Job Overview
Supports the DTL in providing end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Conducts and assists in the oversight of data management activities including database set-up, production of edit checks and SAS listings, data transfer, data tracking, data reconciliation, data cleaning, database lock and archiving activities as well as data coding. Prepares and reviews DM documentation including status reports to Client. Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.
Essential Functions
Client Management:
Produces Client status reports (metrics, study trackers etc.
Reviews and applies client comments/findings from data review, DMP documents and issue logs.
May attend client calls, providing support for preparation of slides, metrics or other needs.
Service Management:
With minimal supervision, oversees study data tracking, cleaning, reconciliation and coding process; liaises with DTL, Data Operations Coordinator (DOC), Medical Data Reviewer, Coder and/or Data Operations team members on a regular basis to ensure data are tracked, cleaned, reconciled and coded in line with agreed project timelines and quality requirements. Performs data cleaning activities as required.
With close supervision, assists the DTL as required in the oversight and conduct of other data management activities (e.g. database set-up, data transfer etc.)
With close supervision, creates and maintains DMP documents Reviews all other documents in the DMP.
With close supervision, maintains the DM folders in the eTMF.
Provides administrative assistance to the DTL as required (e.g. taking meeting minutes, organising meetings etc.)
Continuously looks for opportunities to improve efficiency of tasks and quality of deliverables · Identifies compliance issues and works with functional manager(s) to ensure timely follow-up and resolution
With close supervision, maintains internal tracking databases and systems as required. · With close supervision, may serve as back-up DTL in the absence of the DTL
Financial Management/Business Development Support:
Assists the DTL in monthly financial tracking/forecasting tasks, the identification of out of scope tasks and tracking of change orders to completion
Other: With close supervision, may:
Provide input on DM process improvements or project solutions to CDM team/CDM department
Provide input on the development and implementation of a new technology or tool
Participate in a focus team or global or local best practice team
Perform other duties as directed by functional manager(s)
Qualifications
Bachelor's Degree Clinical, biological or mathematical sciences, or related field Req
Equivalent combination of education, training and experience in lieu of degree.
Three years direct Data Management experience which can include experience from Academia or other industries, ideally in the area of Data Cleaning.
Advanced proficiency in English
Experience with Electronic Data Capture (EDC) platforms and/or database platforms.
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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
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