[Hiring] Clinical Data Manager @Emmes

Role Description

The Clinical Data Manager (CDM) oversees the collection, processing, and management of clinical trial data. The CDM ensures that data is accurate, complete, and verifiable according to protocol specifications, regulatory requirements (e.g., FDA, EMA), and Good Clinical Practice (GCP) guidelines.

• 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, e.g., 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, e.g., 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.
• Perform other duties as assigned.
• Comply with all policies and standards.

Qualifications

• Bachelor's Degree in Life Sciences, Health Information Management, Computer Science, or related field. Required.
• Master's Degree in Life Sciences, Health Information Management, Computer Science, or related field. Preferred.
• 4-6 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.
• Proficiency in EDC systems such as Medidata Rave, Veeva, InForm. High.
• Familiarity with data standards such 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.

Company Description

At Emmes Group, we’re shaping the future of clinical research—where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.

Through our two business units—Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions—we are modernizing clinical trials and accelerating the development of life-changing therapies. We believe that every clinical breakthrough starts with people—people who are passionate, purpose-driven, and ready to make an impact.

Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability.