Lead / Senior Functional Consultant - Life Sciences

EPAM·India·Офис·вчера

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
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