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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
**Job Function: **
R&D Operations
**Job Sub Function: **
Clinical Trial Project Management
Job Category:
Professional
All Job Posting Locations:
Neuss, North Rhine-Westphalia, Germany
Job Description:
**About Innovative Medicine **
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Global Clinical Operations (GCO)
Johnson & Johnson is currently seeking a Senior Site Contract Manager (CCS) to join our team located in Germany.
In this role 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
Principal Relationships:
This position reports to Manager, Site Contracting.
Internal: ▪ Internal Business Partners (CCS, TA, MAF, MAO, GD, HCC, Risk Management, Legal, etc.) outside parties
External: ▪ Clinical Investigator Sites ▪ Commercial Suppliers ▪ Clinical Research Organizations (when applicable).
**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
- Demonstrated AI literacy and an AI enabled mindset, including the ability to apply AI tools responsibly in daily work to improve productivity, decision making and quality of outcomes.
- 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. Other:
- Fluency in and German and English is required.
- Travel Percentage: 10%
#LI-ŠJ1, #LI-Remote
**Required Skills: **
Preferred Skills:
Business Behavior, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Give Feedback, Laboratory Operations, Medical Knowledge, Mentorship, Problem Solving, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics
The anticipated base pay range for this position is:
€62,500.00 - €97,865.00
Benefits:
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.