Specialist, Clinical Data Reporting

Randstad; Hyderabad; Hybrid; INR 900,000 - 1,500,000; Full time

Job summary

Randstad in India is seeking a data reporting specialist to program and maintain standardized clinical data reports used for participant-level data review and operational oversight. You will translate study reporting requirements into technical specifications and implement outputs using established frameworks and data standards.

Working with CDM and technology teams, you will build validation outputs and performance reports, leverage EDC and data sources, and ensure audit-ready documentation in

Qualifications

• Bachelor's or Master's degree in a relevant field.
• 2+ years in clinical data, data visualization, or related discipline.
• Proficiency with EDC systems and analytics tools like SAS, R, Python, Tableau, Power BI.
• Strong knowledge of CDISC, GCP, GDPR, and HIPAA requirements.

Responsibilities

• Program and maintain standardized clinical data reports and listings for data review, cleaning, and oversight.
• Translate study reporting requirements into technical specifications and implement outputs using established frameworks.
• Build and validate data review listings, reconciliation outputs, and operational performance reports.
• Communicate with cross-functional partners to clarify reporting needs and deliver outputs on schedule.
• Partner with CDM and technology teams to leverage data sources including EDC, data lakes, and external streams.
• Monitor routine data refreshes, troubleshoot data accuracy, and contribute to automation and workflow improvements.
• Keep reporting documentation audit-ready in line with GCP, ICH, GDPR, SOPs, and quality standards.

Skills

Data visualization

Cross-functional collaboration

Data quality governance

Clinical data understanding

Education

Bachelor's or Master's in Data Science, Computer Science, Life Sciences, or related field

Tools

SAS

R

Python

JReview

Tableau

Power BI

Spotfire

Medidata RAVE

Job description

Role & responsibilities

• Program and maintain standardized clinical data reports and listings used for participant-level data review, data cleaning, and operational oversight
• Translate study reporting requirements into technical specifications and implement outputs using established frameworks and data standards
• Build and validate data review listings, exception reports, reconciliation outputs between EDC and external data, and operational performance reports
• You communicate clearly with cross-functional partners to clarify reporting needs and deliver outputs on schedule
• Partner with clinical data management and technology teams to leverage data sources including the Scientific Data Lake, EDC systems, and external data streams
• Monitor routine data refreshes, troubleshoot issues with accuracy, completeness, and integration, and contribute to automation and workflow streamlining
• Keep reporting documentation, specifications, and outputs audit- and inspection-ready in line with GCP, ICH, GDPR, SOPs, and internal quality standards
• You stay curious about reporting tools and methodologies, sharing knowledge of standards and processes to support team learning and continuous improvement

Preferred candidate profile

• Bachelor's or Master's degree in Data Science, Computer Science, Life Sciences, or a related field
• 2+ years of experience in clinical data, data visualization, or related disciplines, with a background in building interactive reporting solutions, KPIs, and metrics to support clinical trial oversight
• Proficiency in EDC systems (e.g., Medidata RAVE) and analytics, reporting, and data visualization tools such as SAS, R, Python, JReview, elluminate, Tableau, Power BI, or Spotfire
• Strong understanding of clinical trial processes, clinical data standards (e.g., CDISC), and regulatory requirements (GCP, GDPR, HIPAA)
• Experience with risk-based data review concepts, data quality standards, and data lifecycle management in a regulated environment
• Experience with data lakes, data pipelines, data integration, automation, and reporting and analytics in a clinical research environment