Clinical Data Deviation Analyst

Summary

Join Celerion as a Clinical Data Deviation Analyst and contribute to the integrity and accuracy of clinical trial data. You will monitor and verify deviation reporting, ensuring consistency and compliance with SOPs and protocols. Responsibilities include daily data review, identification of protocol variances, support for protocol review, and assistance with quality event investigations. You will also contribute to risk mitigation plans, support the creation of materials for deviation review meetings, and provide training to clinical staff. The role requires strong organizational skills, excellent communication, and the ability to manage multiple priorities. This position offers the opportunity to support compliance initiatives and contribute to the efficient advancement of drug development.

Requirements

• Minimum of 6 months study management or equivalent clinical experience
• Proven organization skills and ability to prioritize
• Ability to manage multiple priorities
• Excellent oral and written communication skills
• Ability to work without close supervision
• Ability to work hours required which might vary from week to week
• Strong customer service skills

Responsibilities

• Data Monitoring and Verification: Daily review of IDNTs, programmable edit checks, and data queries for identification, entry, and reporting as observations, quality deviations, or protocol deviations
• Identification of protocol and Sponsor variances to Celerion standard processes and ranges
• Support protocol review to prevent deviations
• Assist with the review and approval of study specific spreadsheets on behalf of the CSM
• Contribute to the development of a plan to mitigate any risks and/or reporting requirements via attendance a study award meeting to support the team in identifying potential risks and variances to standard processes
• Identify, request, and review programmable deviations
• Support the creation/preparation of materials for the protocol deviation review meeting occurring at database lock
• Ensure that all protocol deviations are completed and Veeva is locked for future updates, following the completion of the COV
• Provide training and support to new clinical staff on questions around protocol deviations and handling
• Support research and requests for information to assist in Quality Events
• Recommend corrective actions for study trends when possible or known
• Support compliance with Regulatory and SOP within Celerion through identification, education, and tracking
• Creation, testing, and support of eCOA survey development and study schedule set up
• Assistance with eCOA where requested