Lead the development, implementation, and maintenance of clinical data standards for clinical trials, ensuring alignment with industry standards and regulatory requirements (e.g., CDISC, FDA, EMEA).
Develop CDISC-compliant datasets and metadata, focusing on standards such as SDTM (Study Data Tabulation Model), ADaM (Analysis Data Model), and Define-XML.
Collaborate with internal and external stakeholders to ensure clinical data standards are implemented consistently and accurately across projects.
CDISC Expertise & Implementation:
Act as the subject matter expert (SME) on CDISC standards, guiding the team on proper implementation and adherence to these standards across clinical studies.
Maintain up-to-date knowledge of evolving CDISC standards, industry trends, and regulatory requirements (FDA, EMA, ICH) to ensure compliance and best practices.
Provide guidance on CDISC data collection, data mapping, and metadata management.
Programming & Data Analysis:
Develop and maintain scripts in R, Python, and SQL to automate data extraction, transformation, and validation tasks.
Use programming skills to conduct data analyses, generate reports, and ensure clinical data is properly structured and compliant with the necessary standards.
Perform data quality assessments and validation checks to ensure consistency and accuracy of clinical trial data.
Collaboration & Stakeholder Engagement:
Work closely with cross-functional teams, including clinical operations, biostatistics, IT, and regulatory affairs, to ensure that clinical data is managed effectively throughout the study lifecycle.
Provide expertise and support to clinical teams on data standards implementation, including training and troubleshooting.
Influence key stakeholders, including external vendors, to adopt and adhere to the required clinical data standards.
Documentation & Compliance:
Maintain clear and accurate documentation of all data standards, protocols, procedures, and data models.
Ensure all clinical data is compliant with industry regulations and meets the requirements of health authorities, including submission standards (e.g., for FDA and EMA filings).
Participate in audit preparation, ensuring the availability of the necessary documentation for regulatory inspections.
Continuous Improvement:
Identify and implement process improvements related to clinical data management, standards development, and automation.
Contribute to the development of best practices and the standardization of processes for clinical data handling and reporting.
Key job details
About Virtusa
Teamwork, quality of life, professional and personal development: values that Virtusa is proud to embody. When you join us, you join a team of 36,000 people globally that cares about your growth — one that seeks to provide you with exciting projects, opportunities and work with state of the art technologies throughout your career with us.
Great minds, great potential: it all comes together at Virtusa. We value collaboration and the team environment of our company, and seek to provide great minds with a dynamic place to nurture new ideas and foster excellence.
Virtusa is an Equal Opportunity Employer. All applicants will receive fair and impartial treatment without regard to race, color, religion, sex, national origin, ancestry, age, legally protected physical or mental disability, protected veteran status, status in the U.S. uniformed services, sexual orientation, gender identity or expression, marital status, genetic information or on any other basis which is protected under applicable federal, state or local law.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government-issued ID during each interview. All candidates must be authorized to work in the USA.
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