LAYI ELLIOT

· Oversaw data queries, based on validation checks or errors and omissions identified during data entry, to resolve identified problems.

· Attended study-specific team meetings and produced status reports and requested metrics, which may include query information or data trends.

· Analyzed clinical data using statistical tools to identify informational trends.

· Liaised with CRO data managers on DM activities and making sure timelines are updated.

· Performed coding of verbatim terms such as adverse events and concomitant medications.

· Sponsor QC/UAT of CRF.

· Tailored data management plans to specific projects to effectively reach deadlines.

· Provided updates on risks, concerns, and challenges of data collection processes for studies

· Worked efficiently to incorporate core clinical team input and produce CRFs on time.

· Reviewed study-specific electronic or paper Case Report Forms (CRFs) with the CRO DM team using prior knowledge, protocol-specific information, and departmental standards.

· Internal team review of DMP, CCG, created by CRO with comments on the issue tracker

· Served as a database manager for the study-specific clinical team, including the compilation of edit checks.

· Developed database requirements with the CRO team for use by EDC vendors.

· Served as a study database manager and worked with CRO/vendors to obtain deliverables promptly.

· Collaborated with medical scientists for coding, consistency, review, and approval, incorporating coding files into the clinical database.

Part of the electronic data capture (EDC) system design and validation team, including oversight of all database specifications eCRF design, edit checks, external data trans Participated in the development of new processes or revision of existing processes.

· Trained internal colleagues in clinical data management in either informal or formal settings as needed.

· Worked cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.

· Provided data management expertise and support to the clinical teams using data management best practices.

· Provided analytical insight on data management strategies and advised the internal team with tactical strategies accordingly.

· Created and/or reviewed study-specific data management and database documentation, which include data management plan, CRF completion guidelines, coding guidelines, annotated CRFs, edit check specifications. IWRS integration, etc.).

· As necessary, provided work direction, guidance, mentoring, influence, and support to junior staff. Trained junior staff in more complex clinical data management processes.

· Ensured compliance with SOPs, GCP, and ICH guidelines and global drug registration standards. Evaluated research data to comply with the plans

· Aided in data submission to regulatory entities and sponsors and prepared detailed reports as requested by the team

Supported DM functional leadership to deliver quality and timely data in a manner that enhanced the integrity, speed, and outcomes of the trial.

· Interfaced with the project team and sponsors across the lifecycle of the project to proactively ensure data integrity and quality.

· Ensured compliance with standard operating procedures.

· Implemented data management plans (DMPs), data validation plans (DVPs), and other study documents.

· Maintained a positive working relationship with fellow staff and management.

· Created and maintained data transfer agreements with external vendors and led external data cleaning activities.

· Followed-up with the project team to answer questions, to ensure data timeliness and cleanliness, and to process and follow queries to closure.

· Conducted and oversaw completion of all activities for database lock, ensuring data integrity and adherence to applicable regulations.

· Ensured all study materials are finalized in an eTMF and archived for delivery.