Global Clinical Trial Leader (Hybrid)

Reposted 10 Days Ago
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South San Francisco, CA, USA
In-Office
90-90 Hourly
Senior level
HR Tech • Information Technology • Professional Services • Consulting
The Role
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.
Summary Generated by Built In

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]

 



Skills Required

  • Bachelor's degree
  • Degree in a scientific or healthcare-related discipline
  • 8+ years of clinical study management experience in 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
  • Early development clinical trial experience
  • Global study execution and operational strategy experience
  • Experience managing complex, multi-country clinical studies
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The Company
Year Founded: 2009

What We Do

Dawar Consulting Inc. is a professional services and staff augmentation firm specializing in IT consulting, workforce solutions, and HCM/HRIS services. They provide technology and business consulting, project delivery, and IT support to help clients achieve their strategic goals. With expertise across IT, Engineering, and Finance, they deliver best-in-class workforce solutions and innovative strategies to drive operational efficiency and business success.

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