Senior Local Trial Manager (1 of 3)

$103,000 - $165,600/Yr

Johnson & Johnson - Trenton, NJ

Full-time - Mid Level

Trenton, NJ

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 coordinates local trial teams to ensure compliance with clinical trial protocols, company SOPs, GCP, and regulatory requirements, while also contributing to process improvements and mentoring junior staff.

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, communicating issues to study management teams.
• Assist in negotiation of trial site contracts and budgets, managing local trial budgets accurately.
• Conduct local trial team meetings and provide training to Site Managers as needed.
• Review and approve Monitoring Visit Reports and site invoices, managing local study supplies as required.
• Prepare country-specific informed consent forms and ensure compliance with local regulatory requirements.
• Act as the primary local contact for a trial, establishing 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.
• Experience in the oncology therapeutic area.
• Good understanding of the drug development process, including GCP and local regulatory requirements.
• Experience with clinical research applications (CTMS, TMF, EDC, etc.).
• Ability to work on multiple trials in parallel and anticipate obstacles.
• Excellent written and oral communication skills.
• Flexible mindset and ability to work in a fast-changing environment.
• Willingness to travel with occasional overnight stays.

Nice-to-haves

• Experience in mentoring/coaching and providing training to other Local Trial Managers, Site Managers, and Clinical Trial Assistants.

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)