Job Details

  • Title: Clinical Trial Manager
  • Code: RCI-07510
  • Location: Foster City California (CA) 94404
  • Posted Date: 12/02/2019
  • Duration: 12 Months
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  Job Description

Must meet all requirements for Clinical Trials Manager and have demonstrated proficiency in all relevant areas.

  • In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines
  • Coaches members of a work team and ensures adherence to established guidelines
  • Provide input to program budget and timelines to ensure successful management of all aspects of international clinical trials
  • Anticipates obstacles and client difficulties and implements solutions to achieve project goals
  • Assists CPM in revising project timelines/budgets as necessary
  • Works with management on departmental issues, providing input to clinical operations strategies and work plans
  • Communicates with functional peers regarding project status and issues and ensure project team goals are met
  • Contributes to development of abstracts, presentations and manuscripts
  • Participate in the recruiting and hiring process for CPA/CRAs and support their professional development
  • Participate in training of CPAs and CRAs
  • Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements
  • Excellent interpersonal skills and demonstrated ability to lead is required
  • Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction
  • Strong communication and influence skills and ability to create a clear sense of direction is necessary
  • Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction
  • Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials
Qualifications:
  • Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required
  • Functional expertise to initiate, author, or contribute to SOP development, implementation, and training
  • Experience in developing RFPs and selection and management of CROs/vendors
  • Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, NDA, etc.) with little supervision
  • Ability to examine functional issues from a broader organizational perspective
  • Travel is required