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Clinical Trials Manager - I
Ref No.: 18-00151
Location: Foster City, California
Position Type:Contract
Title: Clinical Trial Manager I
Location: Foster City, CA
Type: Contract:

Responsibilities:
  • Must meet all requirements for Senior Clinical Research Associate 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 projects priorities within functional area.
  • Under supervision, may design scientific communications within the company.
  • Travel is required.
Requirements:
  • 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.
  • 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.
  • Under general supervision, is able to examine functional issues from an organizational perspective.
  • 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.