Clinical Data Manager - EDC & Data Integrity Lead

Emmes Group; Rockville (MD); On-site; USD 70,000 - 100,000; Full time

Job summary

Emmes Group is seeking a Clinical Data Manager to oversee the collection, processing, and management of clinical trial data. You will ensure data accuracy, completeness, and verifiability in line with protocol specs, FDA/EMA requirements, and GCP guidelines.

The role involves designing CRFs, managing EDC systems, and coordinating with CROs and vendors to ensure timely data delivery and QA for inspection readiness. A strong attention to detail and collaboration skills are essential.

Qualifications

• Bachelor’s degree in life sciences or related field required.
• 4–6 years of clinical data management experience.
• Experience with EDC systems and CDISC SDTM/ADaM preferred.
• Strong communication and organizational skills.
• Ability to manage multiple projects and deadlines.

Responsibilities

• Develop and maintain data management plans and data validation specs.
• Design and review CRFs/eCRFs with clinical teams and vendors.
• Oversee EDC setup, validation, and maintenance (Medidata Rave, InForm, Veeva, REDCap).
• Perform data cleaning, queries, and issue resolution.
• Ensure timely database lock and data delivery to biostatistics.
• Coordinate with CROs, EDC vendors, and labs for data activities.
• Ensure regulatory compliance (FDA, ICH GCP) and QC checks.
• Maintain documentation for inspection readiness.

Education

Bachelor's Degree

Master's Degree

Tools

Medidata Rave

Veeva

InForm

Job description

Emmes Group is seeking a Clinical Data Manager to oversee the collection, processing, and management of clinical trial data. You will ensure data accuracy, completeness, and verifiability in line with protocol specs, FDA/EMA requirements, and GCP guidelines.

The role involves designing CRFs, managing EDC systems, and coordinating with CROs and vendors to ensure timely data delivery and QA for inspection readiness. A strong attention to detail and collaboration skills are essential.