[Hiring] Senior Contract Associate @BeiGene

Role 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, and 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.

• 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 calculations 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 BeiGene 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 BeiGene legal to contribute updates to the BeiGene Legal Playbook guidance document as needed.
• Liaise with Investigator Payment Management (IPM) team to ensure site contracts, including investigator site budgets, are approved and executed in accordance with CBO guidelines and BeiGene policies.
• Ensure all investigator contracts are reviewed and approved by legal and/or delegate prior to execution, and in accordance with CBO and BeiGene 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 BeiGene 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.
• Escalate 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 BeiGene policies.
• Provide a handoff to the project/payment team upon execution of a site’s final contractual documents.

Qualifications

• Bachelor's degree with 3 or more years clinical research site contracting and budgeting 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.

Requirements

• Experience with Clinical Trial Agreements, budgeting, and fair market value principles.
• 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.
• Strong written and verbal communication including written and verbal fluency in English and local language (if not English) and interpersonal skills, including conflict resolution and problem solving.
• 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.
• 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.

Benefits

• Salary Range Germany: 69,800.00 EUR - 87,200.00 EUR
• Travel: Yes, 10%

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.