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