Site Contract Specialist

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

Descrizione del lavoro

An established industry player in the pharmaceutical sector is seeking a skilled professional to join their Global Clinical Study Support Department. This role is pivotal in driving the tactical delivery of assigned studies, focusing on contract and budget negotiations while adhering to industry standards. The ideal candidate will have a strong background in client services within biotechnology or pharmaceuticals and will play a key role in mentoring junior staff. If you are passionate about making a difference in clinical research and thrive in a collaborative environment, this opportunity is perfect for you.

Competenze

• 5+ years in a client service role in biotechnology or pharmaceutical companies.
• Experience with Study Start-Up processes and contract management.

Mansioni

• Develop and negotiate Confidential Disclosure Agreements and Clinical Trial Agreements.
• Track the progress of contractual negotiations and mentor junior staff.

Conoscenze

Contract Negotiation

Project Management

Client Service

Mentoring

Formazione

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

Strumenti

Electronic Document Management Systems

Descrizione del lavoro

Job Description

Join an oncology-focused global pharmaceutical company. Under the guidance of the Manager, Site Contracts and Budgets, this position is 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 ensure timely contract and budget negotiations, adhering to 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.
2. Negotiate contractual documents using established negotiation and escalation plans.
3. Track the progress and status of contractual negotiations and prepare status reports.
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. Work with the study team to set up and maintain contract management systems for creating, distributing, negotiating, and executing contractual documents.
7. Serve as the primary contact and escalation point during negotiations with investigator sites, the global negotiation network, or study team members such as CRAs.
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. preferably in a business, science, healthcare field, nursing, or an equivalent degree.
• Minimum of five (5) years of experience in a client service role within a biotechnology or pharmaceutical company, CRO, or related organization supporting clinical research or healthcare activities.
• Experience with Study Start-Up processes at relevant organizations.
• Experience with electronic document management systems or similar portal environments is desired.