Senior Analyst, Clinical Trial Learning

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Clinical Trial Learning & Development Senior Analyst. Remote work options within the United States may be considered on a case-by-case basis and if approved by the company.

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.

The Clinical Trial Learning and Development (CTL&D) organization develops and delivers learning strategy, design, and operations for Janssen R&D staff and investigational site staff participating in Janssen sponsored clinical trials. This includes assessing needs and crafting effective, efficient, and engaging learning solutions, training plans, and assets resulting in shortened study start-up cycle times, increased learning effectiveness & efficiency for conduct of clinical trial activities, and overall improvement in site satisfaction. The CTL&D organization is a critical component to Janssen’s goal of becoming the Sponsor of Choice.

The Senior Analyst provides support to the CTL&D Therapeutic Area (TA) Learning Strategists for protocol-specific training to ensure a standardized, fit-for-purpose training strategy and plan is developed, documented, and implemented for all Sponsor Staff and Investigative Site Staff participating in Janssen clinical trials. This individual will work with Therapeutic Area Study Teams, Learning Strategists, and the business process owner, as well as the Learning Systems Solutions Team, to ensure an effective approach to training plan development that includes considerations for re-purposing existing materials, when appropriate.

The CTL&D, Senior Analyst may be asked to contribute to other process improvement initiatives or non-protocol-specific training strategies, content design and development as assigned.

Key Responsibilities:

- Lead and manage triage of workload related to Global Protocol Training Plan (GPTP) for the portfolio.
- Develop and document the Global Protocol Training Plan (GPTP) for assigned protocols
- Partner with other CTL&D where applicable in conducting needs assessments to determine the full scope of the program and/or study level training need while considering potential challenge areas to focus on based on available data and feedback from study team and relevant stakeholders. Interpret and understand program level guidance to execute study specific training plans
- Support end to end development of sponsor staff and investigational site staff training strategy from concept to the design, development, and maintenance of effective training materials in accordance with Standard Operating Procedures and Good Clinical Practice while also considering how to stimulate effective learning
- Responsible for the maintenance of the training library and relevant workflows, serving as a conduit between the EBIS Learning Systems Solutions, study teams, and TA leads as appropriate
- Manages content in training library with appropriate mechanisms in place to support version control and compliance
- Responsible for central management of materials in partnership with TA Leads
- Responsible for successful migration of legacy training processes and/or systems for defined studies, where applicable
- Ensure clinical trial training materials are available to support timely study start up activities
- Partner with TA Leads to ensure alignment of overall training strategies and harmonized approaches/requirements
- Supports oversight of operations process, tools, and reporting and ensures necessary training/support established
- Contribute to and develop best practices /lessons learned within CTL&D
- Ensure global study teams (i.e. - SM, LTM) provide input to clinical trial training plans
- Lead onboarding new CTL&D Analysts and TA Leads (if applicable) as well as mentoring others on clinical trial training process and requirements
- Responsible for championing the protocol specific training process and providing support across the organization

**Qualifications**

**Education**:
A minimum of a Bachelor’s degree is required.

Experience & Skills:
Required
- A minimum of 3 years of experience in Pharmaceuticals is required.
- Experience in Clinical Operations with experience in study start up and maintenance
- Strong verbal and written communication skills and the ability to communicate across all levels of the organization
- Ability to manage change and quickly adapt to a rapidly changing environment
- Must be customer focused and have the ability to lead process improvement initiatives from both an internal lens and through a lens of external stakeholders (e.g., Clinical Trial Investigators)
- Proactive, and willing to challenge the status quo. Ability to manage change positively and se