Lead / Senior Functional Consultant - Life Sciences

EPAM Systems; India; On-site; INR 2,500,000 - 7,000,000; Full time

Job summary

EPAM Systems in India seeks a Lead / Senior Functional Consultant to drive IT solutions in Life Sciences, focusing on clinical trial operations and data management. You will collaborate with cross-functional teams to design, deploy, and optimize clinical platforms while ensuring regulatory compliance across global frameworks.

You will lead efforts in AI adoption, advanced analytics, data integration, and digital health tools for trial optimization, working with CTMS, EDC, and eTMF platforms.

Qualifications

• Bachelor’s degree in Computer Science, IT, or Life Sciences/Pharma fields.
• 6–14 years in clinical IT systems, data management or related R&D roles.
• Hands-on background in pharmaceutical clinical IT, data and operations.
• Strong understanding of end-to-end clinical trial lifecycle and data management.
• Expertise with CTMS, EDC, and eTMF; regulatory compliance experience.
• Experience with data integration, APIs, and cloud analytics tools.
• Exposure to AI/ML applications in clinical research and portfolio optimization.
• Excellent communication and stakeholder management skills.

Responsibilities

• Define and drive IT solutions aligned with clinical trial ops, study design, recruitment, monitoring, and reporting.
• Design, deploy, and optimize CTMS, EDC, eTMF, and clinical data hubs.
• Lead data migration, harmonization, and integration across clinical systems.
• Ensure adherence to ICH‑GCP, 21CFR Part 11, GDPR, HIPAA, and global standards.
• Collaborate with clinical operations, biostatistics, regulatory, and IT teams end-to-end.
• Drive AI adoption and advanced analytics for trial optimization and patient engagement.

Skills

Clinical IT systems

Regulatory frameworks

Data management

End-to-end clinical trial lifecycle

Communication

Stakeholder management

Problem solving

AI/ML in clinical research

Cloud platforms

APIs

Education

Bachelor’s degree in Computer Science, IT, or Life Sciences / Pharma

Tools

CTMS

EDC

eTMF

APIs

Cloud platforms

Analytics tools

Job description

Job Overview

We are seeking an experienced Lead / Senior Functional Consultant to drive IT solutions within the Life Sciences domain, with a strong focus on clinical trial operations and data management. In this role, you will partner with cross‑functional teams to design, deploy, and optimize clinical platforms while ensuring compliance with global regulatory frameworks and leveraging emerging technologies such as AI and advanced analytics.

Responsibilities

• Define and drive IT solutions aligned with clinical trial operations, study design, patient recruitment, monitoring, and reporting.
• Design, deploy, and optimize platforms such as CTMS, EDC, eTMF, and clinical data hubs.
• Lead data migration, harmonization, and integration across clinical systems.
• Ensure adherence to ICH‑GCP, 21CFR Part 11, GDPR, HIPAA, and other global regulatory frameworks.
• Partner with clinical operations, biostatistics, regulatory, and IT teams to deliver end‑to‑end solutions.
• Drive AI adoption, advanced analytics, and digital health tools for trial optimization and patient engagement.

Required Qualifications

• Bachelor’s degree in Computer Science, IT, or any related field in Life Sciences / Pharma areas.
• 6‑14 years of experience in clinical IT systems and operations, clinical data, clinical consulting, or domain roles in R&D.
• Deep, hands‑on background in pharmaceutical clinical IT, data, and operations (e.g., Clinical Operations, Study Management, Trial Oversight, or related functions).
• Strong understanding of the end‑to‑end clinical trial lifecycle (protocol design, site activation, patient recruitment, monitoring, reporting) and data management.
• Expertise in IT tools such as CTMS, EDC, and eTMF.
• Proficiency in data integration, APIs, cloud platforms, and analytics tools.
• Familiarity with FDA, EMA, and global compliance standards, including demonstrated experience working within regulated environments (GxP, clinical compliance).
• Exposure to AI/ML applications in clinical research and portfolio optimization.
• Exceptional communication, stakeholder management, and problem‑solving abilities, with the capability to explain complex analytical concepts to non‑technical stakeholders.

Nice to Have

• Certifications in clinical IT tools.