Hybrid Senior Local Trial Manager, Immunology

at Johnson & Johnson

• Job title: Senior Local Trial Manager, Immunology
• Job type: Full Time
• Experience level: Senior
• Salary: $89,000 - $143,750 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Spring House, United States

About the role

• Senior Local Trial Manager in Immunology at Johnson & Johnson. Overseeing clinical trials and ensuring compliance while mentoring local teams.

Responsibilities

• Collaborates with Functional Manager (FM) 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.
• Ensures 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 members 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.

Requirements

• 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.
• 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.
• Some experience in mentoring/coaching and providing training to other LTMs, SMs, and CTAs preferred.
• 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.

Benefits

• medical
• dental
• vision
• life insurance
• short- and long-term disability
• business accident insurance
• 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