Site Contract Associate
2 settimane fa
Parexel is a leading global biopharmaceutical services company that helps clients transform scientific discoveries into new treatments. We are committed to our values: Patients First, Quality, Respect, Empowerment & Accountability.
Job Summary:We are seeking a highly skilled Site Contract Associate to join our team in Italy. The successful candidate will be responsible for negotiating study-specific generic and country Clinical Site Agreement (CSA) templates with sponsors and supporting the Project Lead in negotiating country budgets with sponsors.
Key Responsibilities:- Develop study-specific CSA strategies and negotiate templates with sponsors
- Support the Project Lead in negotiating country budgets with sponsors
- Manage CSA activities and liaise with the Project Lead, GRO Lead, and sponsors to ensure CSA start-up deliverables are met
- Coordinate local CTS/CRA activities and provide required CSA country templates
- Communicate CSA strategy, turnaround timelines, CTMS tracking requirements, and budget information/updates with assigned CTS/CRAs
- Provide agreed study and country CSA templates to local CTS/CRA for country-specific adaptation
- Coordinate interaction between GRO Lead, Project Lead, and sponsors, including overall timeline management for CSAs
- Coordinate overall CSA process with assigned CTS/CRA and status reporting to GRO-Lead/Project Lead
- Provide updates about template amendments, process changes, investigator fees, local requirements, etc. to ensure relevant CSA database is up-to-date
- Maintain comprehensive language tracker
- Identify and address issues proactively in a timely manner
- Take initiative, work independently, and delegate tasks effectively
- Experienced CRA, CTS, or senior person with a legal or business degree or other relevant experience
- Global Site Contract Lead experience
- Excellent computer and internet skills, including MS-Office products such as Excel, Word
- Strong negotiation, diplomacy, team leadership skills, and excellent organizational ability
- Excellent interpersonal, verbal, and written communication skills
- Ability to motivate individuals and teams
- Ability to work in a virtual team environment
- Ability to complete tasks accurately, timely, and effectively manage multiple tasks
- Shows commitment to and performs consistently high-quality work
- Degree in business, legal, or life science or other relevant work experience in Contracting, Clinical Operations, or in Legal (Paralegal)
- Fluent in written and spoken English and Italian
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