Janssen Research & Development, LLC, a member ofJohnson & Johnson’s Family of Companies, is recruiting for a Senior Site Manager - Early Development and Clinical Pharmacology (Oncology). This position can be located remotely within the United States, preferably in the Northeast or Midwest. 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 ED&CP Senior Site Manager will be responsible for site recruitment, patient recruitment and retentionplanning, site initiation, monitoring and close-out for Phase 0 to IIa trials.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), Local Trial Manager (LTM) and Global Trial Leader (GTL) 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.
- Assess site experience, facility, and Electronic Data Capture (EDC) capabilities to perform study activities (e.g. EDC, imaging).
- Execute activities within site initiation and start-up, site monitoring, first dose activities, site management and site/study close-out according to internal SOPs/Work Instructions (WIs)/Instructions for Use (IFUs) and policies.
- Ensure Visit Reports are written and submitted via Veeva-Trial Master File (V-TMF) within 5 working days.
- Ensure site staff resolve data queries and work with sites to ensure data timelines are met.
- Maintain accurate and timely data in systems utilized for clinical trial management and update 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 monitor site performance.
- Update training documentation 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 milestones.
- Present/participate/prepare for Investigator Meetings or Site Initiation Visits as needed
- Accountability for Investigational Product
- Work with LTM to ensure Corrective Action/Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and attend regularly scheduled team meetings and trainings.
- In conjunction with LTM, review electronic Case Reports Forms (eCRFs) and Completion Guidelines.
- A minimum of an Associate’s degree or completion of a Nursing Program (RN) is required. A Bachelor’s degree in a Health or Science discipline is preferred.
- A minimum of 4 years of clinical monitoring experience or equivalent is required.
- Clinical research monitoring experience in Oncology is required.
- Experience with Phase 0 to IIa Clinical Trials required.
- Strong knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required.
- Experience working with computer software applications is required.
- Must have strong communication skills.
- Willingness to travel 50%, approximately 2-3 days per week, with overnight stays (1-2 nights on average), is required.
- A valid Driver’s License issued in one of the 50 United States and a good driving record is required.
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.
Primary LocationNorth America-United States-Pennsylvania-Spring HouseOther LocationsNorth America-United StatesOrganizationJanssen Research & Development, LLC. (6084)Relocation EligibleNoJob FunctionClinical Trial Administration
Internal ID: 0631170919
Location/Region: Spring House, PA (US)