Senior Contract Associate

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Draft, negotiate, and finalize intricate clinical site contracts, ancillary agreements, and amendments for company-sponsored clinical trials across the study lifecycle.

• Execute contracts in alignment with planned timelines and targets.

• Manage contract budget grids and ensure cost calculations are consistent with protocols and site agreements.

• Conduct quality checks on final approved contracts and budget documents, and initiate signature processes.

• Ensure contracts adhere to agreed timelines, Fair Market Value standards, legal obligations, and regulatory requirements.

• Act as the primary liaison between Clinical Business Operations, Global Clinical Operations, Legal, investigator sites, and external service providers.

• Gather and maintain country and site intelligence, and prepare site-specific contract process flows.

• Forecast, monitor, and communicate planned fully executed contract dates, risks, and changes.

• Collaborate with Contract Managers and Legal on contract templates and updates to the Legal Playbook.

• Coordinate with Clinical Site Budgets and Payments to ensure that investigator site budgets and contracts are approved and executed per policy.

• Communicate legal and budgetary issues and escalate contracting challenges or potential delays.

• Perform legal translation of contract language for sites as required.

• Maintain communication, progress tracking, CBO trackers, contract filing, distribution, and records in the Contract Management System.

• Prepare amendments, notes to file, and related contract documents.

• Attend meetings with investigator sites, projects, CBO, and others as necessary.

• Provide handoff to project/payment teams following the execution of final site documents.

• Coordinate UK costing and contracting activities through NIHR CPMS and the interactive Costing Tool (iCT).

• Manage service requests, study identifiers, contacts, and corrections with authorized record owners.

• Perform quality checks on protocol-based iCT resource requirements and coordinate NCVR submissions, lead-site queries, and national sign-off tracking.

• Ensure contracts include approved iCT site-specific financial appendices and payment arrangements.

• Reconcile protocol/costing versions, legal entities, and schedules, and manage 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 contacts from devolved nations.

• Maintain costing/contract audit trails, reconcile CPMS/iCT data with CMS/CTMS, and hand over payment terms.

• Differentiate between contract execution and regulatory approval; ensure study-record ownership and recruitment reporting stay with designated teams unless delegated.

⛳️ Requirements

• Bachelor's degree with 3 or more years of contract/budget experience, demonstrating 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.

• Proficiency in Microsoft Office applications, CTMS, Contract Lifecycle Management Systems, Veeva, Jira, SharePoint, and similar tools.

• Practical proficiency with NIHR CPMS and the UK interactive Costing Tool (iCT), including authorized 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.

• Solid knowledge of ICH-GCP, pharmaceutical regulations, and laws.

• Good understanding of clinical trial contracting processes and relevant clinical operations practices.

• Awareness and comprehension 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; a track record of meeting deadlines and objectives.

• 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 organizations.

• 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.

• Familiarity with 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 ensuring consistency between protocol and budget, document quality, and audit trails.

• Capability 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 thrive in a fast-paced environment with time-sensitive material.

🏝️ Benefits

• Equal opportunity employment.

• Travel opportunity/requirement of 10%.