Senior Local Trial Manager (1 of 3)

$103,000 - $165,600/Yr

Johnson & Johnson - Indianapolis, IN

Full-time - Mid Level

Indianapolis, IN

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 involves operational oversight from trial start-up to database lock and closeout, ensuring compliance with clinical trial protocols, company SOPs, GCP, and regulatory requirements. The Senior Local Trial Manager coordinates the local trial team, contributes to process improvements, and may also take on site management responsibilities.

Responsibilities

• Collaborate with Functional Manager and Clinical Research Manager for country protocol feasibility and site feasibility assessment.
• Ensure consistent conduct of Site Qualification Visits and instruct teams on appropriate follow-up of reports.
• Recommend suitable sites for selection to participate in trials.
• 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.
• Monitor country progress and initiate corrective and preventive actions when the trial deviates from plans.
• Attend and participate in Investigator Meetings as needed, and may conduct local investigator meetings.
• Review and approve Monitoring Visit Reports and site/vendor 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 at least 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.).
• Ability to work on multiple trials in parallel.
• Excellent written and oral communication skills.
• Flexible mindset and ability to work in a fast-changing environment.

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 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.