Contract Associate

Remote: 
Full Remote
Contract: 
Work from: 

Offer summary

Qualifications:

Bachelor's degree in a relevant field or equivalent experience., Strong knowledge of ICH-GCP and clinical trial contracting processes., Proven negotiation and interpersonal skills with a focus on compliance and regulatory matters., Fluency in English and local language, with strong written and verbal communication skills..

Key responsibilities:

  • Draft, negotiate, and finalize Clinical Site Contracts related to clinical trials.
  • Serve as the primary point of contact between Clinical Business Operations and external stakeholders.
  • Ensure timely delivery of contracts while maintaining compliance with legal and regulatory requirements.
  • Maintain communication with site personnel and track contract progress throughout the lifecycle.

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BeiGene XLarge http://www.beigene.com
10001 Employees
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Job description

About us

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).

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.

Job Description:

General Description:

The Contract Associate is responsible for drafting, negotiating, and finalizing 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.  This role is also referred to as Site Negotiator and/or Contract Analyst and may be handled by Study Startup team members in some cases, where expressly delegated to do so.

  

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: 

  • Draft, review, analyze and negotiate Investigator Site Contracts and budgets, and any other Site related agreements, and escalates to CM, Clinical Study Manager (CSM) and/or legal as needed; 
  • 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 team upon execution of a site’s final contractual documents
  • Performs other duties as assigned by management.

Supervisory Responsibilities:   

          none

Qualification Required:

Computer Skills:  

  • Microsoft Office apps, CTMS, Contract Lifecycle Management System,  Veeva, Beep/Sharepoint

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. 
  • 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
  • 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%

What We Offer To Our Valued Employees

  • Market competitive compensation package including performance-based annual bonus scheme
  • Company shares (generous welcome grant and performance-based annual equity plan!)
  • In-house and external learning and development opportunities
  • Fantastic benefits program and keep improving!
  • Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
  • Join us and Make momentum in your career!

BeOne Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

  • 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

BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://www.beigene.com/privacy-policy).

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Microsoft Office
  • Negotiation
  • Organizational Skills
  • Social Skills
  • Problem Solving
  • Adaptability
  • Time Management
  • Teamwork
  • Communication

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