Lead / Senior Functional Consultant - Life Sciences

EPAM Systems India Pvt Ltd; Hyderabad; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

EPAM Systems India Pvt Ltd in Hyderabad seeks a Lead / Senior Functional Consultant to drive IT solutions for Life Sciences, focusing on clinical operations, data management, and platform optimization. You will lead cross-functional teams to design, deploy, and enhance CTMS, EDC, and eTMF ecosystems, ensuring regulatory compliance and data integrity.

The role requires deep domain experience in clinical IT, data management, and R&D processes, with strong emphasis on AI adoption and analytics for

Qualifications

• 6–14 years of experience in clinical IT systems and operations.
• Myriad experience in clinical data management and trial operations.
• Exposure to regulated environments (GxP, 21 CFR Part 11) and global standards.

Responsibilities

• Define and drive IT solutions for clinical trial ops, study design, recruitment, monitoring and reporting.
• Design, deploy and optimize platforms like CTMS, EDC, and eTMF.
• Lead data migration, harmonization and integration across clinical systems.
• Ensure adherence to global regulatory frameworks and partner with cross-functional teams.

Skills

Clinical IT

CTMS

EDC

eTMF

Data integration

APIs

Cloud platforms

Analytics tools

GxP compliance

AI/ML in clinical

Education

Bachelor's degree in Computer Science/IT/Life Sciences

Tools

CTMS

EDC

eTMF

Job description

# Lead / Senior Functional Consultant - Life SciencesOffice in HyderabadBusiness Consulting, Clinical TrialsAI ArchitectDirector - Delivery ManagementLead Software Engineer - PythonSenior Data ModelerSenior Software Engineer - SAP CAP, NodeJSLead Developer - Microsoft Dynamics 365Senior Software Engineer - Java Full Stack (ReactJS)Senior Data Software EngineerLead Software Engineer - Java Full Stack AngularSenior Developer for Microsoft Dynamics 365We 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, 21 CFR 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 engagementRequirements* 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