Clinical Research Study Manager (JP4759)

Location: Thousand Oaks, ca
Date Posted: 09-26-2018
Job Title:  Clinical Research Study Manager (JP4759)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  Medical Sciences
Duration: 1+ years (likely extensions)
 
3Key Consulting Inc. is recruiting for a Clinical Research Study Manager with 5+ years’ experience in clinical research management, 3+ years’ experience in clinical pharmacology trials (phase 1 in a CRU, etc.), and oncology trial experience for a global, CA-based, bio-pharmaceutical company.
 
Job Description:
We are looking for a Clinical Research Study Manager with the following background:
  • Individuals with at least 3+ years’ experience in clinical pharmacology trials (.i.e Bioequivalent, Drug-Drug-Interaction, Food Effect, etc.).
  • Experience in working with Phase 1 Clinical Research Unit (CRU).
  • Experience in managing outsourcing vendors (solicit RFPs/bids, developing specifications, managing vendor project managers & delivery)
  • 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.
 
Top Must-Have Skill Sets:
  • Individuals with at least 3+ years’ experience in clinical pharmacology trials (ie Bioequivalent, Drug-Drug-Interaction, Food Effect, etc.
  • Experience in working with Phase 1 Clinical Research Unit (CRU).
  • Experience in managing outsourcing vendors (solicit RFPs/bids, developing specifications, managing vendor project managers & delivery).
  • 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.
 
Day to Day 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
 
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
 
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.).
 
Why This Position Is Open:
Supplement additional workload on team
 
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:
Telephone followed by in-person interview.
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are also welcome to share this posting with anyone you think might be interested in applying for this role.
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
or
this job portal is powered by CATS