Clinical Research Study Manager

Location
Thousand Oaks, California
Salary
$90,000 - $110,000
Posted
Mar 13, 2019
Ref
949580
Required Education
Masters Degree/MBA
Position Type
Contract

Top 3 Must Have Skill Sets:: * 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) 


Basic Qualifications: 

  • Doctorate Degree OR Master's Degree and 3 years of Clinical experience OR Bachelor's Degree and 5 years of Clinical experience OR Associate's degree and 10 years of Clinical experience OR High school diploma/GED and 12 years of Clinical experience