J&J Family of Companies Lead, Clinical Trial Management Business Support in Raritan, New Jersey
Janssen Research & Development, LLC, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Lead, Clinical Trial Management Business Support. This position can be based in Titusville, NJ, Raritan, NJ, Spring House, PA, Horsham, PA or remote 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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Lead, Clinical Trial Management Business Support, is responsible for providing business support in study build and setup, maintenance of templates, user administration, and change management for Clinical Trial Management System (CTMS), Grants Manager (GM) applications, and other applications supported by the Clinical Trial Management Solutions team. Lead is also responsible for guiding team members in projects and support activities. Responsibilities will include:
· Work with Study Teams and partners during study build process to create/maintain the following in CTMS: Study, Country, Site, Contacts, and Institution records.
o Create and set up templates such as Health Authority, IRB/IEC, Financial Disclosure, Subject Visit, Visit/Trip Report, etc.
o Update system dropdown values and Create/Update assignments, configurations, properties, attributes, triggers, and parameters in the system.
· Provide general business support and troubleshoot system issues as well as integration errors between CTMS and other applications
· Coordinate User Acceptance Testing (UAT) activities
· Develop and maintain Job Aides for Business Support team to perform study build and support activities to the highest standard
· Responsible for SLA metrics and reporting
· Run SQL queries and create/generate reports
· Lead meetings and provide guidance to team members
· Lead projects as required
· Support manager in supervising external resources (contractors, flex staff, and/or) on team
· May have direct reports to manage
A minimum of a Bachelor’s degree with at least 6 years of relevant experience is required
A minimum of 4 years business systems and/or applications is required
Experience in clinical trial execution with a pharmaceutical, medical device company and/or a CRO is preferred
Solid understanding of GCP and FDA Code of Federal Regulation is preferred
Proficiency with CTMS, TMF and/or other clinical trial management system and processes is required
Knowledge of the Clinical Trial Management process is preferred
Oracle SQL experience is preferred
Experience with supporting or leading a project is preferred
This position will require up to 10% travel (mainly local between sites in NJ and PA)
United States-Pennsylvania-Spring House
North America-United States-Pennsylvania-Horsham, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)
Clinical Data Management