Vacancy caducado!
Janssen
Research & Development, LLC, a member of Johnson & Johnson's Family of
Companies, is recruiting for a Senior Local Trial Manager supporting the
Oncology, Medical Affairs and Pulmonary Arterial Hypertension Therapeutic
Areas. 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, and cardiovascular and
metabolic diseases. Please visit
http://www.JanssenRnD.com for more information.The
Senior Local Trial Manager (Senior LTM) will be responsible for local
management of a clinical trial (or Medical Affairs data generation activity) in
a country or countries. This individual
will be 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 Global Clinical
Operations (GCO) procedural documents. Coordinate
and lead 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. This role may include some
site management responsibilities and may also perform the role of Clinical
Trial Manager (CTM)/Global Trial Leader (GTL) for single country as described
in GCO procedural documents.Principal
Responsibilities:
Collaborate
with Functional Manager (FM)/Clinical Research Manager (CRM) and Feasibility Process Leader or Global Feasibility Leader
(GFL) for country protocol feasibility (if applicable) and site feasibility
assessment in conjunction with the Clinical Trial Assistant (CTA) (if
applicable), Site Manager (SM) and CTM/GTL. Implement 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. Recommend suitable sites for selection to
participate in trial.
Collaborate
with Global Program Leader (GPL), CTM/GTL, local management/Country Head and
other study team member to select final site list.
Contribute
input to the study management documents at a country level or initiates
development of these documents for a single country trial, as per SOPs
Lead
and coordinate local trial team activities in compliance with SOPs, other
procedural documents and applicable regulations. Lead 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.
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.
Maintain
and update trial management systems. Use
study tools and management reports available to analyze trial progress.
Monitor
country progress and initiate Corrective and Preventive Action (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. Forecast and manage
country/local trial budget to ensure accurate finance reporting and trial
delivered within budget. Adhere to
finance reporting deliverables and timelines.
Attend/participate
in Investigator Meetings as needed. May
schedule and conduct a local/country investigator meeting.
Conduct
local trial team meetings and provide or facilitate SM training when needed
(i.e. implementation of study amendment-and changes in study related
processes).
Review
and approve Monitoring Visit Reports submitted by SM and identify issues and/or
trends across a trial project and escalates deviation issues to the CTM/GTL and
Functional Manager (FM), as needed
Review
and approve site and local vendor invoices as required. Manage local study supply, as required.
Prepare
country specific informed consent in accordance with procedural
document/templates. Review and manage
site specific informed consent forms in accordance with SOPs, other procedural
documents and applicable regulations.
Organize
and ensure Independent Ethics Committee (IEC)/Health
Authority (HA) approvals, if applicable, and ensure that the trial is in
compliance with local regulatory requirements.
Work
with SM to ensure CAPA is implemented for audits and inspection or any quality
related visits.
Comply
with relevant training requirements.
Act
as subject matter expert for assigned protocols. Develop strong therapeutic knowledge to
support roles and responsibilities. May represent
GCO on cross functional teams.
Act
as primary local/country contact for a trial. Establish and maintain 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
contribute to process improvement, training and mentoring of CTAs, SMs and
other LTMs.
Conduct
accompanied site visits with SM as delegated by FM.
May
assume additional responsibilities or special initiatives such as “Champion” or
“Subject Matter Expert”.
May
represent functional area in process initiatives as required.
Qualifications
A
minimum of an Associate’s degree or completion of a Nursing Program (RN) is
required. A Bachelor’s degree in a
Health or Science discipline is preferred.
A
minimum of 2 years of pharmaceutical industry and/or clinical trial experience
is required.
Clinical
operations experience is preferred.
Experience
in the Oncology Therapeutic Area required.
Experience
in the Medical Affairs and Arterial Pulmonary Hypertension Therapeutic Areas
preferred.
Knowledge
of the drug development process, including Good Clinical Practices (GCPs) and
FDA Code of Federal Regulations, is required.
Project
management experience is preferred.
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 oral communication skills.
Must
have solid leadership skills.
Must
have a flexible mindset with the ability to work in a fast-changing
environment.
The
ability to work on multiple trials in parallel is preferred.
The
ability to lead initiative/small teams is preferred.
Minimal
business travel (meetings, training, etc.) is required.
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 LocationUnited States-New Jersey-Raritan-Other LocationsNorth America-United StatesOrganizationJanssen Research & Development, LLC (6084)Job FunctionClinical Trial AdministrationRequisition ID4182190917