Clinical Data Manager

Role Overview Emmes Group is a globally recognised contract research organisation with over 47 years of scientific excellence, working at the intersection of human intelligence and advanced technology to transform clinical research. We are looking for a skilled Clinical Data Manager to join our team in Bengaluru and take ownership of the end-to-end management of clinical trial data. In this role, you will ensure that all study data is accurate, complete, and fully compliant with regulatory frameworks including FDA, EMA, and Good Clinical Practice guidelines. Key Responsibilities - Develop, maintain, and review Data Management Plans, data validation specifications, and all study-related documentation - Design and review Case Report Forms and electronic CRFs in coordination with clinical teams and vendors - Oversee the setup, validation, and ongoing maintenance of EDC systems such as Medidata Rave, Oracle InForm, Veeva, and REDCap - Conduct data cleaning activities, generate queries, and resolve data discrepancies in a timely manner - Ensure accurate and timely database lock and data delivery to biostatistics and relevant stakeholders - Coordinate with CROs, EDC vendors, and central laboratories to maintain compliant and timely data workflows - Collaborate with internal teams across clinical, regulatory, biostatistics, and safety functions to align data deliverables with study objectives - Participate actively in study team meetings and contribute to project timelines and risk mitigation strategies - Ensure full compliance with regulatory standards including FDA 21 CFR Part 11 and ICH GCP guidelines - Support audits, data review meetings, and internal quality checks while maintaining inspection-ready documentation Required Qualifications - Bachelor's degree in Life Sciences, Health Information Management, Computer Science, or a related discipline - Master's degree in a relevant field is preferred - Minimum 3 years of experience in clinical data management within a pharmaceutical, CRO, or biotech environment - Hands-on experience with EDC platforms such as Medidata Rave, Veeva, or Oracle InForm - Familiarity with CDISC standards including SDTM and ADaM, along with MedDRA and WHODrug coding - Experience with database lock processes, query management, and edit check programming - Knowledge of SAS, SQL, or other data handling languages is an added advantage - Strong attention to detail, excellent communication skills, and the ability to manage multiple projects simultaneously Why Join Us At Emmes Group, you will be part of a purpose-driven organisation that is advancing global health through scientific innovation and cutting-edge technology. This is your opportunity to contribute to meaningful clinical breakthroughs while growing your career in a collaborative and integrity-focused environment.

- Bachelor's degree in Life Sciences, Health Information Management, Computer Science, or related field - Minimum 3 years of clinical data management experience in pharma, CRO, or biotech - Proficiency in EDC systems including Medidata Rave, Veeva, and Oracle InForm - Knowledge of CDISC standards such as SDTM and ADaM - Familiarity with MedDRA and WHODrug coding dictionaries - Experience with database lock, query management, and edit check processes - Understanding of regulatory requirements including FDA 21 CFR Part 11 and ICH GCP - Knowledge of SAS, SQL, or similar data handling tools is a plus - Strong organisational skills and attention to detail - Excellent interpersonal and communication abilities - Ability to handle multiple projects and meet deadlines effectively

- Opportunity to work with a globally recognised CRO with 47 years of excellence - Exposure to cutting-edge clinical trial technology and data solutions - Collaborative and innovation-driven work culture - Involvement in impactful research across rare diseases, gene therapy, neuroscience, and more