Site Contract Specialist

JR Italy; Venezia; In loco; EUR 40.000 - 80.000; Tempo pieno

Descrizione del lavoro

An innovative global pharmaceutical company seeks a Clinical Contracts Specialist to drive contract negotiations and support oncology studies. This role involves collaborating with project teams to ensure timely delivery of contractual documents while adhering to financial and regulatory standards. The ideal candidate will have extensive experience in clinical research, exceptional negotiation skills, and a passion for mentoring junior staff. Join a dynamic team that values collaboration and excellence in the ever-evolving field of oncology research.

Competenze

• 5+ years in a client service role within clinical research or healthcare.
• Experience with Study Start-Up processes and contract management.

Mansioni

• Develop and negotiate site-specific Confidential Disclosure Agreements and Clinical Trial Agreements.
• Track negotiation progress and mentor junior staff.

Conoscenze

Contract Negotiation

Project Management

Client Service

Mentoring

Regulatory Compliance

Formazione

B.A./B.S. in Business, Science, Healthcare, or Nursing

Strumenti

Electronic Document Management Systems

Descrizione del lavoro

Job Description: Clinical Contracts Specialist

Join our 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 within the Global Clinical Study Support Department. The role involves participating in project teams to deliver contract and budget negotiations on time, adhering to financial, contractual, and pharmaceutical R&D standards and regulations.

Duties and Responsibilities

1. Develop site-specific Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), or other related contractual documents.
2. Negotiate contractual documents following established negotiation and escalation plans.
3. Track the progress and status of negotiations and prepare status reports as needed.
4. Facilitate the execution of contractual documents between investigators, sites, and clients.
5. Mentor new or junior staff, providing project-specific training and addressing questions/issues.
6. Collaborate with study teams to set up and maintain contract management systems for document creation, distribution, negotiation, and execution.
7. Serve as the primary contact and escalation point for investigator sites, the global negotiation network, and study team members during contract negotiations.
8. Assist in preparing performance metrics, such as median cycle times.
9. Notify management of out-of-scope requests, timeline changes, or resource constraints.
10. Perform other duties as assigned.

Requirements

• B.A./B.S. degree, preferably in a business, science, healthcare, or nursing field, or equivalent.
• At least five (5) years of experience in a client service role supporting clinical research or healthcare activities within a biotechnology or pharmaceutical company, CRO, or similar organization.
• Experience in Study Start-Up processes at a relevant organization.
• Experience with electronic document management systems or similar portals is desirable.