Supports global Phase I/II clinical trial execution from start-up through close-out. Provides operational leadership to cross-functional teams, CROs, vendors, and investigators; manages feasibility, timelines, risks, budgets, documentation, monitoring plans, drug supply forecasting, and regulatory compliance. Contributes to process improvement, organizational change, and patient- and site-centric trial delivery while serving as a subject matter expert and mentor.
Our client, a world
leader in life sciences and biotechnology, is looking for a “Global
Clinical Trial Leader” based in SSF, CA (Hybrid).
Job Duration: Long
Term Contract (Possibility Of Extension)
Pay Rate : $103/hr on
W2
Company Benefits: Medical, Paid Sick
leave, 401K
The Global Clinical
Trial Leader (CTL) will support the execution and delivery of complex
early-phase global clinical trials (Phase I/II) for innovative new molecular
entities. Working under the Sr. CTL, this role provides operational leadership
across study start-up, conduct, and close-out while coordinating
cross-functional teams, CROs, and vendors.
Key Responsibilities:
- Provide
operational leadership to global Protocol Execution Teams (PETs)
throughout the trial lifecycle.
- Support
study planning, site/country feasibility, protocol execution, timelines,
and risk mitigation.
- Manage
CROs/vendors, including performance, scope, deliverables, and assigned
budgets.
- Drive
key study documentation, including TMF, CTMS, monitoring plans, drug
supply forecasting, and vendor specifications.
- Collaborate
with cross-functional teams and investigators to ensure successful trial
execution.
- Identify
operational risks, bottlenecks, and issues and develop practical
solutions.
- Contribute
to process improvements and operational best practices across gRED/Roche.
- Support
a patient- and site-centric approach to clinical trial execution.
- Act
as an SME, mentor colleagues, and contribute to organizational change
initiatives.
Required
Qualifications:
- Bachelor’s
degree or equivalent; scientific/healthcare discipline preferred.
- 8+
years of clinical study management experience preferred.
- Hands-on
experience managing delegated aspects of global Phase I/II clinical
trials.
- Strong
CRO/vendor management experience.
- Knowledge
of GCP/ICH, international regulatory requirements, and end-to-end drug
development.
If interested, please
send us your updated resume at
[email protected]/[email protected]
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