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Clinical Trial Contracts Administrator
Company | Amgen |
Address | Mississauga, Ontario, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-08-12 |
Posted at | 9 months ago |
Career Category
- Participates in appropriate clinical site/legal meetings as required to resolve contract issues.
- Participates in set-up activities and sponsor support to the SOP.
- 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.
- Enter data (including milestone tracking and enrollment status) into and maintain source systems.
- Track essential documentation and archive in EPIC.
- Partners with TA/Medical staff to ensure timely and appropriate support of NASCR deliverables.
- Negotiates site study budget from the base budget and payment milestones using appropriate guidelines.
- Ensures ISSs are supported in alignment with global SOP and other supporting documentation.
- Manages the clinical site contracting process, including contract and amendment preparation, negotiation, escalation, tracking and execution for ASTs, NASCRs, ISS and EAP
- Support the collection of ISS Approval Package (ISSAP) documents and forward for signature approval.
- Seeks opportunities and standard methodologies with local and regional partners that will contribute to overall operational efficiency.
- Partner with Global /Regional Operations representative regarding drug forecasting including ancillary supplies, clinical trial labelling activities, expiry dates/memos as appropriate.
- Actively contributes to global and local departmental goals.
- Leads the review of the site budget template with the Regional Clinical Trial Manager for country feedback on FMV (Fair Market Value).
- Manages internal collaborator needs and expectations through regular communication regarding progress and status of pending contract and payment requests.
- Excellent written and oral communication skills
- Strong organizational skills with the ability to prioritize
- Persistent, tactful, and persuasive
- Ability to work independently with little supervision as well as in a team environment
- Strong negotiation skills, analytical and presentation skills
- Proficiency with computer/database systems
- 1+ years experience in contracting, finance administration, project management, or other experience in life sciences or medical field
- Attention to detail
- Knowledge of relevant therapeutic or product area
- 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
- Stock-based long-term incentives
- Flexible work models, including remote work arrangements, where possible
- Award-winning time-off plans and annual company-wide shutdowns
- 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
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