Site Contract Specialist

Advanced Clinical; Madrid; Presencial; EUR 50.000 - 75.000; Jornada completa

Descripción de la vacante

A global pharmaceutical company is seeking a Clinical Contract Manager to oversee contract negotiations and ensure compliance with industry regulations. The ideal candidate will contribute to contractual document preparation while mentoring junior team members and collaborating with project teams in a dynamic environment.

Formación

• Five years of experience in client service roles within biotech or pharma.
• Experience in Study Start-Up phases at relevant organizations.
• Working knowledge of contract negotiation processes.

Responsabilidades

• Develop site-specific Confidential Disclosure Agreements (CDAs) and Clinical Trial Agreements (CTAs).
• Negotiate contracts and track negotiation statuses.
• Mentor junior staff and set up contract management systems.

Conocimientos

Negotiation

Contract Management

Team Collaboration

Educación

B.A. / B.S. in business or health care field

Herramientas

Electronic Document Management System

Descripción del empleo

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

• Develop site-specific Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), or other related contractual documents (collectively, the “contractual documents”)
• Negotiate contractual documents using the established negotiation and escalation plan
• Track the progress and status of contractual negotiations and prepare appropriate status reports as required
• Facilitate the execution of contractual documents between the investigator, site, and Client
• Serve as a mentor to new or junior staff, providing required project specific training and addressing project questions / issues
• Work collaboratively with study team to set up and maintain contract management systems that facilitate the creation, distribution, negotiation, and execution of contractual documents
• 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
• Assist with preparation of performance metrics (i.e. median cycle times)
• Notify management, as appropriate, of any out-of-scope requests or activities, timeline changes, or resource constraints
• 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
• Prior experience in working with electronic document management system(s) or similar portal environment desired

J-18808-Ljbffr

J-18808-Ljbffr