Sr. Associate, Basic Results Author

ROLE SUMMARY The Clinical Trial Results Author is responsible for the preparation, authoring, review, and maintenance of clinical trial results disclosures for public registries including ClinicalTrials.gov, the Clinical Trials Information System (CTIS), and EudraCT.

The role works closely with Clinical Trial Disclosure Managers, Clinicians, Statisticians, Programmers, Medical Writing, and Study Teams to ensure timely, accurate, and compliant disclosure of clinical trial results. The individual authors Basic Results (BR) by transforming clinical study data and statistical outputs into compliant results records while ensuring adherence to applicable regulations, quality standards, and standard operating procedures.

ROLE RESPONSIBILITIES · Author ClinicalTrials.gov Basic Results records in PRIME. · Prepare and maintain: o Participant Flow o Baseline Characteristics o Outcome Measures o Adverse Events o Limitations and Caveats o Certain Agreements and Results Point of Contact sections. · Review source documents including Protocol, SAP, CSR, and statistical tables as supporting documents for preparing basic results. · Work with Cross functional groups Clinical trial disclosure manager, clinicians, legal and statisticians for preparing basic results to resolve data questions and ensure accuracy. · Address quality review comments and support responses to ClinicalTrials.gov reviewer comments. · Ensure results are completed within disclosure timelines and in compliance with regulatory requirements. · Support process improvements, training materials, and authoring best practices. · Maintain audit-ready documentation and evidence. · Ensure compliance with: o FDAAA 801 o 42 CFR Part 11 o EU CTR 536/2014 o EU CTD 536/2014 o Internal disclosure procedures.