Sr. Study Management Specialist

PURPOSE Manage and Lead complex and high-priority studies on all aspects of design, planning, startup, conduct, analysis, reporting and closeout of assigned NIS including regulatory PMOS, IIS and PAA. Responsible for managing planning, timelines, milestone, budget, study sites, vendors and deliverables while maintaining quality and compliance. CORE JOB RESPONSIBILITIES • Provide comprehensive input to study concept development especially from an operational, feasibility and study execution perspective. • Develop and manage study documentation throughout the study lifecycle, including protocols, protocol amendments, CRFs, informed consent forms and CSRs, and coordinate required reviews, approvals and regulatory submissions, as applicable. • Serve as the operational point of contact for MFDS for regulatory PMOS, including study-related communications and preparation of responses to supplementary requests regarding protocols, annual and final reports. • Lead the end-to-end operational management of assigned studies from concept through final reporting, including study planning, timelines, milestones, issue resolution, stakeholder communication and delivery of study objectives. • Lead study start-up activities and oversee vendor, CRO and study-site selection, set-up and performance to support timely and compliant study execution. • Manage study budgets, forecasting, reconciliation, FMV assessments and investigator payments in accordance with applicable requirements. • Manage PAA operations, including IP supply, importation and destruction; essential document development; applicable reviews, approvals and regulatory filings; and communication with MFDS, HQ, vendors and investigators. • Provide operational oversight of IIS activities, including concept and protocol review, committee approvals, FMV assessments, contracting, milestone tracking, payment management and issue resolution. • Act as a subject matter expert for study management processes including NIS, PMOS, IIS and PAA and Provide guidance and knowledge sharing to study team members. • Contribute to continuous process improvement initiatives to enhance study quality, compliance and operational efficiency. • Assure full compliance with GCP, Global & local SOPs, and Korean regulations • University degree or equivalent; preferably in a medical/science-related field or equivalent work experience in a scientific or health-related field • Minimum 7-year experience in clinical research in healthcare, pharmaceutical and/or CRO industry or minimum 5-years’ direct experience as a project manager . Demonstrated experience independently managing complex studies is preferred. • NIS experience is preferred • Fluent English communication skills (Reading, writing, speaking) • Good understanding of clinical trial processes, AbbVie internal processes and the regulatory environment as well as strong knowledge of clinical research practices, local regulations, and ICH guidelines • Familiarity with AbbVie policies & procedures and local SOPs • Strong computer/technology skills including MS Word, MS Excel and PowerPoint • Fluent English communication skills (Reading, writing, speaking) • Possess strong project management, time management and coordination skills with goodorganizational, leadership, negotiation and interpersonal skills • Strong analytical and problem-solving capabilities with sense of responsibility • Manage conflict, challenges, decision making and risk management as a project manager • Ability to manage time/prioritize, multitask, work independently, self-motivated and follow through with assigned tasks • Excellent written and verbal communication skills demonstrated by the ability to present clear messages from complex information/data to internal/external