AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Study Management Specialist
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, milestone, 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 answer to MFDS by collecting and analyzing reference/data regarding supplementary comments from MFDS (protocol, annual report, reexamination 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 o 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, setup and training as well as study site evaluation and selection
- Manage and steer vendors including CROs to perform studies as planned o Acts as a liaison with internal and external stakeholders regarding study update, issue escalation, study specific information, etc. o 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
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
Job Type: Experienced
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