SENIOR CLINICAL TRIAL MANAGER
AbbVie
Full-timesenior
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Job description
<ul><li>Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).</li><li>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</li><li>Supports the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR)</li><li>Supports the vendor selection, scope development, management and oversight of external vendors in compliance with AbbVie’s processes and procedures and the applicable regulations.</li><li>Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies</li><li>Proactively identify and resolve and/or escalate study related issues</li><li>Participates in process improvement initiatives</li></ul>
<ul><li>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.</li><li>Must have at least four years of Pharma-related/clinical research related experience and demonstrated a high level of core and technical competencies.</li><li>Possesses good communication skills.</li><li>Competent in application of standard business procedures {Standard operating procedures, International Conference on Harmonization {ICH), Global Regulations, Ethics and Compliance).</li><li>Preferred exposure to study initiation through study completion.</li><li>At least 3 years in clinical trial management positions.</li><li>Fluent in English (C1)</li><li>Remote position based in Madrid.</li></ul>
<div sr-tagline=""></div><p>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. </p><p>US & Puerto Rico only - to learn more, visit <a href="https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html" rel="noopener noreferrer">https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html</a></p><p>US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:</p><p><a href="https://www.abbvie.com/join-us/reasonable-accommodations.html" rel="noopener noreferrer">https://www.abbvie.com/join-us/reasonable-accommodations.html</a></p>