Associate, Study Management III

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.

About the role

As a Study Management Associate III, you will be part of a dynamic, centralized study management team responsible for the execution of global clinical trials and a key member of the study team. This global role 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, including:
  • 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.
  • Vendor management, including Request for Proposal (RFP)/initiation, selection, Scope of Work development & review, deliverable oversight, and risk management for external vendors (e.g., central lab, recruitment, imaging, internal and external committees).
  • Recruitment management, including 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.
  • Leadership of assigned meetings (cross-functional, vendor, and/or investigator) and provision of regular updates on study status, including agenda development, minutes curation, and filing.
  • 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:
  • Protocols, regulatory submissions, patient-reported outcome measures, study execution plan, informed consent, site budgets and agreements, clinical study report, training materials, newsletters, and presentations for various stakeholders.
• CTMS and eTMF management to ensure compliance/inspection readiness, support trend analyses, and support timelines.
• EDC, IRT, and ePRO management, including review of design specifications, participation in user acceptance testing, 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

• Bachelor’s Degree or equivalent required.
• 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 and drive smart decision-making to support acceleration of study timelines.
• Excellent organizational and time management skills, with 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 (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; global study exposure.

Benefits

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

Pay

The compensation range is based on the job grade for this position at the time of posting. Individual compensation paid within this range will depend on many factors, including geographic location, and may be modified in the future. This role may also be eligible for bonuses or commissions.