Clinical Trial Contracts Administrator

3 months ago

Mississauga, Canada Amgen Full time

**HOW MIGHT YOU DEFY IMAGINATION?**

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Clinical Trial Contracts Administrator

**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).

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.

**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.
- 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.

**Win**:
**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The contracts professional we seek is an individual with these qualifications.

**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

**Thrive**:
**What you can expect of us**

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.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and annual company-wide shutdowns
- Flexible wo

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