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

Date Posted: 9/10/2018

Job Snapshot

Job Description

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.



Job ID: R1038867