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 RD

- Deep, hands-on background in pharmaceutical clinical IT, data, and operations (e.g., Clinical Operations, Study Management, Trial Oversight, or related functions)

- Solid 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

📌 Lead / Senior Functional Consultant - Life science (Hyderabad)
🏢 EPAM Systems
📍 Hyderabad