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Document Specialist (R1038867) in Blue Bell, PA at IQVIA™

Date Posted: 1/10/2019

Job Snapshot

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Documentation Specialist

This is an exciting opportunity to work within a fast paced, busy environment for an innovative technology company. Headquartered in Blue Bell, PA, Wingspan Technology is a local software company serving global life science companies. Training is provided, and there is opportunity for advancement.

Job Description

•Process study documents in accordance with client and study requirements as per study-specific processes, Wingspan SOPs, and regulations, where applicable.

•Liaise with study teams and other Document Management staff in order to fulfill job responsibilities and activities.

•Maintain study files as per study and/or client requirements or in accordance with Wingspan and/or client SOPs/WPs and applicable regulations.

•Complete activities related to document receipt and processing which may include but is not limited to:  document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving.

•Provide information necessary to complete client and/or departmental status reports as requested by Wingspan and/or client management

•Inform manager of training issues, project activities, quality issues and timelines as directed.

•Participate in training related to fulfillment of responsibilities as required by Wingspan and/or the client.

•Liaise with Clients, as appropriate, on project issues when directed by Wingspan management.

•Assist with study migrations which will include:

•Creating document manifests and/or spreadsheets that will include document metadata for all documents included in the in-scope studies to be migrated

•Maintaining the data in these manifests and/or spreadsheets as the studies continue to progress

•Preparing the one or more Migration Manifest Files for each study migration

•Interact with Client CROs and other interested parties as needed to communicate data issues.

•Collaborating with Client business leads to ensure accuracy of data in the document manifests and/or spreadsheets

•Work with Wingspan Migration Project Team to ensure quality data migrations

•Handle special projects or duties as requested by Wingspan management.

Role Requirements        

•TMF (Trial Master File) and/or health sciences / drug development experience a plus

•Knowledge of Clinical Studies documents preferred

•Ability to successfully liaise with study project teams, staff, clients and management, as necessary.

•Good oral and written communication skills and interpersonal skills.

•Competent computer skills.

•Good attention to detail

•High school diploma is required.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled'

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™

Job ID: R1038867