Johnson & Johnson - Raritan, NJ

posted 14 days ago

Full-time - Mid Level
Raritan, NJ
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 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.
  • Ensure consistent conduct of Site Qualification Visits and instruct teams on appropriate follow-up actions.
  • Recommend suitable sites for selection to participate in trials.
  • Contribute input to study management documents at a country level and initiate development for single country trials.
  • Lead and coordinate local trial team activities in compliance with SOPs and applicable regulations.
  • Monitor country progress and initiate corrective actions when necessary.
  • Manage local trial budget and ensure accurate finance reporting.
  • Attend and participate in Investigator Meetings as needed.
  • Conduct local trial team meetings and provide training when needed.
  • Review and approve Monitoring Visit Reports and site/vendor invoices as required.

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.
  • Flexible mindset and ability to work in a fast-changing environment.

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 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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