Senior Clinical Trial Manager - Remote

1w1 week ago

AbbVie

Madrid, ES · Full-time · €70,000 – €100,000

About this role

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address tomorrow's challenges. The company impacts lives in immunology, oncology, neuroscience, and Allergan Aesthetics portfolio. Join a team driving remarkable health solutions.

Execute one or more elements of clinical studies in compliance with ICH/GCP, global regulations, and AbbVie policies. Support the Study Project Manager in leading the cross-functional study team through meeting preparation and regular status updates. Ensure CTMS remains up to date for stakeholders.

Contribute to clinical study blueprint, protocol, and documents including informed consent forms, eCRFs, IRT, and CSR. Oversee vendor selection, scope development, management, and compliance. Generate training for study team, sites, and vendors.

Proactively identify, resolve, or escalate study-related issues. Participate in process improvement initiatives within a dynamic pharmaceutical environment. This remote role based in Madrid offers opportunities to advance clinical research expertise.

Requirements

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
At least four years of Pharma-related/clinical research related experience
Demonstrated high level of core and technical competencies
Possesses good communication skills
Competent in application of standard business procedures, SOPs, ICH, Global Regulations, Ethics and Compliance
Preferred exposure to study initiation through study completion

Responsibilities

Execute one or more elements of clinical studies in compliance with ICH/GCP, Global Regulations, and AbbVie policies
Support the Study Project Manager in leading the cross-functional study team including preparation of Clinical Study Team meetings and regular updates
Develop the clinical study blueprint/protocol and associated systems and documents such as Informed consent forms, eCRFs, IRT, CSR
Support vendor selection, scope development, management and oversight of external vendors in compliance with AbbVie processes
Generate study related training for the study team, study sites, and vendors
Proactively identify, resolve and/or escalate study related issues
Participate in process improvement initiatives