Johnson & Johnson - Boise, ID

posted 13 days ago

Full-time - Mid Level
Boise, ID
Chemical Manufacturing

About the position

The Senior Local Trial Manager at Johnson & Johnson is responsible for the local management of clinical trials or Medical Affairs data generation activities within a specified country or countries. This role serves as the primary point of contact for assigned studies, overseeing operational aspects from start-up to database lock and closeout. The Senior Local Trial Manager ensures compliance with clinical trial protocols, company SOPs, GCP, and regulatory requirements while leading the local trial team to deliver quality data and documentation. Additionally, this position involves mentoring junior staff and contributing to process improvements.

Responsibilities

  • Collaborate with Functional Manager and Clinical Research Manager for country protocol feasibility and site feasibility assessment.
  • Implement local criteria for site selection and ensure consistent conduct of Site Qualification Visits.
  • Lead and coordinate local trial team activities in compliance with SOPs and applicable regulations.
  • Monitor country progress and initiate corrective actions when the trial deviates from plans.
  • Manage local study budget and ensure accurate finance reporting.
  • 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.

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 up to 13 days per year
  • Work, Personal and Family Time up to 40 hours per year
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