( Japanese team ) Clinical Operations Assistant
Petaling Jaya, Malaysia Job ID R0000027927 Category Clinical TrialsAbout this Role
Project Trails Master File
•Track, scan, code, input meta data, and/or apply naming convention and send/file documents to the relevant study Trial Master File (TMF) as per the Trial Master File Plan.
• Filling and Archiving paper wet-ink documents in the Central Files office location as per the Trial Master File plan
• Photocopy, print, distribute and retrieval of documents, as needed
• Support on creating and review of Note to Files (NTF)
• Maintain basic quality check procedures to ensure accurate maintenance of documents
• Review/update TMF country and site issues in 30 days
• Review/update EDL (Essential Documents List)
• Review/update TMF milestones
• Clear QC stops (if applicable)
• Missing Letter Support (e.g. FUP letter, confirmation letter, cover e-mails, etc...)
• Follow up with sites regarding pending documents
• Transfer of documents to sponsor TMF systems (if applicable)
Vendor Management
Track and manage vendor communication related to site staff access to systems (e.g. EDC, IVRS) during activation
• Follow up with sites
• Study specific completion training
Payment Support
•Review if Site payments funds are completed as per site contracts and follow up with responsible team accordingly
Support to all local site management team members (CRA, iCRA, COL, SSUL)
Skills:
• Proficient in English and Japanese (JLPT N1 level) languages
• 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
• Flexibility to perform multiple tasks and ability to prioritize these to achieve project timeline
• High commitment to and performs consistently high-quality work
• Effective problem-solving skills
• Mentor and train less experienced staff as appropriate
• Active participant as a process and/or platform Subject Matter Expert (SME) with minimal LM oversight
• Demonstrate attitude, teamwork, proactiveness and confidence
Knowledge and Experience:
• Experience in office management in an international environment would be advisable
Education:
• Relevant qualification or equivalent experience required
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