Senior Clinical Trial Manager
BioSpace · Madrid, NY · 3 wk ago
Information TechnologyFull-time
Company Description
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.
Responsibilities
- Execute one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
- Support the Study Project Manager in leading the cross‑functional study team.
- Support the preparation of Clinical Study Team meetings (agenda/minutes).
- Provide regular updates to the cross‑functional team and stakeholders on study status; ensure the CTMS is up to date.
- Support the development of the clinical study blueprint/protocol and associated systems and documents (informed consent forms, eCRFs, IRT, CSR).
- Support vendor selection, scope development, management and oversight of external vendors in compliance with AbbVie’s processes and procedures and applicable regulations.
- Generate study‑related training for the study team, study sites, and vendors for assigned studies.
- Proactively identify and resolve and/or escalate study‑related issues.
- Participate in process improvement initiatives.
Qualifications
- Bachelor’s degree or OUS equivalent degree required, typically in nursing or scientific field; Registered Nurse licensure with an Associate’s Degree in Nursing with relevant experience is also acceptable.
- Minimum four years of pharma‑related/clinical research‑related experience and demonstrated high level of core and technical competencies.
- 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.
- At least 3 years in clinical trial management positions.
- Fluent in English (C1).
Additional Information
Remote position based in Madrid. Candidates must be located in Madrid even though the role is remote.