Senior Local Trial Manager (1 of 3)
Company: Disability Solutions
Location: Raritan
Posted on: October 14, 2024
Job Description:
Johnson and Johnson is currently seeking an Senior Local Trial
Manager. This position can be located remotely within the United
States.At Johnson & Johnson, we believe health is everything. Our
strength in healthcare innovation empowers us to build a world
where complex diseases are prevented, treated, and cured, where
treatments are smarter and less invasive, and solutions are
personal. Through our expertise in Innovative Medicine and MedTech,
we are uniquely positioned to innovate across the full spectrum of
healthcare solutions today to deliver the breakthroughs of
tomorrow, and profoundly impact health for humanity. Learn more at
https://www.jnj.com/. For more than 130 years, diversity, equity &
inclusion (DEI) has been a part of our cultural fabric at Johnson &
Johnson and woven into how we do business every day. Rooted in Our
Credo, the values of DEI fuel our pursuit to create a healthier,
more equitable world. Our diverse workforce and culture of
belonging accelerate innovation to solve the world's most pressing
healthcare challenges.We know that the success of our business -
and our ability to deliver meaningful solutions - depends on how
well we understand and meet the diverse needs of the communities we
serve. Which is why we foster a culture of inclusion and belonging
where all perspectives, abilities and experiences are valued and
our people can reach their potential.At Johnson & Johnson, we all
belong.This role 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 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 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. They will actively contributes to process
improvement; training and mentoring of Clinical Trial Assistants
(CTA), Site Managers (SM) and Associate, Local Trial Managers. The
Senior Local Trial Manager may have some site management
responsibilities. This individual may also perform the role of
Trial Delivery Manager (TDM)/Trial Delivery Leader (TDL) for single
country as described in GCO procedural documents.\rPrimary
responsibilities:\r\r
- \r
- 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 TDM/TDL. Implements any local criteria for site
selection. Ensure consistent conduct of Site Qualification Visits
and instruct teams on appropriate follow-up of Site Qualification
Visit report and country feasibility report. Recommends suitable
sites for selection to participate in trial.
- Collaborates with the Program Delivery Leader (PDL), TDM/TDL,
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 required to 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. Will be
expected to present and lead specific sessions and to facilitate
discussion groups.
- 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 TDM/TDL and FM/CRM 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, SMs and other LTMs.
- May be asked to conducts accompanied site visits with SM as
delegated by FM/CRM. May be required to provide guidance to Assoc
LTMs.
- May assumes additional responsibilities or special initiatives
such as "Champion" or "Subject Matter Expert".
- May represents functional area in process initiatives as
required.\r\r
Keywords: Disability Solutions, Perth Amboy , Senior Local Trial Manager (1 of 3), Executive , Raritan, New Jersey
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