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Clinical Trial Contracts Administrator
2 weeks ago
Career Category
Clinical
**Job Description**:
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Clinical Trial Contracts Administrator (12-month contract, full time)
Reports to: Clinical Trial Oversight Manager
This is a hybrid role where you can work from our Mississauga office a couple times a month OR can be fully remote depending on your experience level with clinical contract administration and budget negotiations.
Live
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 milestones using appropriate guidelines.- Escalates 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 enrolment status) into and maintain source systems.- Track essential documentation and archive in EPIC.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The organized professional we seek is a strong negotiator with these qualifications.
Basic Qualifications:
- Bachelors Degree
Preferred Qualifications:
- 3+ 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 manage multiple priorities- Knowledge of relevant therapeutic or product area
Thrive
Some of the vast rewards of working here
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act- Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us
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