Senior Contract Associate

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

📋 Description

• Draft, negotiate, and finalize intricate clinical site contracts, ancillary agreements, amendments, and associated documents throughout the clinical trial lifecycle.

• Implement contracts according to established timelines and objectives.

• Oversee contract budget grids and ensure that cost calculations are consistent with the protocol and site agreements.

• Conduct quality checks on approved contracts and budget documents, initiating the signature processes.

• Ensure all contracts adhere to Fair Market Value, legal, regulatory, CBO, and BeOne Medicines standards.

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

• Gather and maintain intelligence on countries and sites, preparing site-specific contract process flows.

• Anticipate, monitor, and communicate contract execution dates, risks, and delays.

• Review and revise contract templates, contributing to updates of the legal playbook.

• Collaborate with Clinical Site Budgets and Payment teams to ensure contracts and investigator budgets are approved and executed.

• Address legal and budgetary concerns with internal and external stakeholders.

• Provide legal translations of contract language for sites when necessary.

• Maintain communication with site personnel and internal partners throughout the contract lifecycle.

• Participate in investigator site, project-related, CBO, and other meetings.

• Manage CBO trackers, filing, distribution of contract documents, and records in the Contract Management System.

• Provide handoff to the project/payment team after the final site documents are executed.

⛳️ Requirements

• Bachelor's degree with 3 or more years of contract/budget experience, progressively increasing responsibility in a pharmaceutical company, CRO, or relevant industry vendor; or up to four years in clinical operations.

• Preferred background in legal or administrative management education.

• Solid understanding of ICH-GCP and pharmaceutical-related regulations and laws.

• Familiarity with clinical trial contracting processes and clinical operations practices.

• Awareness of compliance and regulatory issues in clinical research.

• Demonstrated negotiation, interpersonal, and business skills.

• Strong planning and organizational capabilities; adept at working independently in a dynamic environment with competing priorities.

• Proven record of meeting deadlines and objectives.

• Native-level proficiency in written and spoken Polish is required.

• Strong written and verbal communication skills in English.

• Extensive knowledge of the Polish clinical trial contracting market and local contracting practices.

• Experience with Microsoft Office applications, CTMS, Contract Lifecycle Management Systems, Veeva, Jira, and SharePoint.

• Desirable experience in financial management, budget analysis, accounting, and/or financial planning.

• Understanding of intellectual property, publication, indemnification, and other standard site-contract issues in clinical research.

• Capability to work with fast-paced, time-sensitive materials and at all organizational levels.

• Willingness to travel up to 10%.

🏝️ Benefits

• Travel: Yes, 10%.

• Equal opportunity employment.