Senior Clinical Trial Manager

🔥 17 hours ago

🇪🇸 Spain – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Plan, execute, and manage one or more Phase 0–4 global clinical trials • Provide study-level oversight and leadership in a cross-functional environment from inception through closure • Support strategic leadership of cross-functional teams through stakeholder engagement and influence • Develop strategies, facilitate meetings, and maintain timely study-level documentation • Manage external vendors, including RFPs, selection, scope of work, deliverables, and risk management • Lead global recruitment strategy, feasibility, subject recruitment, retention, and mitigation planning • Lead cross-functional, vendor, and investigator meetings; prepare agendas and curate and file minutes • Ensure inspection readiness and participate in related activities • Identify, mitigate, and manage risks, including issue review, escalation, and trend analysis • Co-develop and manage protocols, regulatory submissions, patient-reported outcome measures, study execution plans, informed consent, site budgets and agreements, clinical study reports, training materials, newsletters, and presentations • Manage CTMS and eTMF for compliance, inspection readiness, trend analysis, and timelines • Support EDC, IRT, and ePRO design review, user acceptance testing, plan development, risk indicators, access, query resolution, and system oversight • Manage investigational product and associated study supplies • Provide stakeholder training • Support global submission strategies • Support process improvement initiatives or serve as a subject matter expert and/or mentor

🎯 Requirements

• Bachelor’s Degree or OUS equivalent required • At least 4 years of progressive Pharma-related/clinical research-related experience • High level of core and technical competencies • Competent in standard quality procedures, including SOP, ICH/GCP, and Global Regulations • Experienced user of EDC, IRT, CTMS, and eTMF • Strong analytical and critical thinking skills • Excellent organizational and time management skills • Strong attention to detail • Exceptional interpersonal and communication skills in a global setting • Proficient in business/technical English-language, oral and written • Proactive, collaborative mindset • Ability to work independently in a fast-paced global team environment • Preferred: exposure to study initiation through completion activities and global study exposure

🏖️ Benefits

• Equal opportunity employer • Committed to operating with integrity, driving innovation, transforming lives and serving the community

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