About this opportunity
The Emmes Company, LLC lists this Clinical Data Manager opportunity in rockville, Maryland. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Overview
Clinical Data Manager
Location: Remote
About This Opportunity: This is an evergreen position intended to help us identify and engage with talented professionals for potential future hiring needs. While there may not be an immediate opening or approved requisition associated with this posting, we encourage interested candidates to apply. Should a suitable opportunity become available, qualified applicants may be contacted regarding next steps.
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:
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.