Cheryl Gray Email and Phone Number

Oversee all Data Management activities performed by external EDC vendor from study start up to database archival. Review and approve all DM related study documentation and perform UAT of EDC database, IXRS and patient reported outcomes database. Participate in protocol review and approval as well as the final CSR review and approval as well. Manage the handling of all external lab data and the process for loading of data into Oracle Clinical Database.

Managed international organ transplant clinical trials and registries in iMedidata RAVE database and presented data analysis metrics prepared in multiple tables and graphs to Senior Management. Managed all external DM vendors, reviewed and approved all DM study related documentation and performed UAT and released the clinical database into production.

Manage external vendors, including CRO, Imaging Core Lab and Monitoring Center to ensure timelines and budgets are being met. Participate in Protocol design, developing CRF's, edit checks, DMP, Coding Plan, Data Transfer Specifications, Project Plan, Communication Plan, CEC Process Plan, UAT and Statistical Analysis Plan. Perform UAT on EDC/CEC database, which included safety reporting plan and guidelines that were developed based on country specific SAE reporting requirements. Develop monitoring schedule, review and approve monitoring reports, determine site payment schedules and approve invoices for site payments. Attend conferences, meetings with Investigators, Study Coordinators, CEC members and monitors to present study data and provide any database trainings. Contribute to Clinical Study Report and perform text to table validation with tables and listings being submitted with CSR.

Lead Clinical Data Manager on multiple medical device paper and EDC based studies, focusing on the development of DMP's, CRF Completion Guidelines, Audit Plans and the review and cleaning of clinical data. Also performed MeDRA coding, SAE reporting, generate safety narratives, and collaborate with Statistical group for DSMB updates and assist MM on SAE adjudication. Executed Operational Qualification testing for implementation of a new clinical trials EDC system to be utilized company wide.

Build and test Oracle Clinical database, develop training documentation, DE guidelines, DMP, ACRF's and manage DE team to ensure daily metrics are achieved.

Perform data review, query integration, SAE and Concomitant Medication Coding, SAE reconciliation, and review and develop Data Management study documentation.

Define QC process for all data transfers, review/resolve data output according to sas edit checks and track all metrics.

Perform data review and query integration across multiple EDC systems and Lead for Lab Reconciliation across multiple studies.

Perform Quality Control testing on Medical Device blood gas, coagulation and critical care instruments for both production distribution as well as field complaint investigations.

Cell processing specialist, assisting is surgical removal of fetal livers for the isolation and cryopreservation of hepatocytes.