Our client, a world leader in biotechnology and life sciences, is looking for a聽"Global Clinical Trial Leader"聽based out of聽South San Francisco, CA(Hybrid).
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Job Duration:聽Long Term Contract聽(Possibility Of Extension)
Pay Rate : $90/hr on W2
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Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K
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Support the execution and delivery of global Phase I and II clinical trials within Research and Early Development (RED). Partner with cross-functional teams, vendors, and stakeholders to ensure successful study execution, risk management, operational excellence, and compliance with GCP/ICH and regulatory requirements.
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Key Responsibilities:
- Provide operational leadership and guidance to global cross-functional Protocol Execution Teams (PETs) across study start-up, conduct, and close-out activities.
- Drive delivery of key trial deliverables including vendor specifications, drug supply forecasting, monitoring plans, TMF, and CTMS documentation.
- Collaborate with cross-functional stakeholders on study planning, protocol feasibility, site selection, and investigator meetings.
- Manage CROs and vendors to ensure performance aligns with contracted scope, timelines, quality, and budget expectations.
- Contribute to study budget planning and oversee assigned vendor budgets.
- Identify operational risks, develop mitigation strategies, and proactively manage study timelines and issues.
- Support process improvement initiatives and contribute to clinical operations best practices.
- Mentor junior team members and serve as a subject matter expert for designated initiatives.
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Qualifications:
- Bachelor鈥檚 degree required; scientific or healthcare-related discipline preferred.
- 8+ years of clinical study management experience within the pharmaceutical, biotech, or CRO industry.
- Experience supporting global Phase I and/or Phase II clinical trials.
- Strong vendor and CRO management experience.
- Working knowledge of GCP, ICH guidelines, international regulations, and the drug development process.
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Preferred Experience:
路聽聽聽聽聽聽 Early development clinical trial experience.
路聽聽聽聽聽聽 Global study execution and operational strategy experience.
路聽聽聽聽聽聽 Experience managing complex, multi-country clinical studies.
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Travel:
Some travel may be required.
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If interested, please send us your updated resume at
hr@dawarconsulting.com/akansha@dawarconsulting.com
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