Global Clinical Trial Leader (Hybrid) at Dawar Consulting, Inc.

South San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

03 Sep, 26

Salary

90.0

Posted On

05 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Management, CRO Management, GCP, ICH Guidelines, Phase I/II Trials, Vendor Management, Risk Management, Study Planning, Protocol Feasibility, TMF, CTMS, Drug Supply Forecasting, Budget Planning, Operational Leadership, Regulatory Compliance, Site Selection

Industry

IT Services and IT Consulting

Description

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 hr@dawarconsulting.com/akansha@dawarconsulting.com

Responsibilities

Lead the operational execution and delivery of global Phase I and II clinical trials within Research and Early Development. Manage cross-functional teams, CROs, and vendors to ensure compliance with GCP/ICH and regulatory requirements.