Senior Trial Manager Early Development

hace 2 días

Madrid, Madrid, España Johnson And Johnson A tiempo completo
Job Summary

We are seeking a highly skilled and experienced Senior Trial Manager Early Development to join our team at Johnson & Johnson. The successful candidate will be responsible for the local management of trials in one or more countries, acting as the primary point of contact at a country level for assigned studies.

Key Responsibilities
  1. Operational oversight of assigned protocol(s) from start-up to database lock and closeout activities, ensuring compliance with GCP, HCC, SOPs, and local regulatory requirements.
  2. Perform Local Trial Manager (LTM) tasks, including recruitment planning, contingency and risk management, and budget forecasting.
  3. Ensure timely and accurate reporting of Serious Adverse Events (SAE), Product Quality Complaints (PQC), and Suspected Unexpected Serious Adverse Reactions (SUSAR).
  4. Monitor country and overall study progress, initiating corrective and preventive actions when necessary.
  5. Collaborate with the Functional Manager (FM), Program Delivery Leader (PDL), and other study team members to create the final list of sites.
  6. Develop and maintain study management documents, including informed consent forms and country-specific documents.
  7. Lead and coordinate local trial team activities, ensuring compliance with GCO SOPs and other procedural documents.
  8. Act as the primary local contact for the trial, establishing and maintaining excellent working relationships with external stakeholders.
Requirements
  • Minimum of a BA or BS degree in Life Sciences (or equivalent experience).
  • Minimum of 2 years of clinical trial management experience (in addition to site monitoring experience).
  • Previous clinical trial experience in ED&CP is preferred.
  • Strong understanding of the drug development process, including ICH/GCP and local regulatory requirements.
  • Good leadership skills, solid communication, and proficiency in speaking and writing the country language and English language.
  • Ability to work on multiple trials in parallel in different disease areas.
What We Offer

Johnson & Johnson offers a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to diversity and inclusion, and we strive to create a workplace that is welcoming and inclusive for all employees.

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