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- Project Lead (FSP)
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Project Lead (FSP)
Parexel International Corporation
Multiple Locations
You are required to contribute to the global drug development and regulatory PMS, ensuring that all clinical studies/projects assigned to you are well planned, conducted and reported in accordance with international guidelines such as ICH-GCP, company’s SOP/guidelines as well as relevant local regulations.
Some specifics about this role
Global Clinical Research Area:Collaborating closely with study team on full project management including clinical feasibility studies, selection of CROs/PIs/sites, contracts/budget negotiation, regulatory/EC submissions, site relationship management and site closure based on assigned projects’ needs.Participating in initiation meeting to ensure CROs provide appropriate training to site staff and implement appropriate procedurePerform regular quality oversights visits with Study Team or alone and prepare oversight visit report on a timely basisReview and manage the label of investigational productReview applications/documents for submissions to regulatory authorities and monitor clinical trial applications to obtain rapid approval for trial commencement
Administrative Area in Medical Division:Plan and manage budget for assigned projects in accordance with compliance program and internal SOPGenerate and revise internal local SOP in aligned with current activitiesProvide information and regular updates to CD team leader and other related departments on on-going/planned clinical studies/projects
Here are a few requirements specific to this role:Bachelor degree or above, major in pharmacy or health science related background.Excellent knowledge of ICH-GCP and local relevant regulations regarding safety reporting and promotional guideCRA II candidates with project management skills preferred.Good command of English (both written and spoken)Good presentation, communication and interpersonal skillsGood change and conflict management skills; able to identify issues and resolve problem efficientlyOpen to 3-day office-based work arrangement at Central SeoulThis is a 18-month contract role
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Job posted: 2022-09-24