Clinical Trial Learning & Development TA Team Lead (1 of 3)

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for aClinical Trial Learning & Development Therapeutic Area Team Lead. This position can be located remotely in North America or Europe, preferably near Spring House, PA; Malvern, PA; Raritan, NJ; Titusville, NJ; High Wycombe, Beerse or Leiden. The position will require up to 20% travel depending on location.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com for more information.

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

The Clinical Trial Learning and Development (CTL&D) organization will develop strategy and delivery of industry leading training for investigator site staff and sponsor staff participating in Janssen sponsored clinical trials. This includes material design, development, and maintenance, and will also include delivery of training materials via an on-line Learning Management System (eLMS) which result in shortened study start-up cycle times, increased learning effectiveness for conduct of clinical trial activities and overall improved site staff satisfaction. The CTL&D organization is a critical component to Janssen's goal of becoming the Sponsor of Choice.

The Clinical Learning & Development Therapeutic Area (CTL&D) will be the single point of contact for the assigned Therapeutic Area(s) to ensure a standardized, fit for purpose training plan is developed and executed for all Investigative Site Staff participating in Janssen Clinical Research. He/she will work with Therapeutic Area Teams, Learning Strategy & Design as well as CTL&D Operations to ensure the most effective approach to training material development inclusive of leveraging appropriate existing materials that can be repurposed to create synergies and efficiencies, while also supporting one face of Janssen.

Principal responsibilities will include:

  • Act as the Single Point of Contact for assigned Therapeutic Area(s) for clinical trial training in development of Program learning strategy
  • Lead end to end development of investigator site staff training materials within the assigned TA to ensure the design, development, and maintenance of effective Training Materials in accordance with Standard operating procedures and Good Clinical Practice
  • Partner with content SMEs to obtain necessary content for development of training materials according to the training needs assessment and compliance requirements
  • Ensure clinical trial training materials are available to sites to ensure no delays in study start up and execution for sites
  • Create and maintain liaisons with key stakeholders in GCDO, TA(s) and BRQC to ensure timely development and distribution of site staff training materials for study start up and maintenance training needs
  • Ensure a high level of customer service to Therapeutic Area Teams
  • Partner with other TA Leads for clinical trial training to ensure alignment of overall training strategies and harmonized approaches/ requirements that support the creation of one face of Janssen
  • Share best practices /lessons learned within CTL&D and with TAs in development and execution of clinical trial training
  • Ensure site manager input to clinical trial training materials through focus panels and ongoing engagement across regions
  • Assist in onboarding new CTL&D TA leads as well as mentoring others on clinical trial training process and requirements
  • Contribute to shaping the approach that will support continuous learning and knowledge management
  • Track Key Performance Indicators (KPIs) within assigned TAs for clinical trial training process


  • Qualifications
    • A Bachelor's Degree is required
    • At least 8 years of relevant experience is required, preferably in Clinical Operations with experience in study start up and maintenance
    • Strong Project Management and Training/Mentoring skills, and strong analytical skills are required
    • Demonstrated experience mentoring team members is preferred
    • Demonstrated ability leading global matrixed teams and a proven track record of working cross functionally within a global environment is required
    • Experience and ability to quickly adapt to a rapidly changing environment is required
    • Demonstrated ability to influence without authority and manage change is required
    • Experience in a customer focused environment, leading process improvement initiatives from an internal lens of time, cost and quality and through an external lens of our Clinical Trial Investigators is preferred
    • Ability to manage change positively and sees change as an opportunity to improve processes and tools is preferred
    • Strong computer skills with an ability to understand, access and leverage technology is required
    • Knowledge of continuous improvement tools and application to business process is preferred


    Primary Location
    United States-Pennsylvania-Spring House
    Other Locations
    North America, Europe/Middle East/Africa
    Organization
    Janssen Research & Development, LLC. (6084)
    Job Function
    Clinical Trial Administration
    Requisition ID
    00001C5P


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