Senior Local Trial Manager (1 of 3)

$103,000 - $165,600/Yr

Johnson & Johnson - Washington, DC

Full-time - Mid Level

Washington, DC

Chemical Manufacturing

About the position

The Senior Local Trial Manager is responsible for the local management of clinical trials in designated countries, ensuring compliance with protocols, SOPs, GCP, and regulatory requirements. This role involves coordinating local trial teams, managing trial activities from start-up to closeout, and contributing to process improvements while 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.
• Lead and coordinate local trial team activities in compliance with SOPs and applicable regulations.
• Ensure timely reporting of Adverse Events and maintain trial management systems.
• Monitor country progress and initiate corrective actions when necessary.
• Assist in negotiation of trial site contracts and manage local trial budget.
• Attend and participate in Investigator Meetings and conduct local trial team meetings.
• Review and approve Monitoring Visit Reports and site invoices.
• Prepare country-specific informed consent and ensure compliance with local regulatory requirements.
• Act as subject matter expert for assigned protocols and maintain relationships with external 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.
• 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.
• 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 insurance.
• Business accident insurance.
• Group legal insurance.
• 401(k) retirement plan.
• 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.