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About the Role
As a Study Management Associate III, you will be part of a dynamic, centralized study management team responsible for executing global clinical trials. You will act as an independent, contributing member of a cross-functional and global partnership to plan, execute, and manage clinical trials under the guidance of the Study Project Manager and SMA Manager, ensuring quality, efficiency, timelines, and budget adherence.
Responsibilities
- Provide study-level oversight and leadership of global trials from inception through closure.
- Support the Study Project Manager in strategic leadership of the cross-functional team.
- Manage vendors, including RFP process, selection, scope of work, and risk management.
- Lead recruitment management, including strategy development and mitigation planning.
- Lead assigned meetings and provide regular updates on study status.
- Ensure inspection readiness and participate in related activities.
- Identify, mitigate, and manage risks, including issue escalation and trend analysis.
- Co-develop and manage study materials, including protocols, regulatory submissions, and reports.
- Manage CTMS and eTMF to ensure compliance and inspection readiness.
- Oversee EDC, IRT, and ePRO systems, including user acceptance testing and system management.
- Manage investigational product and associated study supplies.
- Provide training to identified stakeholders.
- Support global submission strategies.
- Support process improvement initiatives or serve as a subject matter expert/mentor.
Requirements
- Bachelor’s Degree or OUS 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.
- 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.
- Preferred: Exposure to study initiation through completion activities; global study exposure.
Skills
- Study management
- Clinical trial execution
- Cross-functional team leadership
- Vendor management
- Recruitment management
- Risk management
- Protocol development
- Regulatory submissions
- CTMS management
- eTMF management
- EDC
- IRT
- ePRO
- Stakeholder engagement
- Process improvement
Location
- Global
- Virtual
Work Type
- Full-time
Experience Level
- Associate III
- Grade 15 or 16
Education Level
- Bachelor's Degree
About the Company
- 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.
- AbbVie strives 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.
- AbbVie is an equal opportunity employer committed to integrity, innovation, improving lives, and community impact.
- AbbVie actively supports individuals with disabilities in achieving equal opportunities.
Equal Opportunity
- AbbVie is an equal opportunity employer committed to integrity, innovation, improving lives, and community impact.
- AbbVie actively supports individuals with disabilities in achieving equal opportunities.