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Clinical Operations Assistant

Full-Time Selangor, Malaysia
Health & Biotech
Health & Biotech
19 November 2024
Description
  • 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)
  • Experience in office management in an international environment would be advisable
       
Qualifications
  • 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

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