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Project Manager Clinical Research Location: Mission Viego, CA

Posted By
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2018-11-13 22:35:20
Job Type: Full Time only

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PositionOverview

  • Manages company-sponsored and investigator-sponsored clinical studies in line with institutional, GCP, regulatory, and compliance requirements
  • Collaborates with study PIs, coordinating centers, CROs, and/or sponsoring institutions to develop protocols, establish budgets, construct databases, select sites, set enrollment targets, and implement enrollment and mitigation plans
  • Works with legal team to facilitate preparation of clinical trial agreements, physician consulting agreements, and other related contracts
  • Partners with study site coordinators to prepare IRB submissions and address IRB questions
  • Prepares/assists in the preparation of study documentation including protocol amendments, Case Report Forms, Informed Consent Forms, and monitoring plans
  • Facilitates/supports training of and communication with study sites/subsites via regular email/phone contact, study newsletters, and in-person investigator and coordinator meetings
  • Reports, tracks, and interprets study data, enrollment trends, and other metrics
  • Ensures appropriate safety/adverse events reporting
  • Tracks and manages study budgets and expenditures
  • Provides regular study status reports to management and internal business partners
  • Reviews publication drafts and fields physician requests for publication support as needed
  • Leads pilot data collection efforts as needed
  • Attends study investigator/coordinator meetings, offsite study meetings, and other professional conferences as needed to support study startup and enrollment
  • Directs Clinical Research Associates, Clinical Research Coordinators, and administrative personnel as needed to support the above activities
  • Performs other clinical research-related duties as assigned

Desired Qualifications:

····IDEand/or global clinical research experience a plus


Key Skills: