Study Management Specialist - FSP

Study Management Specialist - FSP

Responsibilities:

• 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 answer 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 comply with all internal processes and approvals as well as MFDS - MFDS point of contact: Communicate/Negotiate 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 stake holders, 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
• Acts 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 document 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 kind 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

Qualifications and job requirements:

• 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 year direct experience as a project manager
• 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 of 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 good organizational, 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 stakeholders