Johnson & Johnson Innovative Medicine · 13 hours ago
Senior Local Trial Manager
United States
Full-time
Remote
Senior Level
$92K/yr - $148K/yr
5+ years expJohnson & Johnson is a leader in healthcare innovation, committed to developing smarter and less invasive treatments. The Senior Local Trial Manager will oversee local clinical trials, ensuring compliance with protocols and regulations while leading the trial team to deliver quality data and documentation.
Pharmaceuticals
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 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 ensures 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
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 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. 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
Qualification
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
Some experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs preferred
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
May be assigned to high priority projects
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
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 Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
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