05 sep
|
Johnson u0026 Johnson
|
Madrid
05 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, global environment with a focus on complex protocols across phases 1–3.Compensaciones / Ventajas
- 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 assignedResponsabilidades
- 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 tomentor 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 forecastingRequisitos principales
- annual bonus
- vacation days
- parental leave
- well-being reimbursement
- insurance plans
- recognition awards
📌 Lead Local Trial Manager (Madrid)
🏢 Johnson u0026 Johnson
📍 Madrid