Clinical Trial Manager

Clinical Trial Manager

AbbVie

Madrid, Spain

Job Description

• 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:
  • Supports the preparation of Clinical Study Team meetings (Agenda/Minutes);
  • 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.

Qualifications

• Bachelor’s Degree or OUS equivalent degree required, typically in nursing or scientific field; Registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is also acceptable;
• Must have at least four years of Pharma-related/clinical research related experience and demonstrated a high level of core and technical competencies.
• Possesses good communication skills;
• 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.