Clinical Research Study Manager

Thousand Oaks, CA 91320

Posted: 08/27/2018 Employment Type: Contract Industry: Biotech Job Number: 4702

Ideal Candidate:
  • Phase 1 experience 
  • Minimum 5 years’ 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. 

 

Responsibilities
  • 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 

 

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) 
Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.