About this role
Purpose
As a Study Management Associate II, 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 II works as a 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 a Study Project Manager and SMA Manager. The Study Management Associate II 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 II is expected to work in accordance with all AbbVie Ways of Working.
This is a global role and may be located virtually.
Responsibilities
The Study Management Associate II is expected to work as a clinical study 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 contribution to one or more global trials in a cross-functional environment for activities from inception through closure, including but not limited to: Supporting the Study Project Manager and cross-functional team through stakeholder engagement and influence to drive deliverables and timelines, including meeting facilitation and timely documentation at the study and regional levels 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 committeeso 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 retentiono 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
• 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 preventionCo-development and management (review, revision, tracking and filing) of study materials, including but not limited to:
o Protocols, regulatory submissions, study execution plan, informed consent, site budgets and agreements, clinical study report, training materials, newsletters, presentations for various stakeholders
o CTMS and eTMF management to ensure compliance/inspection readiness, support trend analyses and support timelineso 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 oversighto Management of investigational product and other associated study supplies
• Provide engaging training to identified stakeholders as needed, e.g., study team members, vendors
• Support process improvement initiatives or serve as a subject matter expert and/or mentor Qualifications
Bachelor’s Degree
Must have at least 2 years of pharma/device or clinical research related experience, with a moderate level of core and technical competencies
Competent in application of standard quality procedures (SOP, ICH/GCP, Global Regulations)Analytical and critical thinking skills to evaluate complex issues from multiple perspectives and contribute to strategy and smart decision making to support acceleration of study timelines and enable a well-run studyExcellent organizational and time management skills, strong attention to detail. Strong interpersonal skills with ability to communicate effectively in a clear and persuasive manner; proficient in business/technical English-language (oral and written) Proactive, collaborative mindsetAbility to work independently in a fast-paced global team environmentPreferred: Experience with 1 or more clinical trial systems (e.g., EDC, IRT, CTMS, eTMF); experience in 1 or more parts of a clinical trial 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 only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html