Clinical Research Contracts Specialist

hace 1 semana

Madrid Centro, Madrid, España ESP Labcorp Development A tiempo completo
Job Description

As a leading global contract research organization (CRO), ESP Labcorp Development 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, ESP Labcorp Development is transforming drug and device development for partners and patients across the globe.

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

Key Responsibilities:
  1. Adhere to Standard Operating Procedures (SOPs)
  2. Perform Daily Tracking, Negotiation, and Approval of Site Agreements and Site Agreement Templates
  3. Timely Update of the Departmental Site Agreement Management System (SAMS)
  4. Identify and Escalate Issues to Line Manager for Review
  5. Confirm Quality of Tasks Delegated to and Completed by Contracts Associate
  6. Manage Assigned Studies with Careful Compliance with Internal Processes and Procedures
  7. Responsible for Timely Updating of the Departmental Contract Tracking System
  8. Perform Contract Administration Functions, Including Assisting with Obtaining Approvals on Authorization Forms
  9. Maintain a Contract Tracking System to Report Contract Status Updates and Signing Status
  10. Provide Notice of All Executed Contracts to Appropriate Team Members Along with Contract Values
  11. Scan and File Executed Contracts in the Shared Electronic Storage Area in a Timely Manner
  12. Support Line Manager with Departmental Goals, Objectives, and Initiatives
  13. Provide Management with Regular Status Updates on All Open Contracts and Any Outstanding Issues
  14. Draft, Negotiate, Review, and Process Contracts in a Commercially Reasonable Manner
  15. Negotiate Contractual Terms with Other Contracting Parties in a Professional Manner
  16. Apply Knowledge of the Principles of ICH GCP to Their Work and Follow Quality Standard Procedures
  17. Identify Potential Obstacles in the Contracting Process and Request Assistance as Necessary
  18. Work Closely with Appropriate Staff to Keep Them Informed of Progress of Agreements
  19. Provide Support to Other Site Agreements Staff and Assist Internal Staff with Contractual Inquiries
  20. Facilitate the Internal Review/Revision/Sign Off Process on Contracts
  21. Coordinate and Communicate with Clinical Study Teams Regarding Contract Details and Timelines
Requirements:
  1. Work Experience in Clinical Research, Including a Strong Working Knowledge of the ICH Guidelines and FDA, IRB/IEC Regulations
  2. Minimum Years of Experience, or an Equivalent Combination of Education and Experience to Successfully Perform the Key Responsibilities of the Job
  3. University/College Degree
  4. Fluent in Local Language and English

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