Study Management Specialist

Company Description

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Purpose

Manage and lead a project 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, milestones, budget, study sites, vendors and deliverables while maintaining quality and compliance.

• Provide comprehensive input to study concept development, especially operational point of view
• Develop study protocol/protocol amendment and CRF and get approval from GUS‑RC or ARC and MFDS (if applicable) by managing multidisciplinary assessment
• Develop and provide official answers to MFDS by collecting and analyzing reference/data regarding supplementary comments from MFDS (protocol, annual report, re‑examination report) for regulatory PMOS
• Review and finalize CSR according to SOP and local regulation by coordinating and complying with all internal processes and approvals as well as MFDS
• MFDS point of contact: communicate/negoti‑ate with MFDS on protocol/protocol amendment, study implementation or issue for regulatory PMOS
• Study project management: accountable for all aspects of project management including study plans, operation, coordination, timelines, problem identification and resolution, communication with stakeholders, status reports and budget forecasting/planning, CRO management to reach the milestone and to ensure timely delivery of completed study reports
• Responsible to supervise daily operations and management of activities associated with assigned project(s) from concept to completion of final study report and ensure project goals are achieved
• Lead project start‑up activities such as vendor evaluation, bidding, selection, set‑up and training as well as study site evaluation and selection
• Manage and steer vendors including CROs to perform studies as planned
• Act as a liaison with internal and external stakeholders regarding study update, issue escalation, study specific information, etc.
• Develop study budget plan, forecasting, review, reconciliation. Manage project specific budget by monitoring and adjusting current study status as well as evaluating FMV and ensuring investigator payments occur in a timely/compliant manner
• Ensure effective project plans are in place and lead the project proactively with relevant stakeholders’ communication and to set priorities in accordance with applicable project plans
• PAA (Pre‑Approval Access Program): manage and conduct PAA with regards to IP supply, IP importation, IP destruction as well as communication with MFDS, HQ, vendor and investigators
• For PAA, if applicable, develop essential documents such as protocol, informed consent and get approval from GUS‑RC or ARC and MFDS as well as filing documents to MFDS
• For IIS (Investigator Initiated Studies), manage and oversight as an operational point, such as coordinate and support concept/protocol review and approval from all kinds of Review Committee (Affiliate, Global, Area), FMV assessment, managing agreements, documents, milestones (progress), payments, and issues
• 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 5‑year experience in clinical research in healthcare, pharmaceutical and/or CRO industry or minimum 3‑years’ direct experience as a project manager
• NIS experience is preferred
• Fluent English communication skills (Reading, writing, speaking)
• Good understanding of clinical trial processes, Abb Vie internal processes and the regulatory…