Johnson & Johnson

Senior Local Trial Manager, Immunology

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: Spring House • Pennsylvania • 🇺🇸 United States

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Salary

💰 $89,000 - $143,750 per year

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • 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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical trial managementclinical trial monitoringdrug development processGCPsite qualificationbudget forecastingrisk managementadverse event reportingtrial management systemsSOPs
Soft skills
leadershipcommunicationmentoringcoachinginfluentialflexibilityproblem-solvingteam leadershiporganizationaladaptability
Certifications
BA or BS degree in PharmacyBA or BS degree in NursingBA or BS degree in Life Sciences