Associate Study Management III

AbbVie

22h

About The Position

The Study Management Associate III works independently as a clinical study leader and contributor, with appropriate support from the Study Project Manager. The role provides study-level oversight and leadership for one or more global clinical trials in a cross-functional environment, from inception through closure, while complying with ICH/GCP, global regulations, and AbbVie policies and procedures. The position supports strategic leadership of cross-functional teams; oversees vendors, recruitment strategies, meetings, study risks, and inspection readiness; and co-develops and manages study materials and clinical systems. It also manages investigational product and study supplies, provides stakeholder training, supports global submission strategies, and contributes to process improvement or serves as a subject matter expert or mentor.

Requirements

Bachelor’s degree or OUS equivalent.
At least 4 years of progressive pharmaceutical-related or clinical research-related experience, with a high level of core and technical competencies.
Competency in applying standard quality procedures, including SOPs, ICH/GCP, and global regulations.
Experience using systems such as EDC, IRT, CTMS, and eTMF.
Strong analytical and critical-thinking skills, including the ability to evaluate complex issues from multiple perspectives, develop strategies, and support decision-making to accelerate study timelines and enable well-run studies.
Excellent organizational and time-management skills and strong attention to detail.
Exceptional interpersonal skills and the ability to communicate clearly and persuasively in a global setting.
Proficiency in business and technical English, both oral and written.
Proactive, collaborative mindset.
Ability to work independently in a fast-paced global team environment.

Nice To Haves

Exposure to study activities from initiation through completion.
Global study exposure.

Responsibilities

Support the Study Project Manager in leading cross-functional teams through stakeholder engagement, strategy development, meeting facilitation, and timely documentation to drive study deliverables and timelines.
Manage external vendors, including requests for proposals, initiation, selection, scope-of-work development and review, deliverable oversight, and risk management.
Lead global recruitment activities, including reviewing intelligence data, developing and executing recruitment strategies, and planning mitigations from country feasibility through subject recruitment and retention.
Lead assigned internal cross-functional, vendor, and 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 promptly to support trend analysis and risk prevention.
Co-develop and manage study materials, including protocols, regulatory submissions, patient-reported outcome measures, study execution plans, informed consent documents, site budgets and agreements, clinical study reports, training materials, newsletters, and stakeholder presentations.
Manage CTMS and eTMF to support compliance, inspection readiness, trend analyses, and timelines.
Support EDC, IRT, and ePRO systems by reviewing design specifications, participating in user acceptance testing, contributing to plans and key risk indicators, and performing system management activities such as access support, query resolution, and oversight.
Manage investigational product and other study supplies.
Provide training to identified stakeholders, such as study team members and vendors.
Support global submission strategies.
Support process improvement initiatives or serve as a subject matter expert and/or mentor.