Senior Clinical Trial Manager

ABBVIE; Madrid; Remote; EUR 90,000 - 120,000; Full time

Job summary

AbbVie is seeking a Study Management Associate III to join a centralized study management team responsible for executing global clinical trials. You will lead cross-functional activities from inception to closure with support from the Study Project Manager and SMA Manager, ensuring quality, timelines, and budget alignment in accordance with AbbVie standards.

The role requires rigorous experience in EDC/IRT/CTMS/eTMF, vendor management, recruitment planning, and global collaboration.

Qualifications

• Bachelor’s Degree or OUS equivalent required.
• At least 4 years pharma/clinical research experience.
• Proficient in SOP, ICH/GCP, and global regulations.
• Experience with EDC, IRT, CTMS, and eTMF.
• Strong analytical, organizational, and communication skills.
• Ability to work independently in a fast-paced global team.
• Experience leading cross-functional study teams.
• Vendor management and risk mitigation experience.
• Knowledge of study start through closeout activities.
• Remote role but based in Madrid.

Responsibilities

• Provide independent study leadership and cross-functional collaboration from inception to study closure.
• Support the Study Project Manager in strategic leadership and timely documentation.
• Manage vendors, including RFPs, scope of work, oversight, and risk management.
• Lead recruitment strategies and global subject enrollment planning.
• Ensure inspection readiness and participate in related activities.
• Oversee study materials, CTMS/eTMF, and data capture plans.
• Provide training to stakeholders and support global submission strategies.

Skills

Clinical trial leadership

Cross-functional collaboration

Vendor management

SOP/ICH/GCP knowledge

Data systems: EDC/IRT/CTMS/eTMF

Education

Bachelor’s Degree or OUS equivalent

Tools

EDC

IRT

CTMS

eTMF

Job 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.

Job Description

As a Study Management Associate III, you will be part of a dynamic, centralized study management team that is responsible for the execution of our global clinical trials and a key member of the study team.

The Study Management Associate III works as an independent, contributing member of a cross-functional and global partnership to plan, execute and manage one or more Phase 0-4 clinical trials under the guidance of the Study Project Manager and SMA Manager. The Study Management Associate III works to ensure that assigned studies are executed with quality and efficiency, in accordance with timelines and budget to support broader company strategic objectives. The Study Management Associate III is expected to work in accordance with all AbbVie Ways of Working.

Responsibilities

• The Study Management Associate III is expected to work independently as a clinical study leader and contributor with appropriate support from the Study Project Manager on the following activities in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures):
• Study-level oversight and leadership of one or more global trials in a cross-functional environment for activities from inception through closure, connecting functional work and strategic work across the global study, including but not limited to:
• o Supports the Study Project Manager in strategic leadership of the cross-functional team through stakeholder engagement and influence to drive deliverables and timelines, including strategy development, meeting facilitation, and timely documentation at the study level to drive for timely execution of clinical trial(s)
• o Vendor management, including Request for Proposal (RFP)/initiation, selection, Scope of Work development & review, deliverable oversight, and risk management for one or more external vendors, e.g., central lab, recruitment, imaging, internal and external committees
• o Recruitment management, including thoughtful review of intelligence data, leadership, cross-functional development, and execution of recruitment strategies and mitigation planning on a global scale from country feasibility through subject recruitment and retention
• o Leadership of assigned meetings (cross-functional (internal), vendor, and/or investigator) and provision of regular updates on study status, e.g., agenda development, minutes curation and filing. ; o Ensure inspection readiness and participate in related activities. Risk identification, mitigation, and management, including timely issue review, escalation, and management to support trend analysis and risk prevention.
• Co-development and management (review, revision, tracking and filing) of study materials, including but not limited to:
  • Protocols, regulatory submissions, patient reported outcome measures, study execution plan, informed consent, site budgets and agreements, clinical study report, training materials, newsletters, presentations for various stakeholders
  • CTMS and eTMF management to ensure compliance/inspection readiness, support trend analyses and support timelines
• o EDC, IRT, and ePRO, which includes review of design specifications, participation in user acceptance testing, and contribution to development and review of associated plans and key risk indicators, as well as system management activities like access support, query resolution, and oversight. Management of investigational product and other associated study supplies.
• Provide engaging training to identified stakeholders as needed, e.g., study team members, vendors. Support global submission strategies. Support process improvement initiatives or serve as a subject matter expert and/or mentor

Qualifications

List required and preferred qualifications (up to 10). Include education, skills and experience.

• Bachelor’s Degree or OUS equivalent required
• Must have at least 4 years of progressive Pharma-related/clinical research-related experience with a high level of core and technical competencies
• Competent in application of standard quality procedures (SOP, ICH/GCP, Global Regulations)
• Experienced user of systems such as EDC, IRT, CTMS, and eTMF
• Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives to actively develop strategies and drive smart decision making to support acceleration of study timelines and enable a well-run study.
• Excellent organizational and time management skills, strong attention to detail.
• Exceptional interpersonal skills with ability to communicate effectively in a clear and persuasive manner in a global setting; proficient in business/technical English-language (oral and written)
• Ability to work independently in a fast-paced global team environment
• Preferred: Exposure to study initiation through completion activities; global study exposure
• This is a remote position but must be 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.

US & Puerto Rico applicants seeking a reasonable accommodation,