Biotecnologia à Italie

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Oncology-focused Global Pharmaceutical company

Under the guidance of the Manager, Site Contracts and Budgets, this position will be responsible for driving the tactical delivery of assigned studies or programs for the Global Clinical Study Support Department. They will participate on a project team to deliver contract and budget negotiations on time and in accordance with applicable financial, contractual, and pharmaceutical R&D industry standards and regulations.

1. Develop site-specific Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), or other related contractual documents (collectively, the “contractual documents”)
2. Negotiate contractual documents using the established negotiation and escalation plan
3. Track the progress and status of contractual negotiations and prepare appropriate status reports as required
4. Facilitate the execution of contractual documents between the investigator, site, and Client
5. Serve as a mentor to new or junior staff, providing required project-specific training and addressing project questions/issues
6. Work collaboratively with the study team to set up and maintain contract management systems that facilitate the creation, distribution, negotiation, and execution of contractual documents
7. Serve as the primary point of contact and escalation for investigator sites, the global negotiation network, or study team members (e.g., CRAs) during the negotiation of contractual documents
8. Assist with preparation of performance metrics (e.g., median cycle times)
9. Notify management, as appropriate, of any out-of-scope requests or activities, timeline changes, or resource constraints
10. Other duties as assigned

• B.A./B.S. preferably in a business or science/health care field, nursing degree, or equivalent degree
• Five (5) years of prior experience in a client service role at a biotechnology or pharmaceutical company, CRO, or other organization supporting clinical research or healthcare activities
• Prior Study Start-Up experience at a biotechnology or pharmaceutical company, CRO, or other organization supporting clinical research or healthcare activities
• Prior experience working with electronic document management system(s) or similar portal environment desired