Johnson & Johnson · 5 hours ago
Senior Local Trial Manager, Immunology
Raritan, NJ
Full-time
Remote
Mid, Senior Level
$89K/yr - $144K/yr
2+ years exp
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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 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 analyse 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. This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
Qualification
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Required
A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences or related scientific field is required.
Minimum of 2 years of clinical trial management experience or a total of at least 5 years of clinical trial monitoring and/or clinical trial management experience.
Specific therapeutic area experience may be required depending on the position.
Should have a good understanding of the drug development process including GCP and local regulatory requirements.
Willingness to travel with occasional overnight stay away from home.
Minimum of 2 years of leadership experience.
Computer skills required.
Proficient in speaking and writing the country language and English language.
Excellent written and oral communication skills.
Demonstrated potential to be influential.
The ability to lead initiative/small teams.
Flexible mindset and ability to work in a fast-changing environment.
Ability to work on multiple trials in parallel.
Ability to anticipate obstacles and proactively provide solutions.
Preferred
Some experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs preferred.
Benefits
Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Company
Johnson & Johnson
Johnson & Johnson develops medical devices, pharmaceuticals, and consumer packaged goods.
10,001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (43)
2022 (55)
2021 (40)
2020 (30)
Funding
Current Stage
Public CompanyTotal Funding
unknown1944-09-24IPO· undefined
Leadership Team
Alex Gorsky
Chairman & CEO
Joaquin Duato
Chairman of the Board & CEO
Recent News
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2024-11-24
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2024-11-24
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