Senior Clinical Trial Manager

ABBVIE; Madrid; Híbrido; EUR 48.000 - 72.000; Jornada completa

Descripción de la vacante

AbbVie seeks a qualified professional to execute and support clinical studies from Madrid in a remote capacity. The role requires SOP/ICH knowledge, regulatory compliance, and collaboration with cross-functional teams to ensure quality study conduct.

Candidates should have 4+ years in pharma-related research and at least 3 years in trial management, with RN or science background. This position is based in Madrid and offers remote work within Spain.

Formación

• Bachelor’s degree or equivalent in nursing or scientific field.
• RN licensure with ADN with relevant experience acceptable.
• At least four years in pharma-related/clinical research.
• Experience with SOPs, ICH, global regulations, ethics and compliance.
• Preferred exposure from initiation to study completion.
• ≥3 years in clinical trial management.

Responsabilidades

• Execute elements of clinical studies in compliance with quality standards (ICH/GCP, global regulations, AbbVie policies).
• Support Study Project Manager in leading cross-functional study team; prepare agendas/minutes; update study status and CTMS.
• Assist development of study blueprint/protocol and documents (informed consent forms, eCRFs, IRT, CSR).
• Assist vendor selection, scope development, management and oversight of external vendors per AbbVie processes.
• Generate study-related training for study team, sites and vendors.
• Identify and resolve or escalate study-related issues proactively.
• Participate in process improvement initiatives.

Conocimientos

Pharma/clinical research

Clinical study management

Regulatory compliance

GCP/ICH knowledge

Educación

Bachelor’s degree

Nursing license

Herramientas

CTMS experience

eCRF systems

Descripción del empleo

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 atwww.abbvie.com . Follow @abbvie onLinkedIn, Facebook ,Instagram ,X andYouTube.

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: 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 escalation 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.
• 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.
• Remote position based in Madrid.

Additional Information

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.