Parexel

About Parexel

Clinical Trial Operations As the Clinical Operations Assistant (COA) you will maintain the paper and electronic Central Files for Clinical Operation, ensuring efficiency, accuracy and quality. Depending on the location of the role may include the tracking, scanning, filing, entry and return of Case Report Forms to clients for assigned projects, upload and naming of documents to the electronic document management system, EDC User Management activities and activities associated with Impact Harmony, as appropriate. As the COA you will also support all site management team members on local billable administrative tasks and assist with QC of Central files. Key Accountabilities: Project Central Files & Clinical Trial Management Systems Maintenance and Updates 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 Support to all local site management team members (CMS) 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, vender and clients Collection of internal signatures for site documents (e.g. confidentiality agreement or clinical site agreements) within PAREXEL Overall Accountabilities 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 Qualifications Education: Relevant qualification or equivalent experience required - High school diploma – ideally degree in life science or other related background - preferred Skills: 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 skills Knowledge and Experience: Experience in office management in an international environment would be advisable Strong previous offcie based administration experience and skills is essential In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive base salary plus a great commission scheme as well as a benefits package including 25 days holiday per year, a strong contributory pension scheme, life assurance, long term disability insurance, private medical and private dental cover as well as other leading edge benefits that you would expect with a company of this type. Apply today to begin your PAREXEL journey!

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Company Info

Legal Form: co

Company Type: Private

Company Size: 5001 - 10000

Revenue: 300 - 1500 billion (TWD)

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Job Ads found: 38024

Job Ads per Month: 745.6

Hiring Locations: 1019

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