Senior Local Trial Manager (1 of 3)

$103,000 - $165,600/Yr

Johnson & Johnson - Providence, RI

Full-time - Mid Level

Providence, RI

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.
• Implement local criteria for site selection and ensure consistent conduct of Site Qualification Visits.
• Contribute input to study management documents at a country level and lead local trial team activities in compliance with SOPs.
• Monitor country progress and initiate corrective actions when the trial deviates from plans.
• Manage local study budget and ensure accurate finance reporting.
• Attend and participate in Investigator Meetings and conduct local trial team meetings.
• Review and approve Monitoring Visit Reports and site/vendor invoices as required.
• Prepare country-specific informed consent and ensure compliance with local regulatory requirements.

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.

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; up to 56 hours for Washington residents.
• Holiday pay, including Floating Holidays - up to 13 days per calendar year.
• Work, Personal and Family Time - up to 40 hours per calendar year.