Note: The job is a remote job and is open to candidates in USA. Emmes Group is a clinical research organization and technology company advancing clinical research and global health. The Clinical Data Manager oversees the collection, processing, validation, and management of clinical trial data, ensuring accuracy, completeness, regulatory compliance, and adherence to Good Clinical Practice. The role also coordinates data activities with internal teams, CROs, vendors, and laboratories through database lock and delivery.
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
Skills
- Bachelor's Degree Life Sciences, Health Information Management, Computer Science, or related field. Required
- 4-6 years -3 6 years of experience in clinical data management (pharmaceutical, CRO, or biotech experience preferred). Required
- 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
- Master's Degree Life Sciences, Health Information Management, Computer Science, or related field. Preferred
- 1-3 years Prior experience with EDC systems and CDISC standards (SDTM/ADaM) preferred. Preferred
Benefits
- US Remote
Company Overview
Company H1B Sponsorship