Clinical Contracts Specialist

hace 2 meses

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

We are seeking a highly skilled Contracts Specialist 2 to join our EMEA Site Agreements team at ESP Labcorp Development S.A.U. This is a full-time and permanent position, which may be fully remote or office-based.

Key Responsibilities
  • Prepare and negotiate site agreements, confidentiality agreements, letters of indemnification, and other contracts for sponsors who contract us to perform this service.
  • Maintain and contribute to contracts tracking and status systems, and support the maintenance of paper and electronic file systems.
  • Responsible for following standard operating procedures (SOPs), including departmental SOPs, and completing study-related duties in accordance with the relevant process document.
  • Identify and escalate issues that must be escalated to line management for review.
  • Confirm the quality of tasks delegated to and completed by Contracts Associates.
  • 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.
  • Perform 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 management with departmental goals, objectives, and initiatives in a positive and flexible way.
  • Provide management with regular status updates on all open contracts and any outstanding issues.
  • Draft, negotiate, review, and process contracts in a commercially reasonable manner that protects our fundamental interests and in accordance with departmental practices and policies.
  • Negotiate contractual terms with other contracting parties in a professional manner.
  • Apply knowledge of the principles of ICH GCP to their work and follow quality standard procedures.
  • Identify potential obstacles in the contracting process promptly and request assistance of line management, 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.
  • Work closely with appropriate staff to keep them informed of progress of agreements and to avoid any delays in execution.
  • Provide support to other Site Agreements staff and assist internal staff with contractual inquiries as required.
  • Facilitate 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.
Requirements
  • Work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.
  • University/College degree.
  • Fluent local language and English.

ESP Labcorp Development S.A.U. 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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