Lead Local Trial Manager
Johnson & Johnson
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Job Function:
R&D OperationsJob Sub Function:
Clinical Trial Project ManagementJob Category:
ProfessionalAll Job Posting Locations:
Kibbutz Shefayim, Center District, IsraelJob Description:
We are seeking an experienced Lead Local Trial Manager (LTM) to oversee and drive the successful execution of clinical trials at the country level. This senior role is ideal for candidates with strong leadership capabilities, deep understanding of clinical operations, and proven experience in trial management or monitoring.
As a Lead LTM, you will serve as the primary point of contact in the country for assigned studies, managing trials from start-up through close-out, ensuring operational excellence, compliance, and high-quality data delivery. You will lead local trial teams, collaborate with global stakeholders, and contribute to process improvement initiatives.
Key Responsibilities
Trial Leadership & Oversight
- Lead local management of clinical trials from start-up to database lock and closeout.
- Serve as the primary local contact for assigned studies.
- Coordinate and guide local trial teams to meet recruitment goals, timelines, quality standards, and budget expectations.
- Drive planning activities including local procedures, recruitment forecasting, risk management, and contingency plans.
Site & Country Management
- Lead country-level feasibility assessments and support site selection.
- Oversee consistent conduct of Site Qualification Visits and review feasibility outputs.
- Ensure timely reporting of AEs/SAEs/PQCs according to regulations and SOPs.
- Maintain study systems and utilize reporting tools to monitor progress.
Quality, Compliance & Documentation
- Ensure compliance with protocol, SOPs, GCP, and regulatory requirements.
- Review and approve Monitoring Visit Reports; identify trends and ensure escalation when needed.
- Prepare and manage country-specific and site-specific informed consent forms.
- Oversee submissions to ethics committees/health authorities and ensure regulatory compliance.
Vendor, Budget & Contract Management
- Support vendor selection and service requests.
- Assist in negotiation of site contracts and oversee local study budgets.
- Review and approve local vendor and site invoices.
Training, Mentoring & Stakeholder Engagement
- Provide training, guidance, and mentorship to Associate LTMs, Site Managers (SMs), and CTAs.
- Represent the local team at Investigator Meetings and lead selected presentations/sessions.
- Build and maintain strong relationships with investigators, site staff, Medical Affairs, and internal partners.
Strategic Initiatives
- Act as subject matter expert for assigned protocols.
- Contribute to process improvements, global/regional initiatives, and cross-functional teams.
- May conduct accompanied site visits and lead special country/regional projects.
Requirements
- Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or related scientific field (or equivalent experience).
- Minimum 6 years of clinical trial management experience
OR at least 8 years of combined clinical monitoring and trial management experience. - At least 4 years of leadership experience, including coaching and mentoring.
- Strong therapeutic area expertise and in-depth understanding of drug development, GCP, and local regulatory requirements.
- Excellent communication skills in both English and the local language.
- Ability to work in a dynamic environment and manage multiple trials simultaneously.
- Proven ability to anticipate challenges and proactively propose solutions.
- Willingness to travel, including occasional overnight stays.
- High proficiency with digital tools and trial management systems.
Required Skills:
Preferred Skills:
Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)