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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.

• 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