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Senior Associate, Clinical Contracts and Budgets Specialist
2 months ago
We are seeking a highly skilled and experienced Senior Associate to join our Clinical Contracts and Budgets team at Amgen SA. As a key member of our team, you will play a critical role in supporting clinical site management activities, including managing clinical contract and budget negotiations for Amgen Sponsored Trials (ASTs), Non-Amgen Sponsored Clinical Research (NASCR), and Expanded Access Programs (EAP).
Key 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 clinical site/legal meetings to resolve contract issues and negotiate site study budgets.
- Review and negotiate site budgets, ensuring compliance with Fair Market Value (FMV) guidelines.
- Configure site contracts and study-specific requirements into eClinical payment portals.
- Manage internal collaborator needs and expectations through regular communication.
- Contribute to global and local departmental goals, seeking opportunities for operational efficiency.
- Ensure ISSs are supported in alignment with global SOPs and supporting documentation.
- Partner with TA/Medical staff to support NASCR deliverables.
- Participate in set-up activities and sponsor support to SOPs.
- Partner with Global/Regional Operations representatives regarding drug forecasting and ancillary supplies.
- Support the collection of ISS Approval Package (ISSAP) documents and forward for signature approval.
- Enter data into and maintain source systems, tracking essential documentation and archiving in EPIC.
- Bachelor's Degree
- 2 years of experience in pharmaceutical/health industry
- 1+ years of 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
