Associate, Study Management II

AbbVie•Chicago, IL

3d•$84,500 - $162,000

About The Position

The Study Management Associate II is a contributing member of a centralized, cross-functional global study management team responsible for planning, executing, and managing one or more Phase 0–4 clinical trials under the guidance of a Study Project Manager and SMA Manager. The role supports quality and efficient study execution in accordance with timelines, budgets, ICH/GCP, global regulations, and AbbVie policies and procedures. This is a global role and may be located virtually. The position contributes to study oversight from inception through closure, including stakeholder coordination, vendor and recruitment management, meeting leadership, risk management, inspection readiness, study-material development and management, clinical trial system oversight, and management of investigational products and study supplies. The Associate also provides training and may support process improvement initiatives or serve as a subject matter expert or mentor.

Requirements

Bachelor’s degree or OUS equivalent.
At least 2 years of pharma/device or clinical research-related experience, with a moderate level of core and technical competencies.
Competence in applying standard quality procedures, including SOPs, ICH/GCP, and global regulations.
Analytical and critical-thinking skills to evaluate complex issues from multiple perspectives and contribute to study strategy and decision-making.
Strong organizational and time-management skills and attention to detail.
Strong interpersonal skills and the ability to communicate clearly and persuasively; proficiency in business/technical English, orally and in writing.
Proactive and collaborative mindset.
Ability to work independently in a fast-paced global team environment.

Nice To Haves

Experience with one or more clinical trial systems, such as EDC, IRT, CTMS, or eTMF.
Experience in one or more parts of a clinical trial.

Responsibilities

Contribute to oversight and execution of one or more global clinical trials from inception through closure in a cross-functional environment.
Support the Study Project Manager and cross-functional team through stakeholder engagement, meeting facilitation, documentation, and coordination of study and regional deliverables and timelines.
Manage external vendor activities, including requests for proposals, initiation, selection, scope-of-work development and review, deliverable oversight, and risk management.
Support global recruitment planning and execution, including review of intelligence data, strategy development, mitigation planning, country feasibility, subject recruitment, and retention.
Lead assigned cross-functional, vendor, and/or investigator meetings; develop agendas, curate and file minutes, and provide regular study-status updates.
Ensure inspection readiness and participate in related activities.
Identify, mitigate, and manage risks; review and escalate issues in a timely manner and support trend analysis and risk prevention.
Co-develop and manage study materials, including protocols, regulatory submissions, study execution plans, informed consent documents, site budgets and agreements, clinical study reports, training materials, newsletters, and stakeholder presentations.
Manage CTMS and eTMF activities to support compliance, inspection readiness, trend analyses, and timelines.
Support EDC, IRT, and ePRO activities, including review of design specifications, user acceptance testing, development and review of plans and key risk indicators, access support, query resolution, and system oversight.
Manage investigational product and other associated study supplies.
Provide training to identified stakeholders, such as study team members and vendors.
Support process improvement initiatives or serve as a subject matter expert and/or mentor.