Lead Local Trial Manager - Immunology

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Remote (US), Spring House, Pennsylvania, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. 

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. 

Learn more at https://www.jnj.com/innovative-medicine

 

About Immunology
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
 

Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Lead, Local Trial Manager- Immunology, to be located remotely in the United States. 

Purpose:

A Lead, Local Trial Manager is considered as a senior trial management role with at least 4 years of clinical trial management experience or more than 6 years of clinical monitoring experience. This role is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries.

The Lead, 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 Lead, 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.

The Lead, Local Trial Manager actively leads or contributes to process improvement; training and mentoring of other LTMs and Site Managers (SM). Compared to Associate, Local Trial Manager and Senior, Local Trial Manager roles, a Lead, Local Trial Manager is often assigned to more complex protocols and can work across Phase 1 – 3 studies in multiple therapeutic areas as needed to drive

business needs. The Lead, Local Trial Manager may also perform the role of Trial Delivery Manager (TDM)/Trial Delivery Leader (TDL) for single country as described in GCO procedural

documents.

What you will be responsible for:

• May be delegated by Functional Manager (FM)/Clinical Research Manager (CRM) to lead country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and TDM/TDL. Implement 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.
• Collaborate 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. May be delegated by study team to initiate document development for global/regional studies.
• 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. Expected to guide Associate LTMs.
• 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. May be required to support Country Heads in generating country performance reports.
• 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. Expected to guide Associate LTMs.

• 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. May be required to be the organizer for Investigator Meetings.
• 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). May be required to provide guidance to Associate LTMs.
• 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. Expected to mentor and guide Associate LTMs.
• Reviews and approves site and local vendor invoices as required. Manages local study supply, as required. Expected to guide Associate LTMs.
• 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. Expected to guide Associate LTMs.
• Organizes and ensures IEC/HA approvals, if applicable, and ensures that the trial is in compliance with local regulatory requirements. Expected to guide Associate LTMs.
• Works with SM to ensure CAPA is implemented for audits and inspection or any quality related visits.
• Comply with relevant training requirements.
• Acts as subject matter expert for assigned protocols. Develop 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 leads or contributes to process improvement, training and mentoring of CTAs, SMs and other LTMs.
• May be asked to conduct accompanied site visits with SM as delegated by FM/CRM. Maybe required to provide guidance to Associate LTMs.
• Expected to assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”.
• Expected to represent functional area or lead country, regional, and global process initiatives as required.

*This is not an exhaustive, comprehensive listing of job functions. May perform other duties as

assigned.

Requirements / Qualifications:

• A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences, or related scientific field is required.
• Minimum of 6 years of clinical trial management experience or a total of at least 8 years of clinical trial monitoring and/or clinical trial management experience. However, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
• Minimum of 4 years of leadership experience.
• Immunology therapeutic experience is highly desirable, with specific expertise in gastrointestinal, rheumatologic, dermatologic, and respiratory indications preferred.
• Should have an in-depth understanding of the drug development process including GCP and local regulatory requirements.
• Approximately 10% travel is required, including occasional overnight stays away from home.
• Computer skills required.
• Proficient in speaking and writing the country language and English language.
• Excellent written and oral communication skills.
• Demonstrated ability to be consistently influential.
• Strong experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs.
• Demonstrated 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 in different disease areas, if required.
• Ability to anticipate obstacles and proactively provide solutions.
• Expected to be assigned to high priority and high complexity projects.

The anticipated base pay range for this position in the US is $109,000 - $174,800. The anticipated base pay range for the Bay Area is $125,000 - $201,250.  

The Company maintains highly competitive, performance-based compensation programs.  Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.  The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year.  Bonuses are awarded at the Company’s discretion on an individual basis. 

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. 

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). 

Employees are eligible for the following time off benefits: 

• 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

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits 

This job posting is anticipated to close on June 5th, 2026. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications. 

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)