Senior Local Trial Manager (1 of 3)

$103,000 - $165,600/Yr

Johnson & Johnson - Madison, WI

Full-time - Mid Level

Madison, WI

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.
• 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.
• Manage local study supply and review site and local vendor invoices as required.
• Prepare country-specific informed consent in accordance with procedural documents.
• Act as primary local contact for a trial and maintain relationships with external and internal stakeholders.
• Conduct local trial team meetings and provide training as needed.

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.

Nice-to-haves

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

Benefits

• Medical insurance
• Dental insurance
• 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