Senior Clinical Trial Manager

Role Summary

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.

About the Company

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 www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

R&D Process Engineering Organization, a part of AbbVie’s Development Sciences organization, is responsible for designing and developing scalable processes to make drug substances and drug products, including synthetics molecules, antibody drug conjugates (ADCs) and genetic medicines, throughout pre-clinical and clinical development stages. Process Engineering also partners with Biologics CMC (Chemistry, Manufacturing, and Controls) Development and Aesthetics R&D functions to provide active engineering support to enable robust process scale-up and manufacturing of biologics drug substances and drug products including toxins and cosmetic active ingredients (CAIs). It drives the development of innovative engineering technologies and creates valuable intellectual property through the composition of matter and chemical/bio-chemical processes resulting in cost-effective commercial manufacturing processes for quality products.