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Senior Clinical Quality Assurance Engineer

Location Boston, United Kingdom
Posted 12-September-2021
Description
Product validation and end to end (source to consumption) data triaging and root cause analysis to ensure high quality data analytics product experience for the users
Implementation of CDISC standards including SDTM mapping, analysis datasets specifications, creation of Define.xml files, etc.
Build and enhance a functional, data and performance automation framework to ensure data quality and integrity.
Work with engineering leads, product managers, developers and peers to define, build and enhance overall test suit, processes and quality metrics.
Perform test script code reviews and manage revision controls as the test suites are for regulated clinical applications.
Design, develop, process and analyze data collections and processing from diverse sources, large scale structured and unstructured data.
Provide technical guidance, training and support to other team members.
Ensure compliance with industry quality standards, regulations, guidelines and procedures.
Manage multiple timelines and deliverables (for single or multiple clients) and managing client communications as assigned.
Meet automation test requirements and its maintenance to the highest standards.
Possess a can-do attitude and be passionate about building great automation solutions.

Requirements

Bachelors degree in a quantitative or engineering discipline or at least 8 years related comparable experience.
Minimum 5 years experience in biostatistics and/or regulatory submission as part of a Biotechnology, Pharmaceutical, or Life Sciences industries (Clinical Research Organization - CRO or Clinical Trial regulated environment preferred)Experience with EDC systems e.g., Medidata RAVE, Oracle Inform
GxP validation experience within the pharmaceutical industry
Strong experience in data conversion or implementation of validation rules
Experience within CDISC, SDTM mapping and/or creation of ADAM datasets, and Define.xml filesHL7 FHIR a plus
Experience and understanding of standard medical vocabularies e.g., LOINC, RxNorm, SNOMED CT
Strong interpersonal, communication, writing, presentation and facilitation skills
Detail-oriented with exceptional follow-through and superior organizational skills
Ability to communicate with technical teams (e.g., developers and engineers) effectively to drive effective issue resolution
Proven ability to work both independently and as part of a team; experience working as part of a distributed team
Proficient in working with relational databases e.g., MS SQL Server, Redshift and writing complex SQL queries
Hands-on experience in functional and data validation automation testing
Good understanding of the testing process, project test lifecycles, and techniques
Expertise in creating automated test scripts
Programming skills in JavaScript, VBScript, Java, etc.
Experience working with at least one Testing toolQTP, UFT, Selenium, TestNG, JMeter, Maven with POM based structure
Exposure to version control systems e.g., SVN, GIT, CVS, etc.
Experience on Jenkins
Strong problem-solving skills, data analysis, troubleshooting skills and use of defect/feature management systems, customer-oriented and results-driven

Desired Additional Experience

Experience with successful implementations of CDISC Standards and preparation of study data for regulatory submissions
Understanding of database design principles and best practices
Experience working in a cloud environment (AWS preferred)
Strong Software Development Lifecycle experience (Agile methodology experience is a plus)
Excellent understanding of relational database concepts, data modeling and design
Strong troubleshooting skills and use of defect/feature management systems
Proven ability to work independently and with technical team members (Startup environment experience is preferred
Experience in the Biotechnology, Pharmaceutical, or Life Sciences industries (Clinical Research Organization - CRO or Clinical Trial regulated environment preferred)
Exceptional attention to detail along with strong communication skills
Experience
Min 8 to 11 Years.

 
Awards & Accolades for MyTechLogy
Winner of
REDHERRING
Top 100 Asia
Finalist at SiTF Awards 2014 under the category Best Social & Community Product
Finalist at HR Vendor of the Year 2015 Awards under the category Best Learning Management System
Finalist at HR Vendor of the Year 2015 Awards under the category Best Talent Management Software
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