Clinical Research Study Manager (JP4368)

Location: Thousand Oaks, Ca
Date Posted: 06-11-2018
Job Title:  Clinical Research Study Manager (JP4368)
Location: Thousand Oaks, Ca
Type: Contract
Duration: 12 months with likely extension
3Key Consulting Inc. is recruiting for a Clinical Research Study Manager to support early development clinical trial for a global, CA-based, bio-pharmaceutical company.
Job Description:
  • Planning, management and reporting of clinical studies conducted by Early Development or the Functional Service Provider through oversight of cross-functional study activities
  • Identification and resolution of issues
  • Communication of study timelines and deliverables ensuring studies are conducted in accordance with SOPs, GCP and regulatory guidance
  • Contributing to the First in Human Portal document/Global Development Plan
  • Contributing to/authoring protocols, relevant sections of annual safety reports, clinical study reports, and publications
  • Management and/or oversight of study budget, timelines and insourcing/outsourcing partners to the required standards 
Must Have Skills:
  • Phase 1 experience
  • Minimum 5 years of experience in clinical research management
  • Oncology trail experience
  • Global Trial experience
  • Strong scientific background- academic or experience in clinical research setting.
  • Protocol writing experience- a plus
  • Strong authoring protocols experience in clinical study reports.
Preferred Qualifications:
  • MS or RN
  • 7+ years of experience in life sciences or medically related field
  • 4+ years of bio-pharmaceutical clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials at academic institutions or working on clinical trials in a biotech, pharmaceutical or CRO company
  • Management experience of direct reports
  • Experience in oversight of Functional Service Providers, outside vendors (CRO’s, central labs, imaging vendors, etc) 

Red Flags:
  • Consistent short tenured positions/jobs
  • CRO’s are more service providers and are more heavy in the PM side of things and tend to not be best fit.
Interview Process:
Candidates will receive a phone screen, and ideal candidates will be invited to a F2F interview with the South San Francisco study management team.
3KC Talent Acquisition Team
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