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Senior Contract Associate

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

đź’µ ÂŁ52k - ÂŁ65k / year

⏰ Full Time

đźź  Senior

Where this job comes from

Posted on BeOne Medicines's careers page, not through a job board

First seen by Remote Rocketship 0 minutes ago

Logo of BeOne Medicines

BeOne Medicines

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

đź’Š Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

đź“‹ Description

• Draft, negotiate and finalize complex clinical site contracts, ancillary agreements and amendments for company-sponsored clinical trials throughout the study lifecycle • Execute contracts against planned timelines and targets • Manage contract budget grids and ensure cost calculations align with protocols and site agreements • Perform quality checks on final approved contract and budget documents and initiate signature processes • Ensure contracts meet agreed timelines, Fair Market Value requirements, legal requirements and regulatory requirements • Serve as primary point of contact between Clinical Business Operations, Global Clinical Operations, Legal, investigator sites and external service providers • Collect and maintain country and site intelligence and prepare site-specific contract process flows • Forecast, track and communicate planned fully executed contract dates, risks and changes • Liaise with Contract Managers and Legal on contract templates and Legal Playbook updates • Coordinate with Clinical Site Budgets and Payments to ensure investigator site budgets and contracts are approved and executed according to policy • Communicate legal and budgetary issues and escalate contracting problems or potential delays • Perform legal translation of contract language for sites as needed • Maintain communications, progress tracking, CBO trackers, contract filing, distribution and Contract Management System records • Prepare amendments, notes to file and related contract documents • Attend investigator site, project, CBO and other meetings • Provide handoff to project/payment teams after execution of final site documents • Coordinate UK costing and contracting activities through NIHR CPMS and the interactive Costing Tool (iCT) • Coordinate service requests, study identifiers, contacts and corrections with authorized record owners • Quality-check protocol-based iCT resource requirements and coordinate NCVR submissions, lead-site queries and national sign-off tracking • Ensure contracts contain approved iCT site-specific financial appendices and payment arrangements • Reconcile protocol/costing versions, legal entities and schedules, and coordinate revised costing approvals and amendments • Prepare applicable UK model agreements, including mCTA or CRO-mCTA, and escalate deviations or side agreements for formal waiver • Liaise with NHS/HSC R&D and contracting teams, NIHR and devolved-nation contacts • Maintain costing/contract audit trails, reconcile CPMS/iCT data with CMS/CTMS and hand over payment terms • Distinguish contract execution from regulatory approval and sponsor green light; study-record ownership and recruitment reporting remain with designated teams unless delegated

🎯 Requirements

• Bachelor's degree with 3 or more years of contract/budget experience, with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor; alternatively, up to four years in clinical operations, preferably within the biotechnology, pharmaceutical, and/or CRO industry • Microsoft Office apps, CTMS, Contract Lifecycle Management System, Veeva, Jira, SharePoint and similar tools • 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 CPMS/iCT records with internal contract and study-management systems • Good knowledge of ICH-GCP, pharmaceutical-related regulations and laws • Good understanding of clinical trial contracting processes and relevant clinical operations practices • Awareness and understanding of compliance and regulatory matters in clinical research • Proven negotiation, interpersonal and business skills • Strong planning and organizational skills; 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 • In-depth knowledge of the UK clinical trial contracting market and local contracting practices • Experience in financial, budget, cost management/analysis, accounting and/or financial planning is desirable • Knowledge of intellectual property, publication, indemnification and other standard site-contract issues in clinical research • Demonstrated ability to work effectively at all organizational levels • Demonstrated experience supporting UK commercial clinical trial contracts with NHS/HSC organisations • Working knowledge of NCVR, protocol-based iCT costing, national review/sign-off requirements and current unmodified UK model agreements • Ability to distinguish national costing requirements from permitted site-specific completion and identify and escalate exceptions • Working knowledge of UK research governance and contracting interfaces, including HRA/HCRW requirements, 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 • Ability to keep CPMS/iCT and NCVR training current as national processes evolve • Willingness to work in a fast-paced environment with time-sensitive material

🏖️ Benefits

• Equal opportunity employment • Travel opportunity/requirement of 10%

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