Trial Master Files Coordinator and Consulting October 2001 – PresentManager , Document Center – InClin Headquarters OfficeEstablished Clinical Document Center enabling expansion of client services and employee training. Development and initiation of processes and tracking tools for review, maintenance, and retention of sponsor files.Clinical Trials Experience: Trial Master Files Coordinator, Regulatory Associate, Clinical and Financial Document Administrator, Clinical Trial Assistant:• Phase-I: Antibiotics, Antifungal, Antiviral, Asthma, CF, Oncology• Phase I-II Monoclonal Antibodies in Asthma, CF, RA• Phase-II: Antibiotics, Antifungal, Antiviral, Chronic Cough, Osteoarthritis, Pain• Phase-III: Antibiotics, Antifungal, Antivirals, Chronic Cough, Immune Deficiency, Osteoarthritis, Osteoporosis, Vaccine(Hep-B)Syntex Corporation / Roche Global Development – Palo Alto, CAClinical Trial Assistant, Assistant to the Executive Administrator-Drug Development, Admin Assistant, CourierNovember 1991 through September 2001Specialties: Highest Degree of Client Confidentiality with a proven track record of success via multiple global marketing approvals with client's files maintained from EIM thru post-approval activities. Multiple studies handled as the Unblinded Clinical Doc Manager including unblinded aspect in support of Blinded Evaluation Committees and of course handling the blinded study team personnel with respect, tact, and diplomacy when saying "no, you can not see that file quite yet."
Listed skills include Clinical Trials, Clinical Development, Pharmaceutical Industry, and Oncology.
