Clinical Data Validation Engineer Specialist - Softworld, Inc. - Cambridge, MA, US | Dice.com

Softworld, Inc.

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Clinical Data Validation Engineer Specialist

Cambridge, MA, US • Posted 20 hours ago • Updated 10 minutes ago

Contract W2

On-site

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Job Details

Skills

Clinical Data Validation Engineer Specialist

Summary

100% Remote

Objective / Purpose:

As a Clinical Data Validation Engineer, you will work on Clinical Trial Reporting activities delivering listings and visualizations to support clients Clinical Trials. In addition, you will operate in compliance with clients SOPs and processes.
Accountabilities:

Create data cleaning reporting solutions with appropriate oversight that support the quality and timely delivery of data cleaning, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans.

Create any documentation needed for reports throughout the lifespan of the study and/or asset for all deliverables.

Develop a library of reusable checks working closely with data engineers and config specialists.

Collaborate with cross functional teams in creating business rules and automated check library across TAU.

Complies with applicable SOPs and work practices.

Serves as a technical resource for creating data analytics to help with data validation and cleaning.

Supports knowledge development of others on reporting tools that support the accuracy and integrity of study data.

Provide programming expertise for data cleaning to efficiently ensure high quality data.

Enhances available reporting tools/macros/libraries or creates new ones to support the review of clinical trial data and trial status information for cross-functional use and provides input on data management reporting standards as required.

Creates and tests listings for data review.

Ensure operational excellence in collaboration with partners and colleagues for application of standards and develop data cleaning reports in support of the data review plan, in collaboration with the Clinical Data Management and medical reviewers.

Develop innovative, advanced new concepts that improve processes

Education & Competencies (Technical and Behavioral):

Bachelor's degree in computer science, statistics, biostatistics, mathematics, biology or other health related field or equivalent experience that provides the skills and knowledge necessary to perform the job.

Knowledge of drug development process.

Understanding regulatory requirements and relevant data standards; CDISC and SDTM knowledge and experience are preferable.

Minimum 2 years' experience in programming listings and/or visualizations with any of the following Veeva CDB, JReview and Elluminate.

Hands-on experience with report development in Elluminate required.

Experience with one of these languages: CQL, SQL, SAS, R, Python.

Knowledge of clinical database systems (Metadata Rave, Veeva, InForm).

Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.).

Strong working knowledge of clinical trial terminology.

Must be able to work in a fast-paced environment.

Ability to work independently, take initiative and complete tasks to deadlines.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: softwinc
Position Id: BBBH86765-587
Posted 20 hours ago

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