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- 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
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