Johnson & Johnson - Lansing, MI

posted 13 days ago

Full-time - Mid Level
Lansing, MI
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.
  • 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 budgets 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 insurance
  • Dental insurance
  • Vision insurance
  • Life insurance
  • Short- and long-term disability insurance
  • Business accident insurance
  • Group legal insurance
  • 401(k) retirement plan
  • Vacation time up to 120 hours per year
  • Sick time up to 40 hours per year
  • Holiday pay including Floating Holidays up to 13 days per year
  • Work, Personal and Family Time up to 40 hours per year
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