A CDA is accountable for proper capturing, recording, documenting of clinical research data for clinical study and for validation.  A CDA must make sure that the clinical studies and/or clinical study protocols are completed consistently, as well as making sure they are verifiable clinical data that must exist to back-up the research.

We expect from a CDA:

• To coordinate with clinical research staff in order to accurately collect and record clinical data
• To supervise internal and outsourced clinical data management processes
• To carry-out study specific procedures that abide with regulatory and internal operating procedures
• To design, record, implement, validate and manage clinical data collection and reporting methods
• To create tools to track data
• To perform training for the use of technical software for clinical staff
• To ensure completeness, correctness and consistence of routine clinical data and data structure
• To assist in developing the data transfer specifications, the data mapping specifications, data quality review plan and data validation specifications
• To assist in data review and data reconciliation
• To identify, track and resolve routine queries
• To utilize routine reports to track study progress
• To ensure study timelines and quality expectations are met

Required skills:

• Previous experience as clinical data associate, preferably in CRO setting
• Good communication, interpersonal and team work skills
• Knowledge of operating procedures
• Comprehensive understanding of drug development process and/or device development process
• Knowledge of medical terminology
• Ability to compile, evaluate and examine clinical data
• Ability to correctly apply data to clinical issues
• Robust understanding of database coding aspects and clinical data management methods
• Should be able to handle several projects at the same time
• Able to work together with other clinical team members at Clinitude
• Standard Microsoft knowledge

Minimum required education:

The ideal candidate should have a bachelor degree in life sciences, familiar with or have computer science training/education and a minimum of 2 years of relevant clinical data management experience, preferably in a CRO setting.