Lead / Senior Functional Consultant - Life Sciences

Epam Systems; Hyderabad; On-site; INR 1,200,000 - 2,600,000; Full time

Benefits offered by this job

Certifications in clinical IT tools

Job summary

EPAM Systems in India seeks an experienced Lead/Senior Functional Consultant to drive IT solutions for Life Sciences, focusing on clinical trial operations, data management, and regulatory compliance. You will collaborate with cross-functional teams to design, deploy, and optimize platforms like CTMS, EDC, and eTMF while enabling AI-driven insights and advanced analytics.

You will lead data migration, harmonization, and integration across systems, ensuring adherence to global standards and

Qualifications

• Bachelor's degree in Computer Science, IT, or Life Sciences/Pharma fields.
• 5-12 years of experience in clinical IT systems and operations, data, or domain roles in R&D.
• Hands-on background in pharmaceutical clinical IT, data, and operations.
• Strong understanding of the end-to-end clinical trial lifecycle and data management.
• Expertise in CTMS, EDC, and eTMF; proficiency with data integration and cloud analytics.
• Exposure to AI/ML applications in clinical research and portfolio optimization.

Responsibilities

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

Skills

Clinical IT systems

Data management

Regulatory compliance

Cross-functional collaboration

Communication

Problem solving

AI/ML exposure

Education

Bachelor's degree in Computer Science / Life Sciences

Tools

CTMS

EDC

eTMF

APIs

Cloud platforms

Analytics tools

Job description

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, 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 engagement

Requirements

• Bachelor's degree in Computer Science, IT, or any related field in Life Sciences / Pharma areas
• 5-12 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