Remote Data Validation Specialist

Data Validation Specialist Our company specializes in enabling clinical trials research through advanced technologies and neurocognitive measurement. We combine innovative science and technology to advance and improve the clinical trials process for many leading pharmaceutical companies. We are searching for a Data Validation Specialist who will work with other data management team members to test data deliverables to ensure high quality standards.

ESSENTIAL JOB FUNCTIONS

Work with other team members to write, execute and document the results of validation testing that is completed for data management deliverables including data transfers, data flags and reports.

Communicate issues identified during testing to department staff to resolve the issue.

Assist in the development and execution of SOPs, departmental guidelines and data standards to guarantee database quality control and data management compliance.

Document, verify, and validate regulatory-compliant programs to perform data management activities.

Engage in project planning to ensure timely commencement of database design and data checks.

Support teams to capture data using eCOA and ePRO solutions.

Assist in the development of requirements of data checks and reports to guarantee high data quality.

Coordinate with project, scientific, and statistics staff in clinical trial databases’ design, development, testing and documentation.

Use problem solving and judgment to apply Clinical Data Management principles.

Update new technology developments and comply with clinical data management-associated regulatory issues.

Enter and compile data to generate and develop summary reports and graphics.

Other duties as assigned.

QUALIFICATIONS

BA/BS degree or equivalent degree or applicable industry related experience

Experience working with eCOA, ePRO, eDC or similar systems preferred

Basic knowledge of ICH, FDA, GCP and other relevant regulations/guidelines preferred

Strong communications and interpersonal skills

Ability to pay close attention to detail

Experience testing data checks and reports preferred