Lead / Senior Functional Consultant - Life Sciences
EPAM Systems · State of Telangāna, India
EPAM Systems · State of Telangāna, India
*EPAM is a leading global provider of digital platform engineering and development services. We are committed to having a positive impact on our customers, our employees, and our communities. We embrace a dynamic and inclusive culture. Here you will collaborate with multi-national teams, contribute to a myriad of innovative projects that deliver the most creative and cutting-edge solutions, and have an opportunity to continuously learn and grow. No matter where you are located, you will join a dedicated, creative, and diverse community that will help you discover your fullest potential.* 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 **Nice to have** - Certifications in clinical IT tools **We offer** - Opportunity to work on technical challenges that may impact across geographies - Vast opportunities for self-development: online university, knowledge sharing opportunities globally, learning opportunities through external certifications - Opportunity to share your ideas on international platforms - Sponsored Tech Talks & Hackathons - Unlimited access to LinkedIn learning solutions - Possibility to relocate to any EPAM office for short and long-term projects - Focused individual development - Benefit package: - Health benefits - Retirement benefits - Paid time off - Flexible benefits - Forums to explore beyond work passion (CSR, photography, painting, sports, etc.)