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Business Analyst

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Fortune 500 Tech Company in Boston is looking for a new Business Analyst to join their team! This person will be responsible for managing a significant amount of data created during a recent clinical study.

Responsibilites:
The specific focus of the role is in auditing project records associated with the study closure and decommissioning of the clinical trial software. The role provides support to our team of Project Managers in the completion of Trial Lifecycle Records (TLR) and packaging of materials for distribution to the clients Trial Archive Package (TAP). These audits are performed on customer project records to ensure compliance with Standard Operating Procedures (SOP) and Work Instructions in preparation for customer delivery. The individual in this role will identify issues that need to be resolved and work with Business Analysts and Project Managers to finalize the records for delivery. The individual will also coordinate with document scanning vendors, Project Managers, Services Management, and Oracle's Production Operations team as well as obtain necessary signatures and ship packages to clients per established guidelines. Some additional duties included in this role include some general administrative tasks as needed in support of the Project Managers (e.g. printing, uploading documents, updating spreadsheets and project records) and some other QC responsibilities on an as needed basis

Specific tasks include:

Prepares Final Summary Reports for completed trials
Maintains TAP backlog tracking sheets for monitoring progress of clearing the backlog
Reviews TLRs for TAP for trials in the backlog
Prepares TAP (copies to external CD, packages and ships)
Requests Production paper documentation from storage for older trials
Coordinates scanning of paper documentation for inclusion in the electronic TAP
Follows up with PM’s to get signed TAP acceptance letters from customers within standard timeframes
Ships the final approved TAP discs to customers
Uploads missing documents to TLRs in VSS / SharePoint
Proactively assist Business Analysts and Project Managers in all aspects of Trial Archive and decommissioning including quality assurance and client satisfaction
Proactively track and communicate status updates to Business Analyst and the Services Management

Education and Experience:
We are looking for someone with 2-5 years experience in Quality Control of records and/or auditing experience
• Excellent teamwork and organization skills
• Strong interpersonal and communications skills
• Track record of managing multiple tasks effectively
• Demonstrated ability for rapid on-the-job learning, with excellent analytical and problem-solving skills
• Ability to learn and apply new technology
• Ability to work effectively in a fast-paced team or independent environment
• General proficiency with tools, systems and procedures required to accomplish the job (Microsoft Office)
• Able to accomplish straightforward tasks without assistance and require only occasional direction in aspects of day to day work for more complex tasks and or some technical issues
• Fluent in written and verbal English
• University Degree preferred, but may be substituted with comparable experience

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