Senior Local Trial Manager (1 of 3)

$103,000 - $165,600/Yr

Johnson & Johnson - Montgomery, AL

Full-time - Mid Level

Montgomery, AL

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 database lock and closeout, coordinating local trial teams, and contributing to process improvements. The position requires collaboration with various stakeholders to ensure high-quality data delivery and adherence to timelines and budgets.

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.
• 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.
• 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 LTMs, SMs, and CTAs.

Benefits

• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• 401(k) retirement plan and savings plan participation.
• Vacation - up to 120 hours per calendar year.
• Sick time - up to 40 hours per calendar year.
• Holiday pay, including Floating Holidays - up to 13 days per calendar year.
• Work, Personal and Family Time - up to 40 hours per calendar year.