Clinical Contracts Specialist
Job Description SummaryThis position will be responsible for the creation, negotiation and execution of clinical contracts for US and OUS studies.
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 andDuties
- 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 of work in handling research or clinical trial contracts for sponsors.
- Integrates active listening, collaboration, and a positive image in pursuit of team goals.
- Must be a highly motivated self-starter with attention to detail and the ability to multi task and prioritize.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work LocationUSA NJ - Franklin Lakes
Additional LocationsUSA MD - Sparks - 7 Loveton Circle
Recommendto a friend
"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ