Jennifer Cliff Email & Phone Number

• Manages the clinical data management process for multiple clinical trials, ensuring data accuracy and timeliness.• Designs comprehensive Case Report Forms (CRFs) and CRF Completion Guidelines (CCGs) that adhere to regulatory standards and Good Clinical Practice (GCP).• Generates comprehensive patient and study metric reports tracking key performance indicators and data cleaning progress.• Orchestrates the reconciliation of various external data sources each month.• Provides support to the Clinical Research Coordinators (CRCs), Clinical Research Associates (CRAs) and other site personal regarding study related questions.• Executes comprehensive Serious Adverse Event (SAE) reconciliation.• Coordinates the MedDRA and WhoDrug dictionary coding.• Assists with SAS programming and quality control of SAS programs used by the data management department.• Performs database lock activities as specified in DMP.

•Served as Lead Data Manager or supported the Lead Data Manager in all aspects of the clinical data management process from study start up activities to database lock.•Reviewed study data via edit check output, SAS data listings, and manual review.•Ensured the required study-specific documents were filed in the Trial Master File (TMF).•Provided support to the Clinical Research Coordinators (CRCs), Clinical Research Associates (CRAs) and other site personal regarding study-related questions.

•Supported the Lead Data Manager in all aspects of the clinical data management process ensuring continuity, responsiveness, and accuracy.•Reviewed edit check output and SAS data listings.•Filed study-specific documentation.•Conducted database build UAT.•Trained new hires and support staff on data management processes.

• Designed CRFs and related Case Report Form Completion Guidelines (CCGs).• Developed DMPs (Data Management Plans) and other procedural documents to identify data flow through database lock.• Reviewed and validated clinical data using programed EDC checks, SAS listings, and manual review.• Performed MedDRA and WhoDrug dictionary coding.• Coordinated SAE/AE reconciliation.• Created patient and study metric reports.• Performed user acceptance testing.• Performed clinical laboratory and other external data reconciliation.

• Served as Lead Data Manager or supported the Lead Data Manager in all phases of clinical data management from study start up activities to database lock.• Implemented structured UAT for the database opens and migrations, coordinating testing efforts with 8-10 team members.• Conducted a systematic approach to validate clinical data, integrating programmed EDC checks, SAS listings and detailed manual reviews.• Collaborated in migrating data from a legacy rescue study to a new EDC database meeting aggressive timelines.• Performed local lab reconciliation.

• Managed data collection and cleaning for complex Phase I, II, and III clinical trials.• Conducted thorough reviews and revisions of existing workflow documents and SOPs ensuring alignment with best practices.• Developed Data Management Plans (DMPs), edit check documents, data entry guidelines and data conventions.

• Mentored a project team of 8 professionals.• Coordinated closely with the sponsor, project manager, statisticians, and database developer to streamline database management processes and deliver reliable data within budget.• Managed the clinical data management process for multiple clinical trials, ensuring data accuracy and timeliness.• Reviewed study data, issued queries, reviewed site responses per specifications in edit check document.• Designed Case Report Forms (CRFs) and developed CRF completion guidelines (CCGs).

Carlsbad, California, United States

Bachelor Of Science - Bs, Biology, General

Bachelor Of Arts - Ba, English Language And Literature, General