Allergan Aesthetics, an AbbVie company, is looking for an Associate, Study Management III to join our centralized study management team. In this role, you will be a key contributor in planning, executing, and managing one or more Phase 0-4 global clinical trials, ensuring they are delivered with quality and efficiency under guidance.
What You'll Do
- Provide study-level oversight and leadership of one or more global trials in a cross-functional environment from inception through closure.
- Support the Study Project Manager in strategic leadership of the cross-functional team through stakeholder engagement and influence to drive deliverables and timelines.
- Manage vendors, including RFP/initiation, selection, Scope of Work development & review, deliverable oversight, and risk management.
- Manage recruitment, including review of intelligence data, development, and execution of recruitment strategies and mitigation planning on a global scale.
- Lead assigned meetings (cross-functional, vendor, and/or investigator) and provide regular updates on study status.
- Ensure inspection readiness and participate in related activities.
- Identify, mitigate, and manage risks, including timely issue review, escalation, and management.
- Co-develop and manage study materials (protocols, regulatory submissions, patient reported outcome measures, study execution plan, informed consent, site budgets and agreements, clinical study report, training materials, newsletters, presentations).
- Manage CTMS and eTMF to ensure compliance/inspection readiness, support trend analyses and support timelines.
- Manage EDC, IRT, and ePRO, including review of design specifications, participation in user acceptance testing, and contribution to development and review of associated plans and key risk indicators.
- Manage investigational product and other associated study supplies.
- Provide engaging training to identified stakeholders as needed.
- Support global submission strategies.
- Support process improvement initiatives or serve as a subject matter expert and/or mentor.
What We're Looking For
- Bachelor’s Degree.
- 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.
- 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).
- Proactive, collaborative mindset.
- Ability to work independently in a fast-paced global team environment.
Nice to Have
- Exposure to study initiation through completion activities; global study exposure.
Technical Stack
- EDC
- IRT
- CTMS
- eTMF
Team & Environment
Part of a centralized study management team and a key member of the study team. Works under the guidance of the Study Project Manager and SMA Manager.
Work Mode
This is a global position.
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.
