Clinical Data Manager

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

Overview

Clinical Data Manager

Location: Remote

Be Part of One Team, One Purpose.

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. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact.

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

The Clinical Data Manager (CDM) to oversee 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.

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

Qualifications

• 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
• 4-6 years -3 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. 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

If you’re looking for a career where your work advances global health and where scientific excellence meets real world impact, join us and be part of something bigger. One Team, One Purpose.

CONNECT WITH US!

Find us on LinkedIn:/the-emmes-group/

Visit our website: https://www.theemmesgroup.com/