Sr. Clinical Project Manager

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Sr. Clinical Project Manager
Brisbane, CA
Permanent Position

The CPM will provide programmatic support that may include but not be limited to the following activity:
  • Developing clinical plans, timelines and budgets
  • Managing all operational aspects of trial implementation, including ensuring compliance with GCP, SOPs, and Regulatory requirements
  • Developing Clinical Protocols and associated documentation, such as Informed Consent Forms (ICFs), eCRFs, Data Capture Tools (Patient Reported Outcomes), and technical study manuals
  • Managing regulatory and core clinical documentation (Trial Master File)
  • Overseeing Quality Management as it pertains to a given trial or program
  • Managing clinical strategic outsourcing, including vendor selection and oversight, and development of the vendor management plan
  • Managing Central Laboratories and working with the Translational Research team to support the Biomarker Plan.
  • Bachelor's degree (BS/BA/BScN or higher) in a scientific field
  • 5+ years of clinical study management experience in the biopharmaceutical domain and at least three years of clinical study lead or project management experience. Total 8-10 years of relevant experience preferred.
  • At least two years of experience managing outsourced studies. Direct site monitoring and experience of managing audits or undertaking inspection preparedness preferred
  • Sound computer skills: proficient in Excel, Word, and EDC systems, and able to learn new systems and train others. Highly competent in an electronic environment (prior experience with eTMF systems highly advantageous)
  • Strong understanding of clinical trial domain and documentation management.
  • Understanding of GCLP and the conduct of clinical trial assays is advantageous
  • Strong understanding of laboratory matters as they pertain to clinical trials, and an ability to track and aggregate information from disparate systems (laboratory portals, EDC systems, Vendor tracking tools)
  • Ability to work with a high degree of initiative and independence while exercising appropriate judgement
  • Thorough knowledge  of  ICH/GCP guidelines, FDA requirements  for  INDs, NDAs, and drug approval process
  • An understanding of Quality Management and the Quality Cycle as it pertains to the clinical trial domain. A strong understanding of the lifecycle of Clinical Quality
  • Documentation (SOPs) and ability to manage in a document control environment
  • Meticulous attention to detail and ability to collaborate in development of clinical plans and execute to those plans in a timely manner
  • Very strong organizational, communication (oral and written), and interpersonal skills
  • Advanced problem-solving skills and ability to think creatively and apply innovative solutions to achieve the desired outcome
  • Multi-tasking skills and ability to manage multiple competing tasks, tracking multiple deadlines and competing activities


Job Details

Job Type: Direct Placement
Location: Brisbane, CA
Job ID: 19-11316
Date Updated: November 26, 2019