Clinical Data Integrity Specialist

We are seeking a skilled professional to play a key role in ensuring the quality and integrity of clinical trial data.

Job Description

The ideal candidate will be responsible for conducting thorough risk assessments, identifying potential issues and developing mitigation strategies.

This includes performing centralized statistical monitoring and data analysis on study data to detect anomalies, trends and potential risks.

• Key responsibilities include :
• Study Risk Assessment : Conduct thorough risk assessments for clinical studies.
• Centralized Statistical Monitoring : Perform centralized statistical monitoring & data analysis on study data.
• Data Quality Assurance : Ensure the highest standards of data quality and integrity.

The successful candidate will work closely with various departments to support proactive oversight and management of data cleaning for studies.

Required Skills and Qualifications

We are looking for someone with a Bachelor's Degree in a relevant field or relevant / equivalent combination of education, training and experience.

The ideal candidate will have minimum 2 years experience in clinical monitoring, clinical trial management or equivalent.

Excellent communication, organizational and time management skills are essential for this role.

Benefits

This is an excellent opportunity for someone who can communicate effectively with project team members and lead the development of Risk-Based Quality Management (RBQM) plans.

The Central Monitor II will also conduct study risk assessments, identify study Key Risk Indicators (KRIs) and perform ongoing centralized statistical monitoring.

Others

The successful candidate will facilitate monthly RBQM meetings and ensure the highest standards of data quality and integrity.

The job requires close collaboration with clinical operations, data management, biostatistics and other departments.