Johnson & Johnson - Columbus, OH

posted 13 days ago

Full-time - Mid Level
Columbus, OH
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 coordinating local trial teams, overseeing trial activities from start-up to closeout, 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.
  • Monitor country progress and initiate corrective actions when necessary.
  • Prepare country-specific informed consent in accordance with procedural documents.
  • Conduct local trial team meetings and provide training as needed.
  • Act as primary local contact for a trial and maintain relationships with external and internal stakeholders.

Requirements

  • Bachelor's degree in Pharmacy, Nursing, Life Sciences, or related 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.

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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