Ref #: 26184

Employment type: Permanent - Full-Time

Location: Seoul, South Korea

Posted: 19-Jan-2021

Description

Job Description :
Accountable for day to day activities of all aspects for the management of local company-sponsored studies, including study plans, timelines, resources, allocation and management of product (re-) supply, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
Accountable for the oversight of IST/ISS granted, including the support of the set-up and operational assessment of investigator-sponsor, tracking performance and payments according approved plan, managing product supply, if applicable, coordinating internal review of final report
Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
Develop and monitor study budget and timelines
Monitor work to ensure quality
Ensures that trial status is tracked and entered into the respective Clinical Trial Management System
Contribute to the planning and set-up of a study and provide planning parameters , Support early access programs on the country level

Description needs to cover the main tasks/ core activities of the job, geographical aspects, business expertise, problem solving, complexity of tasks and problems/ innovative solutions

Understanding of local / country requirements for clinical trials
Managing and steering CROs
Proactive issue monitoring and management

Financial Dimension:
Manages the budget for all local clinical studies and Global Phase IV studies assigned, as well as the IST/ISS grants.

Strategic Impact:
Coordinate within own country study management for all local clinical trials across all phases and therapy areas and for Global Phase IV trials, as well as the IST/ISS grants.
Support local organization in delivering local medical strategy across the portfolio within own country
Work with CRO in county to ensure local trials are delivered within desired quality, timelines, and costs

Requirements :
More than 8 years of experience in Clinical development/operations including more than a year of management experience
Thorough knowledge of ICH GCP and applicable local regulations
Analytical skills, quick perception and good judgment
Fluency in English (oral and written) plus local language
Medical or Life Sciences degree or equivalent qualification


If you would like to find out more about this please contact me on the details below:
Hailey Jung

Recruitment, South Korea
Hailey.Jung@docsglobal.com

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