Clinical Data Standards Lead

Our client is looking for a Clinical Data Standards Lead. As a Clinical Data Standards Lead you will be working in one of the teams in the software engineering department focusing on patient facing mobile and web application for clinical studies. The Business Analyst in an agile environment, plays a critical role in bridging the gap between stakeholders and the team, together with the product owner and in helping Evinova deliver value

through iterative and customer-centric product development processes. It is expected that the Business Analyst is contributing to building and strengthening relations with our external and internal customers. The Business Analyst is also expected to contribute to defining and implementing improvements in the existing requirement processes and will be a member of the Core Business Analyst team.

Location: Spain (3 days a week if in Barcelona) or 100% remote

Work location: Fluent English

About the Team

Our client is building a team of experts called the Computational Data Squad, specializing in developing and implementing extensible solutions for automating and visualizing multi-source, complex data calculations as part of Evinova Platform’s clinical data pipeline. Their expertise lies in creating cutting-edge tools to manage intricate data scenarios, including composite endpoints such as CompEx. They are looking for an expert who deliver clinical data in CDISC-compliant data sets using Our clients measurement solutions, adhering to industry standards and regulatory requirements.

Overview of responsibilities

• Develops and enforces clinical data standards (preferably pulmonary therapeutic area) to enhance the efficiency, productivity, and quality of clinical data deliverables. These standards encompass industry standards like the CDISC SDTM (Study Data Tabulation Model), and ADaM (Analysis Data Model).

• Strong technical expertise and experience in Systems Development Life Cycle (SDLC) principles and product management.

Required skills & experience.

• 8-13 years of experience in Pharmaceutical industry

• Bachelor Degree

• 8 - 13 years of relevant experience in CDISC SDTM & ADaM.

• Advanced knowledge of clinical programming aspects of clinical research, data management,

standards compliance methodologies, metadata management and data analysis

• Advanced knowledge of programming, analysis, and reporting or data collection standards

• Advanced knowledge of CDISC standards for the creation and maintenance of end-to-end

standards from data collection to regulatory submission

• Advanced knowledge of all CDISC guidance documents and implementation guides

• Excellent written and oral communication skills, along with ability to present technical issues

• Advanced ability to work with management in the development and collection of metrics

• Advanced ability to collaborate with sponsors on standards implementations

• Demonstrated experience applying at least one data standard such as: CDASH, SDTM and

ADaM

• Experience in generating Questionnaire Response Datasets like the QRS dataset.

• Good knowledge of GCP / ICH guidelines

• Preferably, good knowledge of composite endpoint datasets consisting of multiple event types

like Ashma and COPD.

If you have a suitable candidate, please email me their CV, rate, how the candidate fits the role and meets the Required skills & experience.

Thanks!

Cornelia.renhult@nexergroup.com