Senior Contract Associate

BeOne Medicines USA; United Kingdom; On-site; GBP 55,000 - 75,000; Full time

Job summary

BeOne Medicines USA seeks a Senior Contract Associate to draft, negotiate, and finalize complex clinical site contracts for trials in the United Kingdom. You will manage data entry into CMS, ensure timely delivery, and coordinate with Legal, GCO, and sites to meet project timelines.

The role requires experience with contract templates, budgeting, and regulatory compliance, in a fast-paced environment. Collaboration with cross-functional teams is essential to drive successful trial execution.

Qualifications

• Experience drafting and negotiating clinical trial contracts.
• Ability to manage contract budgets and timelines.
• Knowledge of regulatory requirements for clinical contracting.

Responsibilities

• Prepare, negotiate, and finalize clinical trial agreements and amendments with sites.
• Manage execution of contracts against planned timelines and targets.
• Maintain contract budgets and ensure costs align with protocol and site agreement.
• Perform QC of final contracts and initiate signature process with signing parties.
• Ensure contracts are delivered on time and compliant with legal requirements.
• Act as primary liaison between CBO, GCO, Legal, sites, and providers.
• Maintain country/site intelligence and contract process flows as needed.
• Coordinate UK costing activities through CPMS and iCT tools.

Skills

Contract negotiation

Clinical trial contracts

Budget management

Regulatory compliance

Tools

CMS (Contract Management System)

NIHR CPMS

iCT costing tool

Contract templates

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

The Senior Contract Associate is responsible for drafting, negotiating, and finalizing complex Clinical Site Contracts related to clinical trials throughout the lifecycle of the study, with focus on the United Kingdom market. Performs timely and accurate data entry into all Clinical Business Operations operating systems, including but not limited to the company Contract Management System (CMS). The Contract Associate is also responsible for meeting deliverables with high quality and within the project timelines. The contracting activity supported by the CBO team is fast-paced, with short deadlines and quick turnaround times therefore Contract Associate must be capable of managing priorities effectively, proactively communicating issues and working in a fast-paced environment.

Essential Functions of the Job:

• 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 Medicines 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 Medicines legal to contribute updates to the BeOne Medicines Legal Playbook guidance document as needed;
• Liaise with Clinical Site Budgets and Payment team to ensure site contracts, including investigator site budgets, are approved and executed in accordance with CBO guidelines and BeOne Medicines policies;
• Ensure all investigator contracts are reviewed and approved by legal and/or delegate prior to execution, and in accordance with CBO and BeOne Medicines 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 Medicines 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 Medicines policies;
• Provides a handoff to the project/payment team upon execution of a site's final contractual documents
• Coordinate UK costing and contracting activities through NIHR Central Portfolio Management System (CPMS) and interactive Costing Tool (iCT), within delegated company representative access. Coordinate required service requests, accurate study identifiers and contacts, and corrections with authorised record owners.
• With Budgets and Payments and study teams, quality-check protocol-based iCT resource requirements and coordinate National Contract Value Review (NCVR) submissions, lead-site queries and national sign-off tracking. Use current national escalation pathways rather than routine site-by-site renegotiation of nationally agreed resources or prices.
• Ensure contracts include the approved iCT site-sp