Lead Local Trial Manager (Madrid)

Lead Local Trial Manager (Madrid)

04 sep
|
Johnson u0026 Johnson
|
Madrid

04 sep

Johnson u0026 Johnson

Madrid

Experteer Overview
In this role you drive local trial management for clinical studies, ensuring data quality and regulatory compliance from start-up to closeout. You lead country-level trial teams, coordinate with cross-functional partners, and implement process improvements to meet timelines and budgets. You will develop local procedures, mentor LTMs and SMs, and represent GCO on cross-functional initiatives. This is a senior, impact-facing position in a fast-changing, general environment with a focus on complex protocols across phases 1–3.

Compensaciones / Beneficios
• Lead country protocol feasibility and site selection processes with CTA/SM/TDM/TDL
• Collaborate with Program Delivery Leader and study team to finalize site lists
• Contribute to or initiate country-specific study management documents per SOPs
• Oversee local trial planning to meet recruitment targets, quality data, and budget
• Ensure timely reporting of AE/SAE/PQC incidents and proper documentation
• Maintain and analyze trial management systems and generate country performance reports
• Monitor progress and implement CAPA for deviations; communicate with study teams
• Support vendor selection and, if needed, negotiate site contracts/budgets
• Forecast and manage country/local trial budgets and ensure finance reporting
• Lead Investigator Meetings and present sessions as required
• Organize local team meetings and provide SM training on amendments/process changes
• Review Monitoring Visit Reports; mentor Associate LTMs and address issues
• Approve site and vendor invoices; manage local study supplies




• Prepare country-specific informed consent and oversee site approvals
• Ensure IEC/HA approvals and local regulatory compliance
• Work with SM to ensure CAPA for audits/inspections
• Maintain required training and act as subject matter expert for protocols
• Establish strong relationships with investigators, staff, and internal stakeholders
• Lead process improvements and mentor LTMs/CTAs; participate in accompanied site visits as needed
• Represent the function in country, regional, and global process initiatives
• Perform other duties as assigned

Responsabilidades
• BA/BS in Pharmacy, Nursing, Life Sciences or related field
• Minimum 6 years of clinical trial management or 8+ years of monitoring/management experience
• Demonstrated AI literacy and ability to apply AI tools to improve productivity and outcomes
• Therapeutic area experience and solid understanding of drug development, GCP, and local regulations
• Willingness to travel with occasional overnight stays
• Minimum 4 years of leadership experience
• Strong computer skills and proficiency in country language and English
• Excellent written and oral communication; influential and able to mentor others
• Ability to lead initiatives, manage multiple trials in parallel, and adapt to fast-changing environments
• Ability to anticipate obstacles and provide proactive solutions
• Experience with vendor management and budget forecasting

Requisitos principales
• annual bonus
• vacation days
• parental leave
• well-being reimbursement
• insurance plans
• recognition awards

📌 Lead Local Trial Manager (Madrid)
🏢 Johnson u0026 Johnson
📍 Madrid

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