Job Details

  • Title: Clinical Trials Manager
  • Code: RCI-GILD-06589
  • Location: Foster City California (CA) 94404
  • Posted Date: 07/11/2019
  • Duration: 12 Months
  • Status: Open
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  Job Description

  • Must meet all requirements for Senior CTMA position and have demonstrated proficiency in all relevant areas
  • Coordinating and supervising all aspects of a clinical study
  • Monitors clinical trial sites
  • Assists Clinical Program Manager in overall study management
  • Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports
  • Maintains study timelines
  • Contributes to development of study budget
  • Contributes to development of RFPs and participate in selection of CROs/vendors
  • Manage CROs/vendors
  • Coordinates review of data listings and preparation of interim/final clinical study reports
  • May contribute to development of abstracts, presentations, and manuscripts, Ensures effectiveness of site budget/contract process
  • May be asked to train CROs, vendors, investigators, and study coordinators on study requirements
  • Assists in determining the activities to support a project's priorities within functional area
  • Must be able to generally understand, interpret, and explain protocol requirements to others
  • Must be able to prioritize multiple tasks
  • May serve as a resource for others within the company for clinical trials management expertise
  • Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
  • Must have a general, functional expertise to support SOP development and implementation
  • Under general supervision, is able to examine functional issues from an organizational perspective
  • Under supervision, may design scientific communications within the company
  • CTM experience (at least 2 y experience, already performing at the CTM level) – we need experienced people that can hit the ground running immediately
  • Biotech/ pharma experience required (eventually only CRO experience will be considered if it was in a full-service provider capacity)
  • Global phase 3 experience required
  • Inflammation experience preferable
  • Excellent teamwork, communication, decision-making and organizational skills are required
  • Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
  • Travel is required