Clinical Data Handling

Why This Role Matters
Clinical data transformation and governance are critical to accelerating drug development while maintaining GxP compliance. As a Lead R&D Technologist at ZS, you will design and implement technology-driven solutions that improve clinical data management, analytics, and decision-making across global drug development programs.

Job Description
ZS is hiring a Lead R&D Technologist within its Life Sciences R&D division. The role focuses on Clinical Data Management, data transformation, analytics platforms, and regulatory-compliant solution architecture. You will act as a techno-functional consultant bridging business, regulatory, and engineering teams.

Key Features of the Role:
• Location: Pune or Gurgaon, India
• Practice: Medical & Scientific – Drug Development
• Experience: 6–10 years
• Hybrid model (3 days onsite, 2 remote)
• Client-facing role with travel requirement
• GxP-regulated program exposure

Responsibilities
• Design and implement Clinical Data Management and Analytics solutions
• Lead requirement gathering workshops and stakeholder discussions
• Define user stories, acceptance criteria, and RTMs
• Develop solution architectures and data flow models
• Translate regulatory and clinical requirements into scalable systems
• Support Clinical Data Repository (CDR) implementations
• Guide Agile ceremonies and backlog refinement
• Mentor junior analysts and consultants
• Ensure compliance with CDISC, FHIR, OMOP standards
• Support delivery in large enterprise GxP programs

Required Qualifications
• Bachelor’s degree in Pharmacy, Life Sciences, Bioinformatics, Medicine, or related field
• 6–10 years experience in Life Sciences / Pharma domain
• Experience as Business Analyst, Clinical Data Consultant, Solution Architect, or Data Analyst

Preferred Qualifications
• Master’s degree in Business Analysis, Engineering, Data/Computer Science
• Experience in CDR end-to-end implementations
• Exposure to R, Python, or SAS

Technical Expertise
• EDC tools: Rave, Veeva, InForm, OpenClinica
• Clinical Data Repositories: SAS LSAF, Oracle LSH
• Metadata Repositories: Nurocor, Sycamore, Formedix
• Statistical environments: SAS Viya, Domino
• RBQM systems
• Deep understanding of CDISC, FHIR, OMOP standards
• Data transformation, conformance, automation

Experience and Skills:
• Strong knowledge of end-to-end clinical data lifecycle
• Experience delivering GxP-compliant enterprise solutions
• Clinical data governance and access control expertise
• Stakeholder management and consulting capability
• Cross-functional collaboration skills
• Analytical and solution design thinking

Salary Insights
Salary not disclosed (expected competitive package aligned with senior consulting role in Life Sciences domain).

Hybrid Working Model
• 3 days onsite (client or ZS office)
• 2 days remote
• Travel required based on client needs

Growth Opportunities
• Cross-functional skill development
• Structured milestone training programs
• Internal mobility pathways
• Exposure to global R&D transformation initiatives

FAQs

Q1 Is travel required?
Yes, travel is expected for client-facing projects.

Q2 Is GxP experience mandatory?
Yes, experience in regulated GxP environments is important.

Q3 Is programming knowledge required?
Exposure to R, Python, or SAS is preferred but not mandatory.

Q4 What standards should candidates be familiar with?
CDISC, FHIR, OMOP, and clinical data management standards.

Q5 Is this a pure technical role?
No, it is a techno-functional consulting role combining strategy, analysis, and technology implementation.

Application Tips
• Highlight end-to-end Clinical Data Repository experience
• Mention specific EDC/CDR tools worked on
• Demonstrate experience translating regulatory requirements into solutions
• Emphasize stakeholder engagement and Agile experience
• Include transcripts as required in the application process