Clinical Data Manager

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
• Strong 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