Contracts Specialist 2, Site Agreements

hace 7 días

Madrid, 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.

Job Overview:

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.

• Complies with and fulfils corporate requirements of the position including, inputting activities in
Timesheets, conducting all required training and documenting training in training systems, and
preparing and submitting any company expense reports for reimbursement in a timely manner.

• 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.

• Assist in development and ongoing improvem

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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