Senior Clinical Contracts Specialist

BeiGene; United States; Remote; USD 65.000 - 81.000; Vollzeit

Zusammenfassung

BeOne is seeking a Senior Contract Associate to draft, negotiate, and finalize complex Clinical Site Contracts across the lifecycle of clinical trials. The role includes data entry in CMS, adherence to timelines, and close collaboration with GCO, Legal, and Investigator Sites to ensure FMV compliance.

The position requires robust organization, proactive communication, and ability to perform under tight deadlines in a fast-paced environment.

Aufgaben

• Prepare, negotiate, and finalize clinical trial agreements, ancillary agreements and amendments of company sponsored studies through direct communication with sites.
• Responsible for execution of contracts against planned timelines and targets.
• Manage budget grid in the contract. Ensure the cost calculation are consistent with protocol and agreed with site.
• Demonstrates an understanding of records management requirements for contract documents
• Complete quality check (QC) of final approved contract and budget documents, and initiates signature process of assigned contracts to the responsible signing parties.
• Ensure final contracts are delivered to agreed timelines, within Fair Market Value & in compliance with relevant legal and regulatory requirements
• Serve as the primary point of contact between CBO and Global Clinical Operations (GCO), Legal, Investigator Sites and external service providers in accordance with the study related activities to meet business needs;
• Collect and maintain country and site intelligence information for each country and/or site, and prepares country/site specific contract process flows as needed;
• Forecast, set, track and communicate fully executed contract planned dates, and make all efforts to achieve the set planned date, ensuring the CM and study teams are proactively informed of changes and/or risks to the projected dates;
• Liaise with CM and BeOne legal to review and update contract template(s) as needed, including Master Clinical Trial Agreements/Clinical Trial Agreements/Project Agreements or any other Site agreement template(s);
• Liaise with CM and BeOne legal to contribute updates to the BeOne Legal Playbook guidance document as needed;
• Liaise with Investigator Payment Management (IPM) team to ensure site contracts, including investigator site budgets, are approved and executed in accordance with CBO guidelines and BeOne policies;
• Ensure all investigator contracts are reviewed and approved by legal and/or delegate prior to execution, and in accordance with CBO and BeOne legal guidelines;
• Communicate legal and budgetary issues to internal and external parties per department guidelines, as needed;
• Perform legal translation of contract language for Sites, as needed;
• Maintain active and regular communication with site personnel and internal BeOne partners, with regular progress tracking and updates provided throughout the contract lifecycle;
• Prepare subsequent contract amendments, note to files and other related contract documents, as needed;
• Escalates contracting issues and/or potential delays to internal and external stakeholders, as necessary;
• Attend and actively participate in Investigator Site, project related, CBO, and other meetings, as necessary;
• Update and maintain CBO trackers with real-time updates on a regular basis, complete CBO related filing and distribution of contract documents, and maintain Contract Management System (CMS) records, in accordance with CBO and BeOne policies;
• Provides a handoff to the project/payment

Jobbeschreibung

BeOne is seeking a Senior Contract Associate to draft, negotiate, and finalize complex Clinical Site Contracts across the lifecycle of clinical trials. The role includes data entry in CMS, adherence to timelines, and close collaboration with GCO, Legal, and Investigator Sites to ensure FMV compliance.

The position requires robust organization, proactive communication, and ability to perform under tight deadlines in a fast-paced environment.