Analyst, Clinical Trial Learning and Development Operations

Job description

Janssen Research and Development, LLC, a member of Johnson and Johnson's Family of Companies, is recruiting for an Analyst, Clinical Trial Learning and Development Operations. This position can be located remotely within the United States.

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 Analyst, Clinical Trial Learning and Development Operations will be an administrator/Training Manager of eLMS and the Clinical Trial Training Library. This individual will also contribute to project work delivery, manage CTL&D metrics and compliance reporting. Work with CTL&D Therapeutic Area (TA) Leads and ensure the necessary technical connections with Drug Development and Enabling Business Information Solutions (EBIS) to ensure material is properly loaded into appropriate learning systems. Ensure maintenance of a fit for purpose training repository to ensure consistency among TAs and ability to re-purpose materials.

Principal Responsibilities:
· System Administrator, responsible for providing permissions to users, converting, loading, and testing content, for assigned Therapeutic Area Teams for Clinical Trial Training.
· Ensure training is appropriately assigned to investigator site staff within eLMS. Support study teams to ensure training is completed according to timelines and appropriately tracked.
· Coordination of timely notification of training assignments to site staff and sponsor staff as appropriate.
· Serves as the technical link between the trial teams, EBIS and LMS Vendors (i.e. Drug Dev, Bracket, etc.) including technical LMS support and delivering applicable training as required.
· Maintenance of the training library, relevant workflows, and permissions, enabling easy access for re-purposing existing content where appropriate.
· Manage content of training repository with appropriate mechanisms in place to support version control and compliance.
· Central management of materials in partnership with CTL&D TA Lead.
· Oversee migration of legacy training processes for defined studies.
· Ensuring version control of training materials
· Contribute to lessons learned and overall continuous improvement.
· Support oversight of operations process, tools and reporting and ensures necessary training/support established.
· Support reporting of performance metrics per CTL&D agreed Key Performance Indicators (KPIs). Proactively identify issues to study team contacts and collaboratively develop solutions.
· Contribute to capturing lessons learned/best practices.
· Championing the Clinical Trial Training process and providing help across the organization through development of administrative procedures and documents.
· Contribute to resource management data collection

Desired profile

Qualifications :

·  A minimum of a Bachelor's degree is required.
·  A minimum of 3 years of experience with the management/administration of Learning Management Systems is required.
·  Pharmaceutical industry experience is preferred.
·  Clinical research experience is required.
·  Experience with global clinical trial operations is preferred.
·  Knowledge of document archiving with exposure to a regulated industry (i.e. Pharmaceutical, Telecommunication, Government, etc.) is required.
·  Proficiency in using enterprise business systems, processes and workflows is required.
·  Strong technical troubleshooting skills required
·  Experience working with both internal and external customers to correct technical difficulties is required.
·  Knowledge of continuous improvement tools and applications preferred.
·  Experience working in a global environment is preferred.
·  Must have strong communication and interpersonal skills.
·  Must have the ability to work independently.
·  Must be detail-oriented, proactive and willing to challenge the status quo.
·  The ability to collaborate with all levels in a cross-functional team environment is required.
·  This position will require up to 10% domestic and international travel.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.