Employment Type: Full-Time
Industry: Non-Executive Management
Janssen Research & Development, LLC, a memberof Johnson & Johnson's Family of Companies, is recruiting for a SeniorSite Manager - Oncology. This positioncan 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 preventingsome of the most devastating and complex diseases of our time. And we pursuethe most promising science, wherever it might be found. Janssen Research & Development, LLC discovers anddevelops innovative medical solutions to address important unmet medical needsin oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascularand metabolic diseases. Please visit for more information. The SeniorSite Manager (Senior SM) will serve as the primarycontact point between the Sponsor and the Investigational Site. This individual will be assigned to trialsites to ensure inspection readiness through compliance with the clinical trialprotocol, company Standard Operating Procedures (SOPs), Good Clinical Practices(GCPs), and applicable regulations and guidelines from study start-up throughto site closure. Responsibilities mayinclude assisting with site selection, pre-trial assessment, subjectrecruitment and retention planning, site initiation, on-site and remotemonitoring and close-out activities. Partnerwith the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and ClinicalTrial Manager (CTM) to ensure overall site management while performing trialrelated activities for assigned protocols. May contribute to process improvement,training and mentoring of other SMs. PrincipalResponsibilities: + Act as primary localcompany contact for assigned sites for specific trials. + May participate insite feasibility and/or pre-trial site assessment visits. + Attend/participate ininvestigator meetings as needed. + Execute activitieswithin site initiation and start-up, preparation and conduct of site monitoring(including remote monitoring), site management (by study specific systems andother reports/dashboards) and site/study close-out according to SOPs, Work Instructions(WIs) and policies. + Implement ofanalytical risk-based monitoring model at the site level and to work with siteto ensure timely resolution of issues found during monitoring visits. + Ensure site staff aretrained and the corresponding training records are complete and accurate at anytime point during all trial phases. + Work in closecollaboration with LTM and central study team for the activities during siteactivation phase in order to speed up the process and activate the site inshortest possible timeframe. + Contribute to sitelevel recruitment and retention strategy and contingency planning andimplementation in partnership with other functional areas. + Ensure site studysupplies (such as Non-Investigational Product (IP), lab kits, etc.) areadequate for trial conduct. + Ensure that clinicaldrug supplies are appropriately used, handled and stored and returns areaccurately inventoried and documented. + Arrange for theappropriate destruction of clinical supplies. + Ensure site staffcomplete data entry and resolve queries within expected timelines. + Ensure accuracy,validity and completeness of data collected at trial sites + Ensure that allAdverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints(PQCs) are reported within the required reporting timelines and documented asappropriate. For AEs/SAEs, ensures thatthey are consistent with all data collected and with the information in thesource documents. + Maintain complete,accurate and timely data and essential documents in relevant systems utilizedfor trial management. + Fully document trialrelated activities, in particular monitoring. Writes visit reports andfollow-up letter in accordance with the SOPs. Promptly communicates relevantstatus information and issues to appropriate stakeholders. + Review study files forcompleteness and ensures archiving retention requirements are met, includingstorage in a secure area at all times. + Collaborate with LTMfor documenting and communicating site/study progress and issues to trialcentral team. + Attend regularlyscheduled team meetings and trainings. + Comply with relevanttraining requirements. Act as local expert in assigned protocols. Developstherapeutic knowledge sufficient to support role and responsibilities. + Work closely with LTMto ensure Corrective Action Preventative Action (CAPA) is completed for QualityAssurance (QA) site audits and for quality issues identified at the site duringroutine monitoring and other visit types, e.g. On Site Quality Monitoring Visit(OSQMV). + Prepare trial sitesfor close out, conduct final close out visit. + Track costs at sitelevel and ensure payments are made, if applicable. + Establish and maintaingood working relationships with internal and external stakeholders, investigators,trial coordinators and other site staff. + May participate in theHealth Authority (HA) and Independent Ethics Committee(IEC)/Institutional Review Board (IRB) submission and notificationprocesses as required/appropriate. + Act as a point ofcontact in site management practices. + May be assigned as acoach and mentor to a less experienced SM. + May contribute toprocess improvement and training. + Lead and/orparticipate in special initiatives as assigned. + May assume additionalresponsibilities or special initiatives such as "Champion" or Subject MatterExpert". Qualifications + 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 2 years of clinical trial monitoring experience is required. + Clinical research monitoring experience in Oncology is required. + Experience with CAR-T (Cell and Gene Therapy) is preferred. + Experience with Phase II and Phase III Clinical Trials is preferred. + Knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required. + Strong computer skills in appropriate software applications and related clinical systems required. + Must have strong written and oral 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. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-New Jersey-Raritan- Other Locations North America-United States Organization Janssen Research & Development, LLC (6084) Job Function Clinical Trial Administration Requisition ID 043#######
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