Offer summary

Qualifications:

Minimum of 6 months study management or equivalent clinical experience, Proven organizational skills and ability to prioritize tasks, Excellent oral and written communication skills, Strong customer service skills..

Key responsibilities:

Monitor and verify deviation reporting from the conduct team for accuracy and compliance

Assist in the review and approval of study-specific spreadsheets

Support the creation of materials for protocol deviation review meetings

Provide training and support to new clinical staff regarding protocol deviations.

Job description

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

The Clinical Data Deviation Analysis will support our need for integrity and accuracy of data collected during clinical trials in the Celerion clinics through the reporting of non-compliance to Celerion’s SOPs and protocol requirements. They will monitor and verify deviation reporting from the conduct team, ensuring entry and consistency in reporting. They will support compliance initiatives and assist research for quality event investigations as requested.

Essential Functions

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.

Knowledge, Skills, Education, Licenses

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

Celerion Values: Integrity Trust Teamwork Respect

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

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