Senior Local Trial Manager (1 of 3)

$103,000 - $165,600/Yr

Johnson & Johnson - Columbia, SC

Full-time - Mid Level

Columbia, SC

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 the local trial team 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 and analyze trial progress using available tools.
• Monitor country progress and initiate corrective actions when necessary.
• Assist in negotiation of trial site contracts and budgets, managing local trial budgets accurately.
• 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.
• 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.).
• Excellent written and oral communication skills.
• Ability to work on multiple trials in parallel and anticipate obstacles.

Nice-to-haves

• Experience in mentoring/coaching and providing training to other LTMs, SMs, and CTAs.

Benefits

• Medical, dental, and 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 including floating holidays up to 13 days per year
• Work, personal, and family time up to 40 hours per year