Our client, a worldleader in biotechnology and life sciences, is looking for a "GlobalClinical Trial Leader" based out of South San Francisco, CA(Hybrid).
Job Duration: LongTerm Contract (Possibility Of Extension)
Pay Rate : $90/hr on W2
Company Benefits: Medical, Dental,Vision, Paid Sick leave, 401K
Support the executionand delivery of global Phase I and II clinical trials within Research and EarlyDevelopment (RED). Partner with cross-functional teams, vendors, andstakeholders to ensure successful study execution, risk management, operationalexcellence, and compliance with GCP/ICH and regulatory requirements.
Key Responsibilities:
- Provide operational leadership and guidance to global cross-functional ProtocolExecution 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.
- ManageCROs 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.
Qualifications:
- Bachelor’s 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.
Preferred Experience:
·Earlydevelopment clinical trial experience.
·Globalstudy execution and operational strategy experience.
·Experiencemanaging complex, multi-country clinical studies.
Travel: Some travel may be required.
If interested, pleasesend us your updated resume at
hr@dawarconsulting.com
/
akansha@dawarconsulting.com