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Manage interdisciplinary clinical research projects and lead the clinical team to ensure the on-time according to ICH GCP and any applicable regulations and guidelines.
Conduct pre-study, initiation, routine monitoring, audit and close-out visits in accordance with International standard guidelines, ICH-GCP, KGCP, SOPs and/or relevant guidelines.
Review and develop study related documents including protocols, CRF, IB and ICF.
Review and approve the investigator site selection.
Develop, review, and negotiate investigator budgets and contracts.
Review and approve regulatory and administrative documents from investigators sites and CROs
Plan, coordinate, and present at study related meetings with investigators, Vendors and internal management groups etc.
Review Serious Adverse Event (SAE) reports.
Prepare and review project status reports for project personnel
Review and approve trip reports.
Participate in periodic in-house project status review, including project financial review, with senior management.
Manage third party vendors including CRO.
Review and approve invoices from CRO, Vendors and study sites.
Perform in-house CRA activities (such as verify CRF, queries, ISF/TMF maintenance) as defined in the monitoring plan. (if necessary)
Review proposal and Select Vendors including CRO
Review Tables and Listings generated from study data.
Manage and train junior staff including CRA or team member.
Minimum Requirements:
1. Bachelor¡¯s degree in pharmacy, life sciences, or nursing credential.
2. Six years of experience in clinical research, with two years of project management experience as a PM or study lead (LEAD CRA). Must have 3 years of clinical monitoring experience in lieu of project management experience. (Preferred sponsor PM experience)
3. Good planning, organization, and problem-solving skills.
4. Able to manage the time and work independently.
5. Excellent written and verbal communication skills in English and Korean.
6. Very good working knowledge of relevant software such as MS-office (Excel, Word, and PowerPoint).
This job description does not list all the duties of the job. Employees may be asked by supervisors or management to perform other duties.
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1. À̷¼ Á¦Ãâó: À̸ÞÀÏ npc@nowpharm.co.kr
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1) ¿î¿µÃÑ°ý ÃÖ³«¿ì´ëÇ¥ 010-2369-4316
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