Senior Site Contract Manager
Senior Site Contract Manager
Contract: full time
Janssen Research & Development Global Clinical Operations Contracts and Compliance Service Department is recruiting for a Senior Site Contracting Manager, located in Europe, Middle East or Africa (EMEA).
Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. Provide support to the clinical team in the pricing, planning, execution and control of grants and contracts.
The responsibilities & the impact YOU will have:
· Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations.
· Responsible for delivery on established contracting targets and measurements. Responsible for analyzing contract requests and needs from operating companies and translating into appropriate contracts and budgets for company sponsored and investigator initiated clinical trial agreements and other relevant legal documents as they relate to various clinical projects. Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.
· Provide specialized support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
· Analyze investigator grants for fair market value aligned with regional knowledge and the J&J grant pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information. Participate in and/or lead the approval escalation of grants as appropriate.
· Work with the global CCS team as necessary to review and analyze contractual terms and conditions in order to reach acceptable language. Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions and communicate such to stakeholders. Liaise with CCS management and functional CCS support teams, legal, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.
· Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites. Mentor and train new contract coordinators and analysts.
· Assume responsibility for all aspects of legal document and metrics tracking. Determine potential needs for contract amendments and manage amendment lifecycle.
· Exemplary customer focus with vision to drive solutions
· This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.
We would love to hear from YOU, if you have:
· Bachelor’s degree in appropriate scientific or business disciplines
· 3 to 5 years-experience and/or equivalent competencies in pharmaceutical industry/clinical research
· Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) a plus
· Must have a working knowledge of the clinical development process with two (2) years of negotiation and contract experience
· Familiarity with clinical research processes
· Ability to work effectively in cross function teams
· Strong and proven negotiation and problem resolution skills
· Working knowledge of PCs (MS Office suite at a minimum) and database management
· Must demonstrate innovative spirit, have strong interpersonal skills, and ability to manage a high volume of work
· [INSERT 5-7 bulleted required qualifications.
· Include experience/skills/competencies and any physical requirements (e.g. lifting 50lbs/kg, etc.), where applicable.]
· Previous experience working in virtual teams' environment preferred.
· Experience with coordination and overseeing project work of Contract Research Organization
This is what awaits YOU at J&J:
· An opportunity to be part of a global market leader.
· A dynamic and inspiring working environment.
· Many opportunities to work on challenging projects and assignments.
· Possibilities for further personal as well as professional development.
· Many employee benefits.
Employee benefits are regulated by an internal policy that contains full details regarding the entitlement and conditions for the benefits.
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