Lead global Phase I/II clinical trial execution within early development. Oversee cross-functional Protocol Execution Teams, manage CROs/vendors, drive study start-up through close-out, ensure compliance with GCP/ICH, control budgets, mitigate operational risks, and mentor junior staff.
Our client, a world
leader in biotechnology and life sciences, is looking for a "Global
Clinical Trial Leader" based out of South San Francisco, CA(Hybrid).
Job Duration: Long
Term Contract (Possibility Of Extension)
Pay Rate : $90/hr on W2
Company Benefits: Medical, Dental,
Vision, Paid Sick leave, 401K
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.
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.
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:
· Early
development clinical trial experience.
· Global
study execution and operational strategy experience.
· Experience
managing complex, multi-country clinical studies.
Travel:
Some travel may be required.
If interested, please
send us your updated resume at
[email protected]/[email protected]
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