Specialist, Site Manager - Cross Therapeutic Area
Company: J&J Family of Companies
Location: Jackson
Posted on: May 28, 2023
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Job Description:
Specialist, Site Manager - Cross Therapeutic Area -
2306118307W
Description
Janssen Research & Development, LLC, a member of Johnson &
Johnson's Family of Companies, is recruiting for a Senior Site
Manager. 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, cardiovascular and metabolism, and pulmonary
hypertension. Please visit http://www.janssenrnd.com for more
information.
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.
Principal Responsibilities:
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 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.
Write 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 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
Visit (OSQMV).
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 Expert".
Qualifications
A minimum of a Bachelor's degree in Life Sciences, Nursing or
related scientific field is required.
A minimum of 6 years of clinical trial monitoring experience is
required.
Clinical research monitoring experience in the following
Therapeutic Areas preferred: Oncology, Immunology, Infectious
Diseases and Vaccines, Neuroscience, Cardiovascular and Metabolism,
Pulmonary Hypertension, Retinal.
Experience with Phase II and Phase III Clinical Trials is
preferred.
Knowledge of the drug development process, including GCPs, FDA Code
of Federal Regulations, company SOPs, local laws and regulations,
assigned protocols, associated protocol specific procedures and
monitoring guidelines is required.
Experience mentoring/coaching and providing training to others is
preferred.
Strong computer skills in appropriate software applications and
related clinical systems required.
Must have strong written and verbal communication skills.
Must have strong leadership skills with the ability to lead
initiatives.
Must have a flexible mindset with the ability to work at a fast
pace within small exploratory international study teams in a
rapidly changing environment.
The ability to work on multiple trials in parallel in different
disease areas is preferred.
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.
The anticipated base pay range for this position in the San
Francisco Bay Area, CA is $116,700 to $187,795.
The anticipated base pay range for this position in all other US
locations is $102,000 to $163,300.
The Company maintains highly competitive, performance-based
compensation programs. Under current guidelines, this position is
eligible for an annual performance bonus in accordance with the
terms of the applicable plan. The annual performance bonus is a
cash bonus intended to provide an incentive to achieve annual
targeted results by rewarding for individual and the corporation's
performance over a calendar/ performance year. Bonuses are awarded
at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate
in the following Company sponsored employee benefit programs:
medical, dental, vision, life insurance, short- and long-term
disability, business accident insurance, and group legal
insurance.
Employees may be eligible to participate in the Company's
consolidated retirement plan (pension) and savings plan
(401(k)).
Employees are eligible for the following time off benefits:
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who
reside in the State of Washington - up to 56 hours per calendar
year
Holiday pay, including Floating Holidays - up to 13 days per
calendar year
Work, Personal and Family Time - up to 40 hours per calendar
year
For additional general information on company benefits, please go
to: https://www.careers.jnj.com/employee-benefits
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 NA-US-New Jersey-Raritan
Other Locations NA-United States
Organization Janssen Research & Development, LLC (6084)
Relocation Eligible: No
Job Function Clinical Trial Administration
Req ID: 2306118307W
Keywords: J&J Family of Companies, Jackson , Specialist, Site Manager - Cross Therapeutic Area, Hospitality & Tourism , Jackson, Mississippi
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