Global Clinical Trial Leader (Hybrid)

Dawar Consulting•South San Francisco, CA

1d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

Early development clinical trial experience.
Global study execution and operational strategy experience.
Experience managing complex, multi-country clinical studies.

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.