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Senior Site Contract Manager

Breda, Netherlands; Beerse, Belgium

Description

Johnson & Johnson is currently seeking a Senior Site Contract Manager to join our team located in Beerse, Belgium or Breda, Netherlands.

You will be 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. You will provide support to the clinical team in the pricing, planning, execution and control of grants and contracts.

Principal Responsibilities:
• 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 targets/measurements. Responsible for analyzing contract requests/needs from operating companies and translating into appropriate contracts/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

Qualifications

Education and Experience Requirements:
• 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
• Previous experience working in virtual teams preferred.

DECISION-MAKING AND PROBLEM-SOLVING:
• Adhere to SOPs, ethics and departmental compliance as determined by GD management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with CCS, GD and operating companies. Comply with requests from QA and auditors.
• Able to work independently as well as in a collaborative team environment.

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Blijf op de hoogte van de laatste farma vacatures

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Blijf op de hoogte van de laatste farma vacatures