Clinical Data Manager

Emmes Group•Rockville, MD

7d•Onsite

About The Position

The Clinical Data Manager (CDM) will 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. Emmes Group is shaping the future of clinical research, combining human intelligence with cutting-edge technology to drive advancements in healthcare. With over 47 years of scientific excellence, they have led research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. Through their business units, Emmes (a full-service CRO) and Veridix AI (technology, data, and analytical solutions), they are modernizing clinical trials and accelerating the development of life-changing therapies. Their culture is built on integrity, collaboration, and innovation.

Requirements

Bachelor's Degree Life Sciences, Health Information Management, Computer Science, or related field. Required
4-6 years -3 6 years of experience in clinical data management (pharmaceutical, CRO, or biotech experience preferred). Required
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

Nice To Haves

Master's Degree Life Sciences, Health Information Management, Computer Science, or related field. Preferred
1-3 years Prior experience with EDC systems and CDISC standards (SDTM/ADaM) preferred. Preferred

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