Senior Site Contract Manager
Location
High Wycombe, Buckinghamshire | United Kingdom
Job description
Senior Site Contract Manager
In Janssen UK we have an ambitious vision to integrate digital into the core of how we work amplifying our core capabilities and making a positive difference to the lives of patients, healthcare professionals, our employees and our communities. We have an exciting opportunity for a
Senior Site Contract Manager, located in High Wycombe, UK, to join our team.
Remote work options may be considered on a case-by-case basis and if approved by the company.
Are you ready to join our team? Then please read further!
Role Summary:
- 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.
Role & 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 following 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 process of grants as appropriate.
- Work with the global CCS team to review and analyze 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 partners. Liaise with CCS management and functional CCS support teams, legal, Healthcare Compliance, Risk Management, Privacy, and other partners to acquire guidance and raise issues as appropriate.
- Work proactively to improve processes and establish refinements that reduce cycle time, build 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. Resolve potential needs for contract amendments and lead amendment lifecycle.
- Outstanding customer focus with vision to drive solutions
Principal Relationships: - Internal Business Partners such as Contract and Compliance Service (CCS), Therapeutic Area (TA), Medical Affairs (MAF), Global Clinical Development Organisation (GCDO), Janssen Research & Development Procurement (JRP), Health Care Compliance (HCC), Risk Management and Legal
- External: Clinical Investigator Sites, Commercial Suppliers, Clinical Research Organizations (when applicable).
Experience, skills & proficiencies required: - Bachelor's degree in appropriate scientific or business subject areas
- Proven experience (3-5 years ideally) and/or equivalent competencies in the pharmaceutical industry/clinical research
- Familiarity with healthcare compliance such as Health Insurance Portability and Accountability Act (HIPAA), Foreign Corrupt Practices Act (FCPA) or Safe Harbor to name a few would be advantageous
- Proven solid understanding of the clinical development process with
- Familiarity with healthcare compliance such as Health Insurance Portability and Accountability Act (HIPAA), Foreign Corrupt Practices Act (FCPA) or Safe Harbor to name a few would be advantageous
- Familiarity with healthcare compliance such as Health Insurance Portability and Accountability Act (HIPAA), Foreign Corrupt Practices Act (FCPA) or Safe Harbor to name a few would be advantageous
- Familiarity with clinical research processes
- Ability to work effectively in a variety of teams
- Strong and proven negotiation and problem resolution skills Decision Making & Problem Solving
- Adhere to SOPs, ethics and departmental compliance as determined by GCDO management as well as operating companies, corporate, HCC and Quality Assurance guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with CCS, GCDO and operating companies.
- Able to work independently as well as in a collaborative team environment.
What type of mark will YOU make? By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our dedication to be the world's healthiest workforce you can strengthen your body as well and your mind. When you work with us you can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there's no end to the lasting impact we can make together. And that changes everything.
What's in it for YOU? It's vital to us that you feel you can bring your whole self to work; at J&J we provide an environment for you to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive wage and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life. Examples of this include: online Digital GP, private healthcare, Retail Vouchers, Discounted & Subsidised Gym memberships and you can get to support community projects as part of our global Corporate Social Responsibility programme.
What we're about: We are passionate about our work and play vital roles across a range of professional subject areas, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we're each
- Committed to caring
- Responsible to our communities
- Ready to apply our knowledge and know-how
- Unique in our background and experiences
- The drivers of our own success
- Passionate about doing what's right
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified individuals will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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