Sr. Site Contract Manager
il y a 6 jours
**bout us**:
The Janssen Campus in Belgium is a major innovation hub and is part of the pharmaceutical companies of Johnson & Johnson. It brings together a unique mix of expertise, skills, and partnerships in research and development (R&D), manufacturing, and the launch of new drugs. We are working together to create a future where disease is a thing of the past.
**Key Responsibilities**:
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.
- 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 oversight of a Clinical Research Organization responsible for contract negotiations.
- Responsible for delivery of established targets/measurements. Responsible for analyzing contract requests/needs from operating companies and translating them 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 processes, 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 the adequate scope of work, the 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 a vision to drive solutions
**Principal Relationships**:
**Internal**:
- Internal Business Partners such as Contract and Compliance Service (CCS), Therapeutic Area (TO), Medical Affairs (MAF), Global Clinical Development Organisation (GCDO), Janssen Research Procurement (JRP), Health Care Compliance (HCC), Risk Management and Legal
**External**:
- Clinical Investigator Sites
- Commercial Suppliers
- Clinical Research Organizations (when applicable).
**Qualifications**:
**Experience, skills & proficiencies required**:
- Proven experience 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 several years of negotiation and contract experience
- 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 QA 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?**
**What we’re about**:
- Committed to caring
- Responsible to our communities
- 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 based on disability.
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