Site Contract Specialist

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

Descrizione del lavoro

An innovative global pharmaceutical company is seeking a dedicated professional to join their Clinical Study Support Department. This role is pivotal in ensuring timely contract and budget negotiations for clinical trials, requiring a strong background in client service and project management. Ideal candidates will have experience in the biotechnology or pharmaceutical sectors and a knack for navigating complex contractual documents. This position offers the opportunity to make a significant impact in the field of clinical research while collaborating with a dynamic team. If you have a passion for healthcare and a drive to excel in a fast-paced environment, this is the role for you.

Competenze

• 5+ years of experience in client service within biotech or pharma.
• Experience with contract negotiations and project management.

Mansioni

• Develop and negotiate Confidential Disclosure Agreements and Clinical Trial Agreements.
• Track progress of contractual negotiations and prepare status reports.
• Mentor new staff and assist with performance metrics preparation.

Conoscenze

Contract Negotiation

Project Management

Client Service

Communication Skills

Formazione

Bachelor's Degree in Business or Science

Nursing Degree

Strumenti

Electronic Document Management Systems

Descrizione del lavoro

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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.

Duties and Responsibilities

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 the 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. Perform other duties as assigned.

Requirements:

• 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.
• Experience working with electronic document management systems or similar portal environments is desired.