Johnson & Johnson - Albany, NY

posted 13 days ago

Full-time - Mid Level
Albany, NY
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 position emphasizes compliance with clinical trial protocols, company SOPs, GCP, and regulatory requirements, while also focusing on quality data delivery and trial documentation. The Senior Local Trial Manager will lead a local trial team, contribute to process improvements, and mentor junior staff, ensuring effective trial execution and adherence to timelines and budgets.

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.
  • Recommend suitable sites for selection to participate in trials.
  • Collaborate with the Program Delivery Leader and other team members to select the final site list.
  • Contribute input to study management documents at a country level or initiate development for single country trials.
  • Lead and coordinate local trial team activities in compliance with SOPs and applicable regulations.
  • Plan local project activities to meet recruitment targets and deliver high-quality data on time and within budget.

Requirements

  • Experience in clinical trial management or related field.
  • Strong understanding of Good Clinical Practice (GCP) and regulatory requirements.
  • Proven ability to lead and coordinate teams effectively.
  • Excellent communication and interpersonal skills.

Nice-to-haves

  • Experience with site management responsibilities.
  • Familiarity with clinical trial protocols and documentation processes.

Benefits

  • Comprehensive health insurance coverage.
  • 401k retirement savings plan with matching contributions.
  • Paid time off and holidays.
  • Opportunities for professional development and training.
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