Biology, Biotech and Pharmaceutical, Budget Management, Budgeting, Clinical Best Practices, Clinical Research, Clinical Trial, Contract Research Organization (CRO), Cross-Functional, Drug Development, GCP (Good Clinical Practices), Healthcare, Leadership, Mentoring, Operational Strategy, Operations Planning, Phase I Clinical Trials, Phase II Clinical Trials, Process Improvement, Regulations, Regulatory Requirements, Risk Analysis, Risk Management, Startup, Strategic Planning, Time Management, Vendor/Supplier Evaluation, Vendor/Supplier Management
South San Francisco, California
Our client, a world
leader in biotechnology and life sciences, is looking for a "<\/b><\/span>Global
Clinical Trial Leader"<\/span><\/b> based out of South San Francisco, CA(Hybrid).<\/b><\/span>
<\/p>
<\/span><\/b>
<\/p>
Job Duration: Long
Term Contract (Possibility Of Extension)<\/span><\/b>
<\/p>
Pay Rate : $90/hr on W2<\/span><\/b>
<\/p>
<\/span><\/b>
<\/p>
Company Benefits:<\/span><\/b> Medical, Dental,
Vision, Paid Sick leave, 401K<\/span>
<\/p>
<\/span>
<\/p>
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.<\/span>
<\/p>
<\/span><\/b>
<\/p>
Key Responsibilities:<\/span><\/b>
<\/p>- Provide
operational leadership and guidance to global cross -functional Protocol
Execution Teams (PETs) across study start -up, conduct, and close -out
activities.<\/span>
<\/li> - Drive
delivery of key trial deliverables including vendor specifications, drug
supply forecasting, monitoring plans, TMF, and CTMS documentation.<\/span>
<\/li> - Collaborate
with cross -functional stakeholders on study planning, protocol
feasibility, site selection, and investigator meetings.<\/span>
<\/li> - Manage
CROs and vendors to ensure performance aligns with contracted scope,
timelines, quality, and budget expectations.<\/span>
<\/li> - Contribute
to study budget planning and oversee assigned vendor budgets.<\/span>
<\/li> - Identify
operational risks, develop mitigation strategies, and proactively manage
study timelines and issues.<\/span>
<\/li> - Support
process improvement initiatives and contribute to clinical operations best
practices.<\/span>
<\/li> - Mentor
junior team members and serve as a subject matter expert for designated
initiatives.<\/span>
<\/li><\/ul> <\/span><\/b>
<\/p>
Qualifications:<\/span><\/b>
<\/p>- Bachelor’s
degree required; scientific or healthcare -related discipline preferred.<\/span>
<\/li> - 8+
years of clinical study management experience within the pharmaceutical,
biotech, or CRO industry.<\/span>
<\/li> - Experience
supporting global Phase I and/or Phase II clinical trials.<\/span>
<\/li> - Strong
vendor and CRO management experience.<\/span>
<\/li> - Working
knowledge of GCP, ICH guidelines, international regulations, and the drug
development process.<\/span>
<\/li><\/ul> <\/span>
<\/p>
Preferred Experience:<\/span><\/b>
<\/p>
· <\/span><\/span><\/span>Early
development clinical trial experience.<\/span>
<\/p>
· <\/span><\/span><\/span>Global
study execution and operational strategy experience.<\/span>
<\/p>
· <\/span><\/span><\/span>Experience
managing complex, multi -country clinical studies.<\/span>
<\/p>
<\/span>
<\/p>
Travel:<\/span><\/b>
Some travel may be required.<\/span><\/p>
<\/span>
<\/p>
<\/span>
<\/p>
If interested, please
send us your updated resume at<\/span>
<\/p>
hr@dawarconsulting.com
akansha@dawarconsulting.com
<\/span>
<\/p>
<\/div><\/span>