Silva Stoughton MS, CCDM

Performed a realm of Data Management roles including DM oversight for CROs and study lead data manager. Responsible for all data management activities from study start up through database lock, such as CRF specifications, develop edit check specifications, create CRF completion guidelines, author data management plans, test and QC all aspects of database, external vendor data transfer agreements, lab reconciliation, perform and manage data review for data cleaning, lead data review meetings, database lock, eTMF filing, and final study archival. Execution of timely and accurate data deliverables, committed to excellence and study success.

Design and perform in vivo models in support of early phase drug discovery. Therapeutic areas of study: oncology, rheumatoid arthritis, hind limb edema, ocular, pulmonary, cardiovascular, asthma, toxicology, and pharmacokinetic studies.