Senior Contract Associate

BeOne Medicines Poland sp. z o.o.; Poland; On-site; PLN 234,000 - 293,000; Full time

Job summary

BeOne Medicines Poland sp. z o.o. is seeking an experienced contracts professional to manage clinical trial agreements and budget components with sites and internal stakeholders. You will steer the contract lifecycle, ensure FMV compliance, and maintain CMS records in a fast-paced biotech environment.

The role requires Polish law knowledge, fluent English, and strong negotiation and planning skills. Occasional travel up to 10% is expected, with a focus on timely, compliant contracting.

Qualifications

• Bachelor's degree in a relevant field with evidence of increasing responsibility within pharmaceutical contracting or related field.
• Up to four years in clinical operations or CRO/pharma environment is desirable.

Responsibilities

• Prepare, negotiate, and finalize clinical trial agreements and amendments with sites.
• Ensure contracts meet planned timelines and target dates.
• Manage budget grid and ensure cost calculations align with protocol and site.
• Maintain records management for contract documents and perform QC of final documents.
• Lead signature process and ensure delivery within FMV and regulatory requirements.
• Liaise with CM, Legal, GCO, and Investigator Sites across jurisdictions.
• Track country/site intelligence and develop contract process flows as needed.

Skills

Negotiation

Budget management

Contract management

Polish language

English language

Interpersonal skills

Education

Bachelor's degree in a relevant field

Tools

Microsoft Office

CTMS

Contract Lifecycle Management System

Veeva

Jira

SharePoint

Job description

General 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.

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

Supervisory Responsibilities

• None

Computer Skills

• Microsoft Office apps, CTMS, Contract Lifecycle Management System, Veeva, Jira, Sharepoint etc.

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 or


• Up to four (4) years in clinical operations, preferably within the biotechnology, pharmaceutical, and/or CRO industry.

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 Polish is required, together with strong written and verbal communication skills in English. In-depth knowledge of the Polish 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.

Travel

Yes, 10%

Salary Range Poland: 234,000.00 PLN - 292,500.00 PLN

Global Competencies

• Fosters Teamwork


• Provides and Solicits Honest and Actionable Feedback


• Self-Awareness


• Acts Inclusively


• Demonstrates Initiative


• Entrepreneurial Mindset


• Continuous Learning


• Embraces Change


• Results-Oriented


• Analytical Thinking/Data Analysis


• Financial Excellence


• Communicates with Clarity

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.