Clinical Study Manager (JP4416)

Location: South San Francisco, ca
Date Posted: 06-21-2018
Job Title:  Clinical Study Manager (JP4416)
Location: South San Francisco, CA.
Employment Type:  Contract
Business Unit:  Medical Sciences
Duration: 1+ yearss (likely extensions)
 
3Key Consulting Inc. is recruiting for a Clinical Study Manager with biotech/pharmaceutical oncology phase 1 clinical research/trial experience, managerial experience and scientific background with 7+ years’ experience for a global, CA-based, bio-pharmaceutical company.
 
Job Description:
The ideal candidate will have:
  • 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.
 
The data management manager will be responsible for:
  • 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.
 
Top 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
 
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
 
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 heavier in the PM side of things and tend to not stronger candidate.
 
Interview process:
Telephone followed by 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 also 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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