Clinical Data Manager

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

Clinical Data Manager

Overview

Note for Applicants

This position will begin as a full-time temporary assignment scheduled for 40 hours per week. The assignment is currently anticipated to continue roughly 6 months, though timelines may change based on business needs and project demands. Depending on business needs, funding, and individual performance, there may be future consideration for extension or conversion to a regular full-time employee position. Conversion or extension is not guaranteed.

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) 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.

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.

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