Senior Clinical Operations Assistant
Petaling Jaya, Malaysia ID de la oferta R0000027717 Categoría Clinical Trialssobre este trabajo
• Track, scan, code, and apply naming convention and send documents to the relevant study Work In Progress (WIP) area and Central File (CF) area of PMED as per the Central File Maintenance Plan.
• Filling and Archiving paper wet-ink documents in the Central Files office location as per the Central File Maintenance Plan (CFMP)
• Photocopy, print distribute and retrieval of documents, as needed
• Maintain basic quality check procedures to ensure accurate maintenance of documents
• Tracking/maintenance of the Clinical Trial Management System (CTMS) and study specific site trackers (Client additional request only)
• Monitoring of the status of systems and processes (e.g. annual reporting obligations, Site Compliance regarding Safety Information System (SIS) etc.) to ensure compliance
• Organization of translations of study document (e.g. contacting translation company, requesting approval via Oracle, following up with translation company to ensure timely delivery)
• Payment/invoice processing including internal follow up with payment specialists in Finance
• Courier shipment of study document to the sites, vendor and clients
• Collection of internal signatures for site documents (e.g. confidentiality agreement or clinical site agreements) within Parexel
• Assumes the ability to meet the requirements of a COA with a high degree of proficiency
• Effective time management in order to meet daily metrics or team objectives
• Able to work independently but seek guidance when necessary, escalating issues as required
Job Qualifications :
Skills:
• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
• Maintain a basic knowledge and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations and applicable Parexel procedures
• Good oral and written communication skills to internal and external customer
• Ability to prioritize multiple tasks and achieve project timeline
• High commitment to and performs consistently high-quality work
• Good written English and Japanese skills
Knowledge and Experience:
• Experience in office management in an international environment would be advisable
Education:
• Relevant qualification or equivalent experience required
• High school diploma – ideally degree in life science or other related background – preferred
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