Clinical Contracts Specialist (m/f/i)
Job Description Summary
Job Description
This position will support preparation of confidential disclosure agreements, clinical trial contracts, research contracts and other types of contracts for Becton, Dickinson and Company 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 one or more of the following activities:
Liaises directly with the BD Law Group attorneys to develop and implement contracting templates.
Serves as "first line" negotiator with external parties regarding requested changes to proposed agreements; consults with the Law Group and Outside Counsel (as directed) to develop responses for issues not within CoPat’s negotiation guidelines.
Use BD’s contract management database to generate and negotiate Confidential Disclosure Agreements with external parties on behalf of BD. Manage the process of execution and ensure appropriate copies and records are maintained for the agreements.
Works with the R&D and clinical trial teams to develop Clinical Trial Agreements based on approved BD templates, working with the clinical trial teams and Law Group or other members of the CoPaT group to resolve any issues and facilitate agreement with the Investigators/sites, assisting in negotiations, managing the process of execution, and ensuring appropriate copies and records are maintained for the agreements.
Develop required contracts for implementation of Master Service Agreements, Research Agreements, Consulting Agreements, software agreements, KOL agreements, testing agreements, and Instrument Service 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, managing the process of execution, and ensuring appropriate copies and records are maintained for the agreements.
Primary Responsibilities andDuties
Liaise with and support Divisional & Corporate Clinical Affairs and Legal Department attorneys with CA-related Agreements; must work well both with a team and independently under limited supervision, exercising discretion, poise, professionalism, maturing and ethical integrity
Facilitate the execution of necessary CDA and contract documents with potential sites and other parties and ensure compliance with BD standards and expectations.
Provide executed documents for TMF, Legal and other parties as applicable. Track contract status and maintain files. Manage approved templates.
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 necessary CDA and contract documents with potential sites and other parties, and ensure compliance with BO standards and expectations.
May perform other duties as required
Education and Experience
Bachelor 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.
Prior experience with a Contract Tracking Database, or Clinical Trial Management System
At least 4 years work in managing research or clinical trial contracts.
Integrates active listening, teamwork, and a positive image in pursuit of team goals.
Our Offer
A professional challenge in a highly motivated team, a global environment and with long-term perspectives. A familiar working atmosphere in an innovative environment where your opinion matters. Diversity characterizes our corporate culture and we are convinced that it makes us a stronger team. We value each person as an individual with their abilities and needs. In this sense, we welcome applicants who wish to work part-time, people with severe disabilities and applicants of any gender.
Primary Work Location
GBR Winnersh - Eskdale RoadAdditional Locations
DEU Heidelberg - Tullastrasse, NLD Drachten - MarconilaanWork Shift
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