Senior Local Trial Manager - Immunology (1 of 3)
Company: Disability Solutions
Location: Raritan
Posted on: May 6, 2024
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Job Description:
Johnson & Johnson Innovative Medicine is recruiting for a Senior
Local Trial Manager - Immunology . This position can be located
remotely within the United States. The Senior Local Trial Manager
(Sr. LTM) is responsible for local management of a clinical trial
(or Medical Affairs data generation activity) in a country or
countries. The Senior Local Trial Manager (Sr. LTM) is the primary
point of contact at a country level for assigned studies and has
operational oversight of assigned protocol(s) from start-up through
to database lock and closeout activities as described in GCO
procedural documents. The Senior Local Trial Manager (Sr. LTM) is
responsible for coordinating and leading the local trial team to
deliver quality data and trial documents/records that are compliant
with the assigned clinical trial protocol, company Standard
Operating Procedures (SOPs), Good Clinical Practice (GCP), and
regulatory requirements. The Senior Local Trial Manager (Sr. LTM)
actively contributes to process improvement; training and mentoring
of Clinical Trial Assistants (CTA), Site Managers (SM) and LTM I
roles. The Senior Local Trial Manager (Sr. LTM) may have some site
management responsibilities. The Senior Local Trial Manager (Sr.
LTM) may also perform the role of Clinical Trial Manager
(CTM)/Global Trial Lead (GTL) for single country as described in
GCO procedural documents. At Johnson & Johnson Innovative Medicine,
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 Johnson & Johnson
Innovative Medicine. We collaborate with the world for the health
of everyone in it. Responsibilities: --- Collaborate with
Functional Manager (FM)/Clinical Research Manager (CRM) for country
protocol feasibility (if applicable) and site feasibility
assessment in conjunction with CTA (if applicable), SM and CTM/GTL.
Implements any local criteria for site selection. Ensure consistent
conduct of pre-trial assessment visits and instruct teams on
appropriate follow-up of pre-trial visit report and country
feasibility report. Recommends suitable sites for selection to
participate in trial. --- Collaborates with the Global Product Lead
(GPL), CTM/GTL, local management/Country Head and other study team
member to select final site list. --- Contributes input to the
study management documents at a country level or initiates
development of these documents for a single country trial, as per
SOPs. --- Leads and coordinates local trial team activities in
compliance with SOPs, other procedural documents, and applicable
regulations. Leads local project planning activities to meet
recruitment targets and to deliver high quality data on time and
within study budget. Including but not limited to: development of
local trial specific procedures and tools, recruitment planning,
contingency and risk management, and budget forecasting. ---
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. ---
Maintains and updates trial management systems. Uses study tools
and management reports available to analyze trial progress. ---
Monitors country progress and initiates corrective and preventive
actions (CAPA) when the trial deviates from plans and communicates
study progress and issues to study management teams. --- May submit
requests for vendor services and may support vendor selection. ---
In certain situations, may assist in negotiation of trial site
contracts and budgets. Forecasts and manages country/local trial
budget to ensure accurate finance reporting and trial delivered
-within budget. Adheres to finance reporting deliverables and
timelines. --- Attends/participates in Investigator Meetings as
needed. May schedule and conduct a local/country investigator
meeting. --- Conducts local trial team meetings and provides or
facilitates SM training when needed (i.e. implementation of study
amendment-and changes in study related processes). --- Reviews and
approves Monitoring Visit Reports submitted by SM; identifies
issues and/or trends across a trial project and escalates deviation
issues to the CTM/GTL and FM as needed. --- Reviews and approves
site and local vendor invoices as required. Manages local study
supply, as required. --- Prepares country specific informed consent
in accordance with procedural document/templates. Reviews and
manages site specific informed consent forms in accordance with
SOPs, other procedural documents, and applicable regulations. ---
Organizes and ensures IEC/HA approvals, if applicable, and ensure
that the trial is in compliance with local regulatory requirements.
--- Works with SM to ensure CAPA is implemented for audits and
inspection or any quality related visits. --- Complies with
relevant training requirements. --- Acts as subject matter expert
for assigned protocols. Develops strong therapeutic knowledge to
support roles and responsibilities. May represent GCO on cross
functional teams. --- Acts as primary local/country contact for a
trial. Establishes and maintains excellent working relationships
with external stakeholders, in particular investigators, study
trial coordinators and other site staff; and internal stakeholders,
including Medical Affairs and Marketing for Medical Affairs trials.
--- Actively contributes to process improvement, training and
mentoring of CTAs, SM and other LTMs. --- Conducts accompanied site
visits with SM as delegated by FM. --- May assumes additional
responsibilities or special initiatives such as "Champion" or
"Subject Matter Expert". --- May represents functional area in
process initiatives as required.
Keywords: Disability Solutions, Bridgeport , Senior Local Trial Manager - Immunology (1 of 3), Executive , Raritan, Connecticut
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