BASIC QUALIFICATIONS:

• Bachelors Degree
• 2 years of experience in 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 YOU WILL DO

Let’s do this. Let’s change the world. In this vital role you will 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).

RESPONSIBILITIES:

• Manages the clinical site contracting process, including contract and amendment preparation, negotiation, escalation, tracking and execution for ASTs, NASCRs, ISS and EAP
• Participates in appropriate clinical site/legal meetings as required to resolve contract issues.
• Leads the review of the site budget template with the Regional Clinical Trial Manager for country feedback on FMV (Fair Market Value).
• Negotiates site study budget from the base budget and payment landmarks using appropriate guidelines.
• Advances contract and budget issues to Legal, Pricing Group, and/or Regional Clinical Trial Manager as appropriate.
• Configures site contracts and study specific requirements into eClinical payment portal.
• Manages internal collaborator needs and expectations through regular communication regarding progress and status of pending contract and payment requests.
• Actively contributes to global and local departmental goals.
• Seeks opportunities and standard methodologies with local and regional partners that will contribute to overall operational efficiency.
• Ensures ISSs are supported in alignment with global SOP and other supporting documentation.
• Partners with TA/Medical staff to ensure timely and appropriate support of NASCR deliverables.
• Participates in set-up activities and sponsor support to the SOP.
• Partner with Global /Regional Operations representative regarding drug forecasting including ancillary supplies, clinical trial labelling activities, expiry dates/memos as appropriate.
• Support the collection of ISS Approval Package (ISSAP) documents and forward for signature approval.
• Enter data (including milestone tracking and enrollment status) into and maintain source systems.
• Track essential documentation and archive in EPIC.