Contracts Specialist 2, Site Agreements

hace 6 meses

Madrid, España ESP Labcorp Development S.A.U. A tiempo completo

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

We are looking for Contracts Specialist 2 to join our EMEA Site Agreements team. This is full time and permanent position, might be fully remote or office-based.


Prepares and negotiates and assists in the execution and retention of site agreements, confidentiality agreements, letters of indemnification and other contracts for Sponsors who contract Fortrea to perform this service. Maintains and contributes to contracts tracking and status systems and supports maintenance of paper and electronic file systems. Responsible for following 
SOPs including but not limited to departmental SOPs, as well as completing study-related duties in accordance with the processes set forth in the relevant process document.


Summary of Responsibilities:
• Responsible for adherence to standard operating procedures (SOPs)
• Perform the following, with minimal guidance from line management or more experienced colleagues: daily tracking, negotiation and approval of Site Agreements and Site Agreement templates (as applicable) for clinical study teams; timely updating of the departmental Site Agreement Management System (“SAMS”) or any other system required for use on a particular 
study.
• Identify and escalate issues (as defined in departmental processes) that must be escalated to line manager for review. 
• Confirm quality of tasks delegated to and completed by Contracts Associate.
• Manage assigned studies with careful compliance with internal processes and procedures, or otherwise according to specified Sponsor requirements.
• Responsible for the timely updating of the departmental contract tracking system.
• Performs contract administration functions including assisting with obtaining approvals on authorization forms as required; maintaining a contract tracking system to report contract status 
updates and signing status; providing notice of all executed contracts to the appropriate team members along with contract values; and scanning and filing executed contracts in the shared 
electronic storage area in a timely manner for access by other staff members.
• Support line manager with departmental goals, objectives, and initiatives in a positive and flexible way.
• Provides management with regular status updates on all open contracts and any outstanding issues.
• Drafts, negotiates, reviews, and processes contracts in a commercially reasonably manner that protects Fortrea’s fundamental interests and in accordance with departmental practices and policies. Produces and negotiates contracts that accurately reflect Fortrea’s obligations or rights 
and understandings with third parties. 
• Negotiates contractual terms with other contracting parties in a professional manner.
• Ability to apply knowledge of the principles of ICH GCP to their work and follow quality standard procedures.
• Identifies potential obstacles in the contracting process promptly and requests assistance of line manager, project management staff, Business Development staff, Budgets & Proposals staff or higher management as necessary to minimize delays and to facilitate the prompt conclusion of 
contractual negotiations.
• Works closely with appropriate staff to keep them informed of progress of agreements and to avoid any delays in execution.
• Provides support to other Site Agreements staff and assists internal staff with contractual inquiries as required.
• Facilitates the internal review/revision/sign off process on contracts prior to forwarding to external parties.
• Coordinate and communicate with clinical study teams in a timely manner regarding contract details and timelines, as well as contract status reporting to ensure quick approval of templates and contracts.
• Support line manager with departmental goals, objectives and initiatives in a positive and flexible way.
 

Requirements:

Work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations University/College degree Flunet local language and English

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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