[Hiring] Study Management Associate III @AbbVie

Role 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. This is a global role and may be located virtually.

Responsibilities

• Study-level oversight and leadership of one or more global trials in a cross-functional environment for activities from inception through closure.
• Supports the Study Project Manager in strategic leadership of the cross-functional team through stakeholder engagement and influence to drive deliverables and timelines.
• 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.
• Recruitment management, including thoughtful review of intelligence data, leadership, cross-functional development, and execution of recruitment strategies and mitigation planning on a global scale.
• Leadership of assigned meetings (cross-functional (internal), vendor, and/or investigator) and provision of regular updates on study status.
• 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 of study materials, including but not limited to protocols, regulatory submissions, and informed consent.
• CTMS and eTMF management to ensure compliance/inspection readiness.
• EDC, IRT, and ePRO management, including review of design specifications and participation in user acceptance testing.
• Management of investigational product and other associated study supplies.
• Provide engaging training to identified stakeholders as needed.
• Support global submission strategies and process improvement initiatives.

Qualifications

• Bachelor’s Degree or OUS equivalent required.
• At least 4 years of progressive Pharma-related/clinical research-related experience.
• 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.
• Excellent organizational and time management skills, strong attention to detail.
• Exceptional interpersonal skills with ability to communicate effectively in a global setting.
• Proactive, collaborative mindset.
• Ability to work independently in a fast-paced global team environment.
• Preferred: Exposure to study initiation through completion activities; global study exposure.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical/dental/vision insurance.
• 401(k) to eligible employees.
• Participation in short-term incentive programs.