Clinical Data Coordinator

Senior Clinical Data Coordinator (CDC)

Job Location: Remote working

Experience: 5+ years

Key Accountabilities

• Performs data management tasks according to applicable SOPs (standard operating procedures) and processes.

These activities may include the following categories:

Data Review

• Performs data review of clinical trial data, including query management
• Performs reconciliation review of external data against EDC data
• May assist in creating study documents or assist in running study reports and metrics
• Performs additional review activities for interim and final database locks as needed.

Documentation & Filing

• Files study documentation in electronic Trial Master File (eTMF) and department project files.
• Performs periodic quality review of eTMF documents.
• Assists with taking meeting minutes and documenting/tracking study data management activities.
• Performs data archival activities.
• Performs inspection readiness activities and supports CDM team during internal and regulatory inspections

Data Collection Systems

• May support the set-up and testing of study data collection tools.

Additional Activities

• Assists with quality review of above activities performed by the CRO, as needed.
• Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
• Performs other duties as assigned.

Educational Qualifications

• Associate or bachelors Degree preferred

Experience

• Ideally 5+ or more years relevant work experience, or equivalent combination of experience in Clinical Data Management.
• Strong hands-on with Veeva EDC (electronic data collection) systems
• Strong hands-on with Veeva CDMS
• Experience with UAT Systems tools
• Preferred knowledge of data management best practices & technologies as applied to clinical trials.
• Preferred knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.

Special Skills/Abilities

• Strong attention to detail, and organizational skills
• Good time management skills
• Quick learner and comfortable learning new technologies and systems
• Good knowledge of office software (Microsoft Office).