Clinical Data Reviewer

Job Summary

We are seeking a diligent Data Quality Specialist to join our team. This role involves reviewing subject and site data for assigned clinical trial sites, identifying insights and potential risks, and facilitating proactive investigations and mitigative actions.

• Proactively review necessary systems, dashboards and reports, and assess data to identify site and subject-level risks

• Convert findings into documented actionable insights for CRAs and collaborate with CRAs to facilitate timely and appropriate resolution of issues.

• Document findings and propose actions, including recommended investigation and follow-up action with the site, as outlined in the study-specific Monitoring Plan

• Work closely with CRAs, project delivery and other study team members to build productive working relationships.

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification

• 2 or more years of experience in a clinical trial environment with preference for clinical data review experience

• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role

• Excellent understanding of clinical trial and operational data.

• Proficiency in working with diverse systems including Excel, dashboards, and other tools.

• Ability to review data and apply critical thinking skills to proactively identify risk

• Strong communication, collaboration and influencing skills to convey findings and drive quality actions

• Ability to identify and escalate issues, determine causes, and develop recommendations to prevent recurrence.

• Advanced organizational and time management skills.

• Flexibility and adaptability in a wide range of scenarios.

This role is performed in an office or home office environment with exposure to electrical office equipment.

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds.

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with proficiency.

On rare occasions, may have exposure to potentially hazardous elements.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.