Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Site Manager - Neuroscience/Immunology, to be regionally based in 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.
The Senior Site Manager will be responsible for site recruitment, patient recruitment and retention planning, site initiation, monitoring and close-out. This individual will ensure study related activities in compliance with all Global Clinical Operations (GCO) Standard Operating Procedures (SOPs), policies and regulatory requirements from start-up through data-base lock. Partner with the Clinical Trial Assistant (CTA)/Investigator Document Assistants (IDA), Local Trial Manager (LTM) and Global Trial Manager (GTM) to ensure overall site management while performing trial related activities for assigned protocols. Serve as primary point of contact and liaison between investigational site staff and GCO study team once site is initiated. Represent functional area(s) in divisional/company-wide process initiatives.
Principal responsibilities include the following:
Participate in Site/Investigator selection process by providing recommendations from local area.
Assess site experience, facility, and EDC capabilities to perform study activities (e.g., EDC, imaging).
Additionally he/she is responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
Ensure Visit Reports are written and submitted via electronic Trial Master File (eTMF) within 5 working days.
Ensure site staff resolve data queries, and works with sites to ensure data timelines are met.
Maintain accurate and timely data in systems utilized for clinical trial management and also updates site payments in Clinical Trial Management System (CTMS).
Ensure, in collaboration with LTM, the timely and accurate data collection, documentation and communication of site/study progress and issues.
Plan, conduct and document site staff training and monitors site performance.
Update training matrix in SharePoint as necessary and ensure all site personnel training documentation is on file at the site and in the Investigator File.
Contribute to site level recruitment strategy and contingency plan in partnership with other functional areas to achieve clinical research targets.
Present/participate in Investigator Meetings as needed and also monitors expiry date of Investigational Product and ensures study supply strategy is adequate.
Work with LTM to ensure Corrective Action/Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and also attend regularly scheduled team meetings and trainings.
Mentor new hires with supervision and serve as Lead SM/SM EDC Specialist for a specific trial as needed.
In conjunction with LTM, review eCRFs and Completion Guidelines and participate in EDC User Acceptance Testing (UAT) testing and special initiatives as needed.
- A minimum of a Bachelor’s degree or equivalent clinical experience is required.
- A minimum of 4 years of clinical monitoring experience is required.
- Clinical research monitoring experience in Neuroscience/Immunology is preferred.
- Solid understanding of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required.
- Strong communication and computer skills required.
- Willingness to travel 50%, approximately 2-3 days per week, with overnight stay, is required.
- A valid Driver's License issued in one of the 50 United States and a good driving record is required.
United States-New Jersey-RaritanOther Locations
North America-United StatesOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Trial AdministrationRequisition ID