Ref #: 32076

Employment type: Permanent - Full-Time

Location: Seoul, South Korea

Posted: 15-Sep-2021

Description

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Role: PMS Clinical Research Associate (CRA)

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
• 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 management
• 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

Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

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