Job Summary

• Serve as the primary contact for Post Database Lock Final Archive Product for multiple studies simultaneously.
• Identify, locate, collect, verify, and organize company documentation
• Perform initial documents audit upon formal archive request
• Provide templates of standard Archive documents to the Study Team and create multiple study specific documents for inclusion in the archive
• Set up the complex directory structure required by both the Site and Sponsor portions of the archive and place the acquired documents in the appropriate folders in both Site and Sponsor portions of the archive
• Identify, locate, collect, verify, and organize documentation
• Assist the Lead Archive Manager with Data Generation such as acquisition of the Study Design, setup of the required environment on one of the data generation servers, running the missing DCR check report, and generating the appropriate emails based on the results
• Provide Data Generation Certification
• Weekly emails to Project Management team to request outstanding documentation
• Perform Post Data Generation processing after Data Generation is handed off by the Lead Archive Manager
• After quality check, zip and upload the completed archive to the shipping vendor and communicate with the vendor to inform of priority and any other archive specific details that the vendor will need
• Follow up with the shipping vendor to acquire tracking, forwarding the tracking to the study team, and initiating the “Notice of Archive Delivery” email
• Assist the Clinical Data Designer Associate by performing quality checks on EPX archives prior to upload.
• Manage and update Archive Metrics and SmartSheet milestones on a daily, weekly, and monthly basis

Job Requirements

• Advanced level of English 
• Ability to multitask, prioritize, and manage time efficiently
• Minimum of 2-5 years Data Management or transferable skillset related experience
• BS/BA degree preferred
• Exceptional organizational skills
• Ability to drive the archive process from start to finish
• Proficient in Microsoft Office applications and Adobe Acrobat
• Ability to manage multiple priorities and to switch focus seamlessly
• Excellent communication skills and the ability to work well with others
• A commitment to meet deadlines with a keen focus on details

How to Apply

interested and qualified applicant should apply through the email below

HR@metropolitanaddis.com

Please use "ARCHIVE SPECIALIST" as mail subject line