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
Skills
Job Qualifications :
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
