About the role
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 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.
At least 3 years in clinical trial management positions.
Fluent in English (C1)
Remote position based in Madrid.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn,Facebook, Instagram, X and YouTube.
Originally posted on Himalayas