Senior Local Trial Manager (1 of 3)

$103,000 - $165,600/Yr

Johnson & Johnson - Boston, MA

Full-time - Mid Level

Boston, MA

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 ensures compliance with clinical trial protocols, company SOPs, GCP, and regulatory requirements while leading the local trial team to deliver quality data and documentation. Additionally, this position involves mentoring junior staff and contributing to process improvements.

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.
• Lead and coordinate local trial team activities in compliance with SOPs and applicable regulations.
• Monitor country progress and initiate corrective actions when the trial deviates from plans.
• Forecast and manage country/local trial budget to ensure accurate finance reporting.
• Attend and participate in Investigator Meetings as needed, presenting and facilitating discussions.
• Prepare country-specific informed consent in accordance with procedural documents.
• Act as the primary local/country contact for a trial, establishing 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.
• 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.).
• 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, 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.