Randomization & Trial Supply Management (RTSM) Lead - #138537

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

Job Function

R&D Operations

Job Sub Function

Clinical Supply Operations

Job Category

Professional

All Job Posting Locations:

High Wycombe, Buckinghamshire, United Kingdom

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

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Belgium - Requisition Number: R-010515

United States - Requisition Number: R-007909

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are searching for the best talent for a Randomization & Trial Supply Management (RTSM) Lead to be located in Horsham, PA; Titusville, NJ; High Wycombe, United Kingdom; or Beerse, Belgium.

Purpose: The RTSM team is proud to be an integral member of Johnson & Johnson's Clinical Supply Chain organization. With the highest degree of quality and integrity, we deliver innovative Randomization & Trial Supply Management (RTSM) solutions that bring investigators, patients and loved ones “Hope in a Box”! We are seeking a new team member who is passionate about effectiveness, innovation and bringing true value to our patients.

You Will Be Responsible For

• Managing RTSM systems to meet the needs of the study/program and internal partners.
• Providing leadership and subject matter expertise for RTSM from start to finish.
• Leading the cross-functional study team through the RTSM system lifecycle: requirement gathering, design and development, changes of scope and system requirements updates, user acceptance testing, and all related maintenance and close-out activities.
• Serving as the point of contact specific to inspection readiness activities between the study team and the RTSM supplier.
• Owning the resolution of issues under the supervision of the RTSM Director or Associate Director, as applicable.
• Focusing in and specializing on one or more activity areas within the development process, such as leading design and solution decisions, based on needs within the team.
• Meeting trial requirements by providing effective design solutions in study RTSM system builds.
• Problem-solving on emerging and challenging requirements.
• Identifying and addressing current solutions where opportunities for improvement exist.
• Conducting Lessons Learned sessions following the completion of study start-up activities and throughout other phases of the clinical development process.
• Representing the team as an RTSM expert at cross-functional meetings and at external professional meetings.
• Seeking out different and better design solutions to today’s trials.
• Immersing yourself in a particular therapeutic area(s) or program(s) to fully understand the requirements, goals, priorities, and challenges of that área.
• Being a Agent of Change and Improvement, with an outlook and a focus toward tomorrow.
• Maintaining an awareness of industry benchmarks and evaluating innovative new technologies to ensure RTSM designs are at the ‘gold standard’ level of performance.
• Continually assessing new emerging technologies to optimize operational efficiencies.
• Contributing to and/or leading a successful RTSM strategy for a diverse portfolio of trials.
• Ensuring that principles of Credo and Business Conduct Policy, Purchasing Code of Conduct, Healthcare Compliance and Ethical Code of Conduct of Pharmaceutical Medicine are used in supplier relationships.
• Building a healthy and effective internal and external network.
• Exhibiting proactive thinking, independent problem solving and attention to detail.
  
  

Qualifications / Requirements

• A minimum of a Bachelor’s degree is required. An advanced degree is preferred.
  
  

Experience & Skills

• 3+ years of proven experience in clinical trial conduct is required.
• 2+ years of hands on experience with Randomization & Trial Supply Management (IRT) trial software is required.
• Experience in making RTSM design decisions in roles like a Business Analyst, System Designer, Project Manager, or Helpdesk member is preferred.