Lead / Senior Functional Consultant - Life Sciences

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