Senior Trial Manager Early Development
hace 2 días
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- 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.
- Perform Local Trial Manager (LTM) tasks, including recruitment planning, contingency and risk management, and budget forecasting.
- Ensure timely and accurate reporting of Serious Adverse Events (SAE), Product Quality Complaints (PQC), and Suspected Unexpected Serious Adverse Reactions (SUSAR).
- Monitor country and overall study progress, initiating corrective and preventive actions when necessary.
- Collaborate with the Functional Manager (FM), Program Delivery Leader (PDL), and other study team members to create the final list of sites.
- Develop and maintain study management documents, including informed consent forms and country-specific documents.
- Lead and coordinate local trial team activities, ensuring compliance with GCO SOPs and other procedural documents.
- Act as the primary local contact for the trial, establishing and maintaining excellent working relationships with external stakeholders.
- 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.
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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