical trial methodologyGood Clinical PracticesICH Guidelinesdrug development processesPhase 1 oncology clinical studiesPhase 2 oncology clinical studies
Soft Skills
leadershipcollaborationorganizational skillscommunicationteam management
Certifications
Bachelor’s degreeMaster's degreehigher qualification in life scienceshigher qualification in nursing
