Janssen Research & Development, LLC, a member
of Johnson & Johnson's Family of Companies, is recruiting for a Senior
Site Manager - Oncology. 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.
Site Manager (Senior SM) will serve as the primary
contact point between the Sponsor and the Investigational Site. This individual will be assigned to trial
sites to ensure inspection readiness through compliance with the clinical trial
protocol, company Standard Operating Procedures (SOPs), Good Clinical Practices
(GCPs), and applicable regulations and guidelines from study start-up through
to site closure. Responsibilities may
include assisting with site selection, pre-trial assessment, subject
recruitment and retention planning, site initiation, on-site and remote
monitoring and close-out activities. Partner
with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Clinical
Trial Manager (CTM) to ensure overall site management while performing trial
related activities for assigned protocols. May contribute to process improvement,
training and mentoring of other SMs.
+ Act as primary local
company contact for assigned sites for specific trials.
+ May participate in
site feasibility and/or pre-trial site assessment visits.
+ Attend/participate in
investigator meetings as needed.
+ Execute activities
within site initiation and start-up, preparation and conduct of site monitoring
(including remote monitoring), site management (by study specific systems and
other reports/dashboards) and site/study close-out according to SOPs, Work Instructions
(WIs) and policies.
+ Implement of
analytical risk-based monitoring model at the site level and to work with site
to ensure timely resolution of issues found during monitoring visits.
+ Ensure site staff are
trained and the corresponding training records are complete and accurate at any
time point during all trial phases.
+ Work in close
collaboration with LTM and central study team for the activities during site
activation phase in order to speed up the process and activate the site in
shortest possible timeframe.
+ Contribute to site
level recruitment and retention strategy and contingency planning and
implementation in partnership with other functional areas.
+ Ensure site study
supplies (such as Non-Investigational Product (IP), lab kits, etc.) are
adequate for trial conduct.
+ Ensure that clinical
drug supplies are appropriately used, handled and stored and returns are
accurately inventoried and documented.
+ Arrange for the
appropriate destruction of clinical supplies.
+ Ensure site staff
complete data entry and resolve queries within expected timelines.
+ Ensure accuracy,
validity and completeness of data collected at trial sites
+ Ensure that all
Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints
(PQCs) are reported within the required reporting timelines and documented as
appropriate. For AEs/SAEs, ensures that
they are consistent with all data collected and with the information in the
+ Maintain complete,
accurate and timely data and essential documents in relevant systems utilized
for trial management.
+ Fully document trial
related activities, in particular monitoring. Writes visit reports and
follow-up letter in accordance with the SOPs. Promptly communicates relevant
status information and issues to appropriate stakeholders.
+ Review study files for
completeness and ensures archiving retention requirements are met, including
storage in a secure area at all times.
+ Collaborate with LTM
for documenting and communicating site/study progress and issues to trial
+ Attend regularly
scheduled team meetings and trainings.
+ Comply with relevant
training requirements. Act as local expert in assigned protocols. Develops
therapeutic knowledge sufficient to support role and responsibilities.
+ Work closely with LTM
to ensure Corrective Action Preventative Action (CAPA) is completed for Quality
Assurance (QA) site audits and for quality issues identified at the site during
routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit
+ Prepare trial sites
for close out, conduct final close out visit.
+ Track costs at site
level and ensure payments are made, if applicable.
+ Establish and maintain
good working relationships with internal and external stakeholders, investigators,
trial coordinators and other site staff.
+ May participate in the
Health Authority (HA) and Independent Ethics Committee
(IEC)/Institutional Review Board (IRB) submission and notification
processes as required/appropriate.
+ Act as a point of
contact in site management practices.
+ May be assigned as a
coach and mentor to a less experienced SM.
+ May contribute to
process improvement and training.
+ Lead and/or
participate in special initiatives as assigned.
+ May assume additional
responsibilities or special initiatives such as "Champion" or Subject Matter
+ 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.
United States-New Jersey-Raritan-
North America-United States
Janssen Research & Development, LLC (6084)
Clinical Trial Administration