Associate Clinical Data Manager

Emmes Group is hiring an Associate Clinical Data Manager to assist with data management activities for research studies. The role supports cross-functional teams throughout the study lifecycle and helps ensure study data is complete and accurate in electronic databases.

Responsibilities

Assists cross functional teams with the documentation, testing, and implementation of clinical data collection studies in an electronic data capture EDC system

Contributes to design and/or development of study specific electronic or paper Case Report Forms (CRFs), utilizing study protocol and clinical requirements

Assists the project team and other study personnel to determine data collection requirements based on the study protocol

Assists with documenting and resolving data management issues in conjunction with the DM team

Assists with review, implementation, and evaluation of data validation processes, example, edit checks

Utilizes study data management documents, example, Data Management Handbook, Data Management Plan, Data Validation Plan, EDC System User's Guide, EDC Training and Certification Documents

Assists with reviewing data obtained through Electronic Medical Records EMR integration, EDC systems, or other external data sources

Attends and participates in project and department meetings as required

Assists with identification and resolution of data queries and discrepancies, assists with data quality audits

Assists with training users on the EDC system and protocol specific EDC requirements, maintains related training documentation and supports system user access

Assists with preparation of data reports as applicable

Performs other duties as assigned

Complies with all policies and standards

Preferred

less than 1 year Experience assisting in the design, development, and implementation of study-specific CRFs (electronic or paper)

less than 1 year Familiarity with clinical study protocols, data validation processes, and query resolution

less than 1 year Exposure to cross-functional team collaboration in clinical research settings

less than 1 year Experience with reviewing data from EMR integration, EDC systems, or other external data sources

less than 1 year Basic experience providing training and support for EDC users and documenting related activities

less than 1 year Knowledge of study data reporting, quality audits, and adherence to regulatory and SOP standards

less than 1 year Experience assisting in the design, development, and implementation of study-specific CRFs (electronic or paper).

less than 1 year Familiarity with clinical study protocols, data validation processes, and query resolution.

less than 1 year Exposure to cross-functional team collaboration in clinical research settings.

less than 1 year Experience with reviewing data from EMR integration, EDC systems, or other external data sources.

less than 1 year Basic experience providing training and support for EDC users and documenting related activities.

less than 1 year Knowledge of study data reporting, quality audits, and adherence to regulatory and SOP standards.

CRF Design

CRF Implementation

Clinical Study Protocols

Data Validation

Query Resolution

EMR Data Integration

EDC Systems

External Data Review

EDC User Training

EDC User Support

Activity Documentation

Study Data Reporting

Quality Audits

Regulatory Compliance

SOP Compliance

Cross-Functional Collaboration

Benefits

Remote work arrangement

Company

Specialty CRO providing clinical trial services and technology solutions

Rockville, Maryland, USA

https://theemmesgroup.com/

Founded in 1977

1001-5000 employees

Qualifications

Bachelor's Degree Public health, clinical, science, technical, or related discipline; equivalent combination of education and relevant work experience may be considered in lieu of a degree

1-3 years of experience in clinical data management, electronic data capture (EDC), or related clinical research role

Excellent verbal and written communication skills

Skills in prioritization, organization, and time management

Strong attention to detail, adaptable, and flexible

Knowledge of Microsoft Office suite is essential

Less than 1 year Experience assisting in the design, development, and implementation of study-specific CRFs (electronic or paper)

Less than 1 year Familiarity with clinical study protocols, data validation processes, and query resolution

Less than 1 year Exposure to cross-functional team collaboration in clinical research settings

Less than 1 year Experience with reviewing data from EMR integration, EDC systems, or other external data sources

Less than 1 year Basic experience providing training and support for EDC users and documenting related activities

Less than 1 year Knowledge of study data reporting, quality audits, and adherence to regulatory and SOP standards

1-3 years of experience in clinical data management, electronic data capture (EDC), or related clinical research role.

Required skills

Clinical data management, Electronic Data Capture (EDC), Case Report Forms (CRFs), Clinical study protocols, Data validation, Query resolution, Electronic Medical Records (EMR) integration, Data quality audits, Regulatory and SOP standards, Microsoft Office

Preferred skills

Verbal and written communication

Experience

1-3 years