Johnson & Johnson - Nashville, TN

posted 13 days ago

Full-time - Mid Level
Nashville, TN
Chemical Manufacturing

About the position

The Senior Local Trial Manager at Johnson & Johnson is responsible for the local management of clinical trials, ensuring compliance with protocols, SOPs, GCP, and regulatory requirements. This role involves operational oversight from trial start-up to database lock and closeout, coordinating local trial teams, and contributing to process improvements. The position requires strong leadership and communication skills, as well as the ability to manage multiple trials simultaneously.

Responsibilities

  • Collaborate with Functional Manager and Clinical Research Manager for country protocol feasibility and site feasibility assessment.
  • Lead and coordinate local trial team activities in compliance with SOPs and applicable regulations.
  • Ensure all Adverse Events and Serious Adverse Events are reported within required timelines.
  • Maintain and update trial management systems, analyzing trial progress using available tools.
  • Monitor country progress and initiate corrective actions when necessary.
  • Assist in negotiation of trial site contracts and budgets, managing local trial budget accurately.
  • Conduct local trial team meetings and provide training as needed.
  • Review and approve Monitoring Visit Reports and site invoices as required.
  • Prepare country-specific informed consent in accordance with procedural documents.
  • Establish and maintain excellent working relationships with external and internal stakeholders.

Requirements

  • Bachelor's degree in Pharmacy, Nursing, Life Sciences, or related scientific field.
  • Minimum of 2 years of clinical trial management experience or 5 years of clinical trial monitoring/management experience.
  • Minimum of 2 years of leadership experience.
  • Oncology therapeutic area experience.
  • Good understanding of the drug development process, including GCP and local regulatory requirements.
  • Experience with clinical research applications (CTMS, TMF, EDC, etc.).
  • Excellent written and oral communication skills.
  • Ability to work on multiple trials in parallel and anticipate obstacles.

Nice-to-haves

  • Experience in mentoring/coaching and providing training to other LTMs, SMs, and CTAs.

Benefits

  • Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
  • 401(k) retirement plan and savings plan participation.
  • Vacation - up to 120 hours per calendar year.
  • Sick time - up to 40 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.
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