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Clinical Data Configuration Manager

Role overview

Summary

The Clinical Data Configuration Manager supports clinical study execution by configuring data extractions, transformations, and transfers across multiple sources. This role collaborates with stakeholders to ensure high-quality data delivery and contributes to the development of transfer standards and best practices within Veramed's R&D Testing, Innovation, and Data Enablement organization.

Qualifications

  • Bachelor's degree in CS, Statistics/Biostatistics, math, biology/health related plus minimum 5 years relevant experience.
  • Experience with EDC build/data management or EDC extraction/configuration; strong understanding of clinical data flow.
  • Familiarity with data cleaning tools such as Veeva CDB, J Review, Elluminate; strong clinical trial terminology and data transfer specification knowledge.
  • Preferred: Data/Integration experience with XMLs, APIs, MDR (preferred); ETL/ELT experience.
  • Preferred: Programming experience with SQL, SAS, R or Python (preferred); R Shiny/Python app development.

Responsibilities

  • Configure study-level clinical data extraction, transformation, and transfer outputs across multiple data sources per Data Transfer Agreement/specifications.
  • Partner closely with internal/external stakeholders to deliver required data formats/frequencies with high quality and on time.
  • Support implementation of sponsor-defined data transfer standards and specifications.
  • Perform/coordinate quality review of configuration and deliverables, including oversight/review of vendor-performed work as needed.

Key facts

Hard skills

Other skills

  • Microsoft Office
  • Problem Solving
  • Detail Oriented
  • Time Management
  • Collaboration

About the company

Veramed logo

Veramed

  • Clinical Research (CRO)
  • 51–200
By following Veramed you can find out the latest information and updates on the company, conferences we are visiting and how Veramed are innovating. Veramed is a customer-driven Clinical Research Organisation (CRO) that provides high quality biostatistics and programming services for the pharmaceutical and biotech industry. Founded in 2012, Veramed acts as an extension to its clients’ teams, ensuring close collaboration and efficient, quality-driven outcomes that go above and beyond CRO industry standards. Headquartered in Twickenham, England, with UK offices in Manchester, Swansea, as well as Europe and the US, Veramed is B Corp Certified ® with people, patients and the environment at its heart. Our growing team of expert statisticians and statistical programmers is focused on providing high quality analysis and consultancy of Phase I-IV clinical trials across a variety of therapeutic areas for the pharmaceutical industry. Our vision To be regarded as the biometrics CRO of choice - a company that delivers an industry-leading customer experience, with a reputation for quality, innovative solutions and service excellence. Our mission- To achieve and maintain an unparalleled reputation for quality and service by always being easy to work with, investing in ourselves to continually improve, and being proud of what we do. You can read about what it's like to work at Veramed here - https://www.glassdoor.co.uk/Overview/Working-at-Veramed-EI_IE1495716.11,18.htm

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Job description

Veramed is a Clinical Research Organization (CRO) that provides expert data management, biostatistics and programming services to the pharmaceutical and biotech industry. With precision, consistency and an unwavering commitment to quality, Veramed is dedicated to setting the highest standards for biometrics in clinical trials.

Founded in 2012, Veramed has always been guided by quality, integrity and humanity. This means a culture that genuinely cares for its employees, and employees that genuinely care about the work they do, enabling unparalleled collaboration for industry-leading delivery. 

Veramed’s growing team of expert data managers, statisticians and statistical programmers supports analysis and consultancy of Phase I-IV clinical trials across a variety of therapeutic areas. Whether it’s long-term partnerships or rapid-fire project work, Veramed works as an extension of clients’ teams, driving efficient, dependable outcomes. 

A truly global CRO, Veramed is headquartered in Twickenham, England, with offices across the UK, Europe, US and India. Veramed is proud to be B Corp Certified ®, committed to integrity and impact in everything we do. 

Our vision 

We exist to set the new standard for biometrics. By making the right decisions – for our employees, for sponsors, and for patients – we’re redefining what biometrics can deliver in clinical trials.

Purpose of the role

The Clinical Data Configuration Manager sits within R&D’s Testing, Innovation, and Data Enablement organisation and supports clinical study execution by configuring study-level clinical data extractions, transformations, visualisations, and transfers across multiple data sources in alignment with Data Transfer Agreements and technical specifications. This role partners with internal and external stakeholders (including data engineers) to deliver accurate, high quality data in required formats and frequencies , contributes to the development and training of transfer standards/ SOPs and best practices, and provides quality oversight and team capability support (including mentoring/training others and vendor /FSP oversight as needed) to ensure consistent, on time delivery.

Accountabilities:

  • Configure study-level clinical data extraction, transformation, and transfer outputs across multiple data sources per Data Transfer Agreement/specifications.
  • Partner closely with internal/external stakeholders (including Data Engineers) to deliver required data formats/frequencies with high quality and on time.
  • Support implementation of sponsor-defined data transfer standards and specifications.
  • Provide input to documentation and training materials as requested.
  • Perform/coordinate quality review of configuration and deliverables, including oversight/review of vendor-performed work as needed.
  • Support team capability by managing and training other team members; complete other assigned duties within timelines.

Education:

  • Bachelor's degree  (e g., CS, Statistics,/Biostatistics, math, biology/heath related) plus minimum 5 years relevant experience (or equivalent experience).
  • Experience with EDC build/data management or EDC extraction/configuration; strong understanding of clinical data flow (CDMS, vendor devices, CDR). 
  • Familiarity with data cleaning tools (e.g. Veeva CDB, J Review, Elluminate); Strong clinical trial terminology and data transfer specification knowledge; understanding of SDTM.
  • Data/Integration: XMLs, APIs, MDR (preferred); ETL/ELT experience
  • Programming (preferred): One or more SQL, SAS, R or Python; R Shiny/Python app development.
  • Tools/ways of working: Microsoft Office
  • Independent and collaborative problem-solving; ability to prioritize and work in a fast-paced environment.
  • Strong project management skills including: Initiative, deadline management, strong attention to detail, organization, time management; quick learner comfortable with new tech/systems.

Veramed is a B Corp accredited company which means that we use the power of business to build a more inclusive and sustainable economy meeting the highest verified standards of social and environmental performance, transparency, and accountability.

As an organisation that has people at the heart of it, Veramed is committed to creating a diverse environment and is proud to be an equal opportunities employer. We foster a working culture where employees have integrity, honesty and respect for one another without regard to race, national origin, religion, gender identity or expression, sexual orientation or disability. All qualified applicants will receive equal consideration for employment.

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