Role & responsibilities

- Develop and maintain data management plans DMPs, data validation specifications, and other study related documents.

- Design and review CRFs eCRFs in collaboration with clinical teams and vendors.

- Oversee the setup, validation, and ongoing maintenance of electronic data capture EDC systems, example, Medidata Rave, Oracle InForm, Veeva, REDCap.

- Perform and review data cleaning, query generation, and issue resolution activities.

- Ensure timely and accurate database lock and data delivery to biostatistics and other stakeholders.

- Coordinate with CROs, EDC vendors, and central laboratories to ensure timely and compliant data activities.

- Liaise with internal teams clinical, regulatory, biostats, safety to ensure alignment of data deliverables with study goals.

- Participate in study team meetings and contribute to project timelines and risk management.

- Ensure compliance with regulatory requirements, example, FDA 21 CFR Part 11, ICH GCP.

- Conduct or support audits, data review meetings, and internal quality checks.

- Maintain accurate and complete documentation for inspection readiness.

- Performs other duties as assigned





- Complies with all policies and standards

Preferred candidate profile

- Bachelor's Degree Life Sciences, Health Information Management, Computer Science, or related field. Required

- Master's Degree Life Sciences, Health Information Management, Computer Science, or related field. Preferred

- 2- 4 years of experience in clinical data management (pharmaceutical, CRO, or biotech experience preferred). Required

- 1-3 years Prior experience with EDC systems and CDISC standards (SDTM/ADaM) preferred. Preferred

- Proficiency in EDC systems as Medidata Rave, Veeva, InForm. High

- Familiarity with data standards as CDISC, MedDRA, WHODrug. High

- Experience with database lock processes, query management, and edit checks. High

- Knowledge of SAS, SQL, or other data handling languages is a plus. High

- Solid attention to detail and organizational skills. High

- Excellent communication and interpersonal abilities. High

- Ability to manage multiple projects and deadlines. High
- team oriented mindset with proactive problem solving skills. High

📌 Clinical Data Manager (Bengaluru)
🏢 Emmes
📍 Bengaluru