Senior Clinical Trial Manager
- Madrid
- Permanente
- Tiempo completo
- Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
- Supports the Study Project Manager in leading the cross functional study team: o -Supports the preparation of Clinical Study Team meetings (Agenda/Minutes) o -Responsible for regular updates to the cross-functional team and stakeholders on study status; ensure our CTMS is up to date
- Supports the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR)
- Supports the vendor selection, scope development, management and oversight of external vendors in compliance with AbbVie's processes and procedures and the applicable regulations.
- Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies
- Proactively identify and resolve and/or escalate study related issues
- Participates in process improvement initiatives.
- Bachelor's Degree or OUS equivalent scientific degree required.
- Must have at least four years of Pharma-related/clinical research related experience and demonstrated a high level of core and technical competencies as a Clinical Trial Manager
- Possesses good communication skills in both English and Spanish.
- Competent in application of standard business procedures {Standard operating procedures, International Conference on Harmonization {ICH), Global Regulations, Ethics and Compliance).
- Preferred exposure to study initiation through study completion.