Site Manager, Oncology - Western U.S. (1 of 2)
Company: Disability Solutions
Location: Raritan
Posted on: May 4, 2024
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Job Description:
Janssen Research & Development, LLC, is recruiting for a Site
Manager, Global Clinical Operations - Oncology to be remote in the
Western Region ( AZ, CA, CO, ID, MT, NE, ND, NM, NV, OR, SD, UT,
WA, WY, HI, AK) of the United States. A Site Manager I (SM I)
serves as the primary contact point between the Sponsor and the
Investigational Site. A SM I is assigned to trial sites to ensure
inspection readiness through compliance with the clinical trial
protocol, company Standard Operating Procedures (SOP), Good
Clinical Practice (GCP), 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. The SM I
will 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 assist in process improvement and training.
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Responsibilities: --- Acts as primary local company contact for
assigned sites for specific trials --- May participate in site
feasibility and/or pre-trial site assessment visits ---
Attends/participates in investigator meetings as needed ---
Responsible for driving 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. Responsible for the
implementation 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 --- Ensures site staff are
trained and the corresponding training records are complete and
accurate at any time point during all trial phases. Responsible 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 ---
Assists with site level recruitment strategy and contingency
planning and implementation in partnership with other functional
areas --- Ensures site study supplies (such as Non-Investigational
Product (IP), lab kits, etc.) are adequate for trial conduct ---
Ensures that clinical drug supplies are appropriately used, handled
and stored and returns are accurately inventoried and documented
--- Arranges for the appropriate destruction of clinical supplies
--- Ensures site staff complete data entry and resolve queries
within expected timelines --- Ensures accuracy, validity and
completeness of data collected at trial sites --- Ensures 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 --- Maintains complete,
accurate and timely data and essential documents in relevant
systems used for trial management --- Fully documents 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
--- Reviews study files for completeness and ensures archiving
retention requirements are met, including storage in a secure area
at all times --- Collaborates with LTM for documenting and
communicating site/study progress and issues to trial central team
--- Attends regularly scheduled team meetings and trainings ---
Complies with relevant training requirements. Act as local expert
in assigned protocols. Develops therapeutic knowledge sufficient to
support role and responsibilities --- Works 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) --- Prepares
trial sites for close out, conduct final close out visit --- Tracks
costs at site level and ensure payments are made, if applicable ---
Establishes and maintains good working relationships with internal
and external stakeholders in particular investigators, trial
coordinators and other site staff --- May participate in the Health
Authority (HA) and IEC/IRB submission and notification processes as
required/appropriate --- Acts as a point of contact in site
management practices --- May contribute to process improvement and
training. *This is not a comprehensive listing of job functions
Keywords: Disability Solutions, Plainfield , Site Manager, Oncology - Western U.S. (1 of 2), Healthcare , Raritan, New Jersey
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