Randomization & Trial Supply Management Manager, IRT

Janssen Research & Development, part of the Johnson & Johnson Family of Companies, is recruiting for a Randomization & Trial Supply Management Manager, IRT position within Clinical Supply Chain (CSC). The position can be based in Malvern, PA, Titusville, NJ, High Wycombe, UK, or Beerse, Belgium.

 

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical is part of the Janssen Pharmaceutical Companies. 

 

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

This position is accountable for the design of RTSM systems to meet the needs of the study/program and internal partners.

Responsibilities:

• Provide leadership and subject matter expertise for Randomization and Trial Supply Management systems, from start to finish.
• Lead 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.
• Serve as the point of contact specific to inspection readiness activities between the study team and the RTSM supplier.
• Own the resolution of issues under the supervision of the RTSM Director or Associate Director, as applicable.
• Based on needs within the team, focus in and specialize on one or more activity area within the development process, such as leading design and solution decisions.
• Meeting trial requirements by providing effective design solutions in study RTSM system builds.
• Problem-solve on emerging and challenging requirements.
• Identify and address current solutions where opportunities for improvement exist.
• Conduct Lessons Learned sessions following the completion of study start-up activities and throughout other phases of the clinical development process.
• Represent the team as an RTSM expert at cross-country meetings and at external professional meetings.
• You may be provided an opportunity to become responsible for new sub teams within RTSM as the team transforms from generalists to specialists for trial activities.
• Seek out different and better design solutions to today’s trials.
• Immerse yourself in a particular therapeutic area(s) or program(s) to fully understand the requirements, goals, priorities, and challenges of that area.
• Be an Agent of Change and Improvement, with an outlook and a focus toward tomorrow.
• Maintain an awareness of industry benchmarks and evaluating innovative new technologies to ensure RTSM designs are at the ‘gold standard’ level of performance.
• Continually assess new emerging technologies to optimize operational efficiencies.
• Contribute to and/or leading a successful RTSM strategy for a diverse portfolio of trials. This will result in RTSM systems that are flexible, adaptable, and novel, yet still providing the quality needed to maintain trial integrity and patient safety.
• Ensure 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.
• Build a healthy and effective network.
• Exhibit proactive thinking, independent problem solving and attention to detail.

Qualifications

Required:

• A minimum of a Bachelor’s degree.
• A minimum of 8 years of business experience in running clinical trials.
• A minimum of 5 years of experience with RTSM (IRT) trial software.

 

Preferred:

• An Advanced degree.
• Experience in a Business Analyst or System Designer position making IRT design decisions.

 

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-New Jersey-Titusville-1125 Trenton Harbourton Road
Other Locations
North America-United States-Pennsylvania-Malvern, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
2105973589W

Salary : $0