Senior Site Manager, Oncology - Southeastern U.S.
Company: Disability Solutions
Location: Raritan
Posted on: April 20, 2024
Job Description:
Janssen Research & Development, L.L.C., a division of Johnson &
Johnson's Family of Companies is recruiting for a Senior Site
Manager, Global Clinical Operations - Oncology, to be remote in the
Southeast Region (DC, VA, MD, NC, SC, GA, FL, WV) of the United
States. A Site Manager II (SM II) serves as the primary contact
point between the Sponsor and the Investigational Site. A SM II 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. Site Manager 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. A SM II
may also be involved with process improvement, training and
mentoring of other Site Managers. At the Janssen Pharmaceutical
Companies of Johnson & Johnson, we are working to create a world
without disease. Transforming lives by finding new and better ways
to prevent, intercept, treat and cure disease inspires us. We bring
together the best minds and pursue the most promising science. We
are Janssen. We collaborate with the world for the health of
everyone in it. Learn more at www.janssen.com and follow us
@JanssenGlobal. Janssen Research & Development, LLC is part of the
Janssen Pharmaceutical Companies. Key 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 the
shortest possible timeframe.
- Involved with site level recruitment strategy and
prioritization 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
detailed.
- 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.
- Aligns 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 be assigned as a coach and mentor to a less experienced
site manager.
- May contribute to process improvement and training.
- Leads and/or participates in special initiatives as
assigned.
- May assume additional responsibilities or special initiatives
such as "Champion" or "Subject Matter Expert". This is not a
comprehensive listing of job functions. May perform other duties as
assigned.
Keywords: Disability Solutions, Edison , Senior Site Manager, Oncology - Southeastern U.S., Healthcare , Raritan, New Jersey
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