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 on 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 pace 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 provider 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 document process flows for each study
Drafting, reviewing, and analyzing site, investigator contracts
Negotiate and finalize and/or assistance in negotiation and finalization of clinical trial contracts and services contracts with BeiGene Legal Department, study team, investigators and/or clinical sites, amending and terminating such contracts as needed
Manage execution (including signature process) of contracts with sites, investigators and other project-related contracts as applicable
Actively plans and forecast fully execution planned dates of site contracts and effectively communicates with the Clinical and Study Start up team(s) on such projections
Liaise with legal to review and update contract template(s) as needed, including MCTA/CTA/PA or any ancillary agreement template(s);
Liaise with legal to review and contribute updates to the legal Playbook guidance document, as needed
Liaise with Investigator Payments team to ensure site contracts including investigator grants are executed in accordance with BeiGene payment guidelines
Ensure 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
Maintain active/frequent communication with external partners and/or investigators and internal departments regarding clinical contracts throughout the contract lifecycle
Assist in developing investigator baseline budgets, as needed/required
Prepare subsequent contract amendments, note to files and other related contract activities, as needed
Escalates issues to internal and external stakeholders as necessary
Participates in project-related meetings
Develop and manage status trackers, prepare startup and close-out documentation and maintain Contract Management system records
Provides a handoff to the project/payment team upon execution of a site’s final contractual documents
Take and distribute agendas and minutes, as appropriate
Collect site specific contract/budget information and contribute to the maintenance of contract/budget intelligence tools.
Assist with the training of new ICM team members on CBO Processes and systems, as needed
Assist 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
Perform 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.
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.