Over 15 years clinical study management experience working in highly matrixed and dynamic environments which include Pharma and Clinical Research Organizations. Strengths include: writing, flexibility, proficient analytic, study management, interpersonal and communication skills, attention to detail, ability to multi-task efficiently, manage ambiguity, lead multi-disciplinary teams, a self-starter and sets priorities to meet aggressive timelines. Therapeutic areas include: CNS, infectious disease, vaccines, oncology (renal cell carcinoma, breast cancer, hepatocellular carcinoma & metastatic colorectal cancer), Cystic Fibrosis and metabolic disease (diabetes). Have managed PI-PIII studies to include study start up, study maintenance and study close out.
A highly experienced Senior Clinical Study Manager, Project Management and Leader of TMF with 8 years around the world experience within the CRO, Pharmaceutical environment and Clinical Packaging. Key experiences are within HAL human abuse liability studies, Oncology, Psychiatry/Psychology, Obstetrics/Gynecology and Neurology therapeutic areas. Lead trainer in processes for set up, maintenance, and support for assigned clinical projects. Monitor TMF throughout the study duration, identify and record quality problems, suggest, initiate, recommend or provide solutions as appropriate. Report TMF metrics trending and analysis as appropriate with resolution plans to proactively identify & avoid future issues Prepare/present TMF related information at internal meetings in a globally consistent format. Leader trainer for onboarding new project management. Maintained the TMF for all clinical trials assigned. Act as single point of contact for the client and facilitate responses to Customer questions and observations.