Senior Contract Associate

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-specific financial appendix and payment arrangements; reconcile protocol/costing versions, site legal entities and schedules, and coordinate revised costing approvals and contract amendments when required.
• Prepare the current applicable UK model agreement, including mCTA or CRO-mCTA, without modification except as permitted by its guidance.
• Complete study/site particulars and elevate deviations or side agreements to the Contract Manager and Legal for any required formal waiver.
• Liaise with NHS/HSC R&D and contracting teams, NIHR and devolved-nation contacts to resolve dependencies.
• Maintain costing/contract audit trails, reconcile assigned CPMS/iCT data with CMS/CTMS, and hand over payment terms.
• Distinguish execution from regulatory approval and sponsor green light; study-record ownership and recruitment reporting remain with designated teams unless expressly delegated.

Education Required

• Bachelor's degree with 3 or more years of contract/budget experience (legal or administrative management education background preferred) with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor.
• Up to four (4) years in clinical operations, preferably within the biotechnology, pharmaceutical, and/or CRO industry.

Computer Skills

• Microsoft Office apps, CTMS, Contract Lifecycle Management System, Veeva, Jira, Sharepoint etc.
• Practical proficiency in NIHR CPMS and the UK interactive Costing Tool (iCT), including authorised company representative access, submission tracking, costing version control and retrieval of site-specific financial appendices; ability to reconcile these records with internal contract and study-management systems.

Other Qualifications

• 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.
• Native-level written and verbal proficiency in English is required, together with strong written and verbal communication skills in English.
• In-depth knowledge of the UK clinical trial contracting market, including local contracting practices, is also required.
• 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.
• Demonstrated experience supporting UK commercial clinical trial contracts with NHS/HSC organisations, with working knowledge of NCVR, protocol-based iCT costing, national review/sign-off requirements and the appropriate use of current unmodified UK model agreements.
• Ability to distinguish national costing requirements from permitted site-specific completion and to identify and expedite exceptions.
• Working knowledge of UK research governance and contracting interfaces, including HRA/HCRW requirements and relevant arrangements in Scotland and Northern Ireland, UK data protection requirements and NHS/HSC institutional sign-off.
• Strong attention to protocol-to-budget consistency, document quality and audit trails; ability to coordinate across Contracts, Budgets and Payments, Legal and study teams, and keep CPMS/iCT and NCVR training current as national processes evolve.

Travel

Yes, 10%

Salary Range UK: 52,000.00 GBP - 65,000.00 GBP

Equal Opportunity

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

About BeOne

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents.