Senior Site Manager.
Company: Johnson & Johnson
Posted on: January 16, 2022
Janssen Research & Development, LLC, a member of Johnson &
Johnson's Family of Companies, is recruiting for a Senior Site
Manager, supporting the Oncology and Oncology Solid Tumor
Therapeutic Areas. This position can be located remotely within the
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, cardiovascular and metabolism, and pulmonary
hypertension. Please visit http://www.janssenrnd.com for more
The Senior 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
May participate in site feasibility and/or pre-trial site
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)
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
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
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
Arrange for the appropriate destruction of clinical supplies.
Ensure site staff complete data entry and resolve queries within
Ensure accuracy, validity and completeness of data collected at
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 source documents.
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
Collaborate with LTM for documenting and communicating site/study
progress and issues to trial central team.
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
Prepare trial sites for close out, conduct final close out
Track costs at site level and ensure payments are made, if
Establish and maintain good working relationships with internal and
external stakeholders, investigators, trial coordinators and other
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 Expert".
A minimum of an Associate's degree or completion of a Nursing
Program (LPN) is required. A Bachelor's degree in Health, Science
or Nursing (RN) is preferred.
A minimum of 2 years of clinical trial monitoring experience is
Clinical research monitoring experience in the Oncology Therapeutic
Area is required.
Experience with Oncology Solid Tumor clinical trials preferred.
Experience with Late Development, Phase II and Phase III clinical
Knowledge of the drug development process, including Good Clinical
Practices (GCPs) and FDA Code of Federal Regulations, is
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
United States-New Jersey-Raritan-920 US Highway 202
North America-United States
Janssen Research & Development, LLC (6084)
Keywords: Johnson & Johnson, Trenton , Senior Site Manager., Professions , Raritan, New Jersey
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