Clinical Contracts and Budgets Specialist

1 week ago

Mississauga, Ontario, Canada Amgen SA Full time

At Amgen, we are dedicated to using science and technology to address the most pressing healthcare challenges. As a leading biotechnology company, our goal is to reach over 10 million patients worldwide.

This role is an exciting opportunity to support clinical site management activities by managing all site-related clinical contract and budget negotiations for Amgen Sponsored Trials (ASTs), Non-Amgen Sponsored Clinical Research (NASCR) which includes Investigator Sponsored Studies (ISS) and Expanded Access Program (EAP).

Job Description
  • Main Responsibilities:
  • Manage the clinical site contracting process, including contract and amendment preparation, negotiation, escalation, tracking, and execution for ASTs, NASCRs, ISS, and EAP.
  • Participate in appropriate clinical site/legal meetings as required to resolve contract issues.
  • Lead the review of the site budget template with the Regional Clinical Trial Manager for country feedback on FMV (Fair Market Value).
  • Negotiate site study budget from the base budget and payment landmarks using appropriate guidelines.
  • Advance contract and budget issues to Legal, Pricing Group, and/or Regional Clinical Trial Manager as appropriate.
  • Configure site contracts and study-specific requirements into the eClinical payment portal.
  • Manage internal collaborator needs and expectations through regular communication regarding progress and status of pending contract and payment requests.
  • Actively contribute to global and local departmental goals.
  • Seek opportunities and standard methodologies with local and regional partners that will contribute to overall operational efficiency.
  • Partner with TA/Medical staff to ensure timely and appropriate support of NASCR deliverables.
  • Support the collection of ISS Approval Package (ISSAP) documents and forward them for signature approval.
  • Enter data (including milestone tracking and enrollment status) into and maintain source systems.
Requirements
  • Bachelor's Degree
  • 2 years of experience in the pharmaceutical/health industry
Preferred Qualifications
  • 1+ years experience in contracting, finance administration, project management, or other experience in life sciences or medical field
  • Work experience in clinical research acquired while working on clinical trials for a biotech/pharma company or CRO
  • Prior experience or robust understanding of clinical site contracting and payment processes
  • Ability to work independently with little supervision as well as in a team environment
  • Strong negotiation skills, analytical and presentation skills
  • Excellent written and oral communication skills
  • Attention to detail
  • Persistent, tactful, and persuasive
  • Proficiency with computer/database systems
  • Strong organizational skills with the ability to prioritize
  • Knowledge of relevant therapeutic or product area
What We Offer

In addition to the competitive salary range of $85,000-$115,000 per year, Amgen offers comprehensive Total Rewards Plans aligned with local industry standards.

We value diversity and inclusion at Amgen and welcome applications from candidates without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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