Clinical Contract Professional

hace 3 semanas

Alcobendas, Madrid, España BeiGene A tiempo completo

Job Summary

The Clinical Contract Professional will play a key role in the supervision of administration and negotiation processes for clinical site contracts, ensuring final contracts are delivered to agreed timelines, within Fair Market Value & in compliance with relevant legal & and regulatory requirements.

Main Responsibilities

  1. Oversight of planning, drafting, negotiating, tracking, and execution of site/investigator contracts which may be subcontracted to an external service provider or managed internally.
  2. Ensures final contracts are delivered to agreed timelines, within Fair Market Value & in compliance with relevant legal and regulatory requirements.
  3. Provide study-level oversight and guidance for clinical site contract negotiations, identify any potential risks, and be accountable for the overall contracting timelines/lifecycle in various regions.
  4. Serve as the study-specific point of contact with the BeiGene Clinical Operations team and legal team on site/investigator contract and budget matters.
  5. On a regional level, oversee a team of Site Contract Associates to ensure contracts in the region are completed per company standards/timelines. Implement mitigation plans as necessary in the assigned region.
  6. Serve as an escalation point for unresponsive sites, site budget negotiations and ensure costs are approved within BeiGene FMV standards.
  7. Functional line management of Contract Associates or equivalent and delivers individual and group feedback to support ongoing development.
  8. Adapts CBO's plan and priorities to address resource and operational challenges
  9. Organizes and prioritizes multiple initiatives and sets clear plans for delivery
  10. Effectively escalate/communicate to stakeholders and clinical teams in a professional and timely manner regarding contract issues that could impact project deliverables. Responsible for management and administration of contracts and ensures compliance with corporate policies.
  11. Serve as a backup to Site Contract Associates, as needed to handle out-of-office coverage.
  12. Ensure proper delivery of fully executed clinical site contracts to CBO Payments teams and liaison with CBO payments team, as necessary.
  13. Provide substantive guidance, monitoring, and support regarding clinical site contract deliverables, including undertaking activities identified in the CBO Roles/Responsibilities and/or Study Management Plan.
  14. Review, apply, and maintain BeiGene Playbook to enhance the efficiency of negotiation in conjunction with BeiGene Legal.
  15. Responsible for overseeing a Clinical Research Organization responsible for contract negotiations (if applicable).
  16. Responsible for clinical contract management, study metric tracking and reporting.
  17. Active participant in various study meetings.
  18. Collect site-specific contract/budget information and contribute to the maintenance of contract/budget intelligence tools.
  19. Prepare program/study status reports.
  20. Maintains a system for tracking progress and status of clinical budget/contracts.
  21. Support activities of various contracts and subsequent contract amendments note to files and other contract-related requests.
  22. Assist colleagues with the resolution of problems related to site budget, contract terms and conditions, compliance with BeiGene policy, and any other site contract-related issues.
  23. Deliver training to CBO colleagues or other Business Units as needed.
  24. Performs other duties as assigned by management.
  25. Works on Fair Market Value (FMV) analysis and processing of FMV exceptions (as needed).
  26. Provides cost benchmarking for clinical budget activities using industry-based system analysis (as needed).
  27. Develop and maintain tracking of negotiated savings as it relates to investigator budgets.
  28. Presents initiatives to improve team performance effectively.

Requirements

  • Bachelor's degree or equivalent work experience; a Health Care, business, legal, or scientific discipline preferred.
  • Significant (at least 5 years) Clinical Research and/or contract/budget experience.
  • Good knowledge of ICH-GCP, pharmaceutical related regulations and laws; Good understanding of clinical trial contracting process, and relevant clinical operation practices;
  • Awareness and understanding of compliance and regulatory matters in clinical research.
  • Proven negotiation, interpersonal and business skills.
  • Strong planning and organizational skills and the ability to work independently and effectively in a dynamic environment with competing priorities.
  • Sense of urgency and strong goal orientation; track-record of meeting deadlines and goals.
  • Strong written and verbal communication including written and verbal fluency in English and local language (if not English) and interpersonal skills, including conflict resolution and problem solving.
  • Proactive and positive team player. Able to maintain high performance during times of ambiguity and change in the work environment.
  • Experience in financial, budget, cost management/analysis, accounting, and/or financial planning skills are desirable
  • Has knowledge of Intellectual Property issues, Publication issues, Indemnification issues and other standard issues of site contracts within the clinical research area.
  • Must be willing to work in a fast-paced environment with time-sensitive material.
  • Demonstrated ability to work effectively at all levels of an organization.

Computer Skills:

Microsoft Office apps, CTMS, Contract Lifecycle Management System, Veeva, Jira, Beep/Sharepoint

Travel:

Yes, 10%

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