Job Description Summary

This position will be responsible for the creation, negotiation and execution of clinical contracts for US and OUS studies.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Main Purpose of the Position

This position will support the preparation of clinical study agreements (“CSAs”) and other types of agreements for Becton, Dickinson and Company (“BD”) to facilitate research and clinical trial activities. This individual will work with other associates in the CoPat (Contracts, Payments and Transparency) group and will be responsible for the following activities:

• Liaises directly with the BD Law Group attorneys to develop and implement contracting templates.

• Works with the Clinical Project Managers to develop Clinical Trial Agreements based on approved BD templates.

• Serves as "first line" negotiator with external parties regarding requested changes to proposed agreements; consults with the Law Group) to develop responses for issues not within CoPat’s negotiation guidelines.

• Works with Clinical Project Managers and Law Group or other members of the CoPaT group to resolve any issues and facilitate agreement with the Investigators/sites, assisting in negotiations, and handling the execution process.

• Assumes ownership of the agreement they are responsible for, leading the site changes and updates which may include translations of revisions to bi-lingual templates when sites are located outside of the United States.

• Responsible for incorporating the accurate Data Protection Agreements (DPAs) and Standard Contractual Clauses (SCCs) into agreements with European sites when vital to ensure compliance with General Data Protection Regulations (GDPR).

• Works with the Law Group Center of Excellence (COE) to prepare and negotiate Master Service Agreements, Consulting Agreements, software agreements to support activities with consultants, contractors, vendors, KOLs, Advisory Boards, service providers, and external grant recipients.

• Ensures contracts and agreements are based on approved BD templates, working with the Law Group or other members of the CoPat group to resolve any issues and facilitate agreement with the external party, participating in negotiations, executing the process of execution, and ensuring appropriate copies and records are maintained for the agreements.

• Review clinical budgets and incorporate them into CSA.  Prepare payment schedule.

• Ensure information for new sites/vendors are provided payment specialists for onboarding.

                                                                                               

Primary Responsibilities and Duties

• Facilitate the creation, negotiation and execution of clinical contracts with potential sites and other parties and ensure compliance with BD standards and expectations.
• Follows up directly with appropriate collaborators to address any open contract items, including but not limited to the BD Privacy office to address any GDPR contract related items.  
• Incorporates budgets into the Agreements and crafts payment schedules as vital while ensuring compliance with BD payment terms.
• Serve as primary contact with the law group, study teams, sites, procurement and external parties to ensure use of approved templates, and to facilitate the execution of vita CDA and contract documents with potential sites and other parties, and ensure compliance with standards and expectations.
• Facilitate ongoing meetings with study managers to track the status of contracts and provide updates as vital.
• Provide completed documents for TMF, Legal and other parties as applicable. Track contract status and maintain files. Handle approved templates.
• May perform other duties as required

 

Education and Experience

• Bachelor's degree or higher preferred with concentration in the life sciences or other relevant technical area, such as clinical trials, regulatory affairs, or legal clinical trial contracting.  
• Paralegal Certification may be desirable.           
• At least 4 years