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Early Development Clinical Trial Manager

Thousand Oaks, CA
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to this company, its operations, or its staff.”

Top 3 Must Have Skill Sets:        
  • Must have directly managed a global study/clinical trials in depth
  • Must have CRO/Vendor management experience
  • Must be willing to potentially support different time zones

Day to Day Responsibilities:            
  • Lead the Clinical Study Team to drive effective decision making
  • Develop early phase clinical operation strategy and contributes to the strategic scenario planning in clinical development plan
  • Oversee the quality and scientific integrity of clinical operations for early development studies at a global level
  • Lead study level planning of the overall clinical operation, execute day-to-day operations of clinical trial at a global level and resolve issues escalated by the local study team
  • Collaborate with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
  • Ensure implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
  • Manage vendors to the required standards
  • Contribute to the development and/or review of study-related documentation, including but not limited to monitoring plan, risk management tool, eCRF, manuals, training materials,
  • safety and regulatory documents, and clinical study report.

Summary 
The primary point of contact to lead, manage and co-ordinate the conduct of Phase 1/1b clinical trials from study design to close out at a global level in accordance with ICH-GCP.
Assignment Duration: 6-12 months
Location needed (or remote): Remote

"This posting is for Contingent Worker, not an FTE"
 

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