Remote Clinical Data Manager — Elevate Trial Data

Emmes; Rockville (MD); Remote; USD 90,000 - 120,000; Full time

Job summary

Emmes is seeking a Clinical Data Manager to oversee the collection, processing, and management of clinical trial data in a remote capacity. The role ensures data accuracy, completeness, and verifiability per protocol, FDA/EMA regulations, and GCP guidelines.

You will design data management plans, review CRFs, manage EDC systems like Medidata Rave, Veeva and REDCap, and coordinate with CROs and labs to ensure timely data delivery and audit readiness.

Qualifications

• Bachelor's degree in Life Sciences, Health Information Management, Computer Science, or related field is required.
• Master's degree is preferred.
• 4–6 years of experience in clinical data management in pharma, CRO, or biotech settings.

Responsibilities

• Develop and maintain data management plans (DMPs) and data validation specifications.
• Design and review CRFs/eCRFs with clinical teams and vendors.
• Oversee EDC systems setup, validation, and maintenance (Medidata Rave, Oracle InForm, Veeva, REDCap).
• Perform and review data cleaning, query generation, and issue resolution.
• Ensure timely database lock and data delivery to biostatistics and stakeholders.
• Coordinate with CROs, EDC vendors, and central labs for data activities.
• Liaise with clinical, regulatory, biostats, and safety teams to align data deliverables with study goals.
• Participate in study team meetings and contribute to timelines and risk management.
• Ensure compliance with FDA 21 CFR Part 11, ICH GCP; conduct audits and quality checks.
• Maintain accurate documentation for inspection readiness.

Education

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

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

Tools

Medidata Rave

Veeva

InForm

CDISC SDTM/ADaM

MedDRA

WHODrug

SAS

SQL

Job description

Emmes is seeking a Clinical Data Manager to oversee the collection, processing, and management of clinical trial data in a remote capacity. The role ensures data accuracy, completeness, and verifiability per protocol, FDA/EMA regulations, and GCP guidelines.

You will design data management plans, review CRFs, manage EDC systems like Medidata Rave, Veeva and REDCap, and coordinate with CROs and labs to ensure timely data delivery and audit readiness.