Senior Associate Study Manager (JP4653)

Location: Thousand Oaks, Ca
Date Posted: 08-26-2018
Job Title: Senior Associate Study Manager (JP4653)
Location:  Thousand Oaks, Ca. or South San Francisco, CA 
Employment Type: Contract
Duration: 12 months with likely extensions
Business Unit: Medical Sciences
 
3Key Consulting is looking for a Senior Associate Study Manager  for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA
 
Ideal Candidate -
• Phase 1 experience
• Minimum 5 years experience in clinical research management
• Oncology trial 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)
 
Why this position is open:
Backfill for EW that was converted to an Amgen FTE
 
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.
 
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
 
Employee Value Proposition:
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
 
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 and in-person

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 welcome to share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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