Senior Contract Associate page is loaded
Senior Contract Associate
Apply locations: Brazil Remote
Time type: Full time
Posted on: Posted Yesterday
Time left to apply: End Date: April 15, 2025 (2 days left to apply)
Job requisition id: R28779
BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. 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 all aspects of preparation, negotiation, and execution of required site/investigator contracts.
The Senior Contract Associate assumes responsibility for quality deliverables throughout the conduct of the study with a concentration on site/investigator contracts during Site Start Up and up to Site initiation.
The contracting activity supported by the CBO team is fast-paced, with short deadlines and quick turnaround times; therefore, you must be capable of managing priorities effectively, proactively communicate issues, and work in a fast-paced environment.
The Senior Contracts Associate will be responsible for the development, dissemination, negotiation, and finalization of clinical site/investigator contracts including investigator grants between BeiGene and clinical research sites. The Senior Contracts Associate will operate as a study contracts lead at the Protocol level to ensure site contracts are completed in accordance with Study timelines and handle direct negotiations of clinical contracts.
Essential Functions:
- Serve as the primary contact between CBO and Global Clinical Operations, Legal, Sites, and/or external service providers in accordance with the study-related activities to meet the business objectives.
- Serves as the primary site contracts lead person at the Protocol level, as assigned.
- Prepares and documents process flows for each study.
- Drafts, reviews, and analyzes site and investigator contracts.
- Negotiates and finalizes clinical trial contracts and services contracts with BeiGene Legal Department, study team, investigators, and/or clinical sites, amending and terminating such contracts as needed.
- Manages execution (including signature process) of contracts with sites, investigators, and other project-related contracts as applicable.
- Actively plans and forecasts fully execution planned dates of site contracts and effectively communicates with the Clinical and Study Start-up team(s) on such projections.
- Liaises with legal to review and update contract template(s) as needed, including MCTA/CTA/PA or any ancillary agreement template(s).
- Liaises with legal to review and contribute updates to the legal Playbook guidance document, as needed.
- Liaises with Investigator Payments team to ensure site contracts including investigator grants are executed in accordance with BeiGene payment guidelines.
- Ensures all investigator contracts are reviewed and approved by legal or delegate prior to execution.
- Revises legal contracting text using BeiGene Playbook process and escalates any revisions in accordance with CBO and Legal guidelines.
- Communicates and explains legal and budgetary issues to internal and external parties per department guidelines.
- Performs legal translation and/or proofreading of contracts with clinical sites/investigators.
- Maintains active/frequent communication with external partners and/or investigators and internal departments regarding clinical contracts throughout the contract lifecycle.
- Assists in developing investigator baseline budgets, as needed/required.
- Prepares subsequent contract amendments, notes to files, and other related contract activities, as needed.
- Escalates issues to internal and external stakeholders as necessary.
- Participates in project-related meetings.
- Develops and manages status trackers, prepares startup and close-out documentation, and maintains Contract Management system records.
- Provides a handoff to the project/payment team upon execution of a site’s final contractual documents.
- Takes and distributes agendas and minutes, as appropriate.
- Collects site-specific contract/budget information and contributes to the maintenance of contract/budget intelligence tools.
- Assists with the training of new ICM team members on CBO Processes and systems, as needed.
- Assists ICM management in development and implementation of new initiatives and negotiation/execution processes.
- Provides training on clinical site contractual requirements and negotiation.
- Mentors and trains junior-level staff.
Minimum Requirements – Education and Experience:
BS with 3 years’ experience or up to 5 years in clinical operations preferably within the biotechnology, pharmaceutical, CRO, industry.
Other Qualifications:
- Prior site budget development and/or negotiations, global is preferred.
- Ability to negotiate basic and moderate investigator contract and payment terms.
- Collaborate with Clinical Research Organizations.
- Flexibility to assume a workload which frequently necessitates an adjustment of priorities.
- Goal and task-oriented, self-starter with proven ability to work independently.
- Able to proactively identify issues and provide potential solutions for resolution.
- Detail-oriented.
- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
- Proficiency with Medidata-Grant Manager and all applications of Microsoft Office.
- Good interpersonal skills.
- Comfort with ambiguity; ability to act without having the total picture.
- Performs other administrative duties as assigned.
- Strong interpersonal skills and professional attitude are essential as this individual interacts with many people of varying levels of responsibility for clinical studies and business performance.
Supervisory Responsibilities: N/A
Travel: N/A
Computer Skills: Proficiency in the Microsoft Office Suite: Outlook, Word, Excel, SharePoint, OneNote, and Grants Manager or similar system.
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.
- 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 and we value diversity. 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.