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.
General 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. The contracting activity supported by the CBO team is fast-paced, with short deadlines and quick turnaround times therefore Contract Associate must be capable of managing priorities effectively, proactively communicating issues and working in a fast-paced environment.
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 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;
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 BeiGene policies;
Provides a handoff to the project/payment
Salary Range Poland: 234,000.00 PLN - 292,500.00 PLN
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
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.