Ms. Bridges has more than 14 years’ experience in drug development. She is experienced in clinical trial operations, clinical trial monitoring, project management, and project coordination. Ms. Bridges’s monitoring experience includes Phase 3 recurrent herpes labialis, Phase 3 chronic low back pain, Phase 3 CIAS1 associated periodic syndromes, Phase 2 advanced neuroendocrine tumors, Phase 1/2a acute thoracic and cervical spinal cord injury, and Phase 1 gene therapy for Parkinson’s disease. Ms. Bridges’s management experience includes Phase 1 through Phase 3 oncology studies, including breast cancer, prostate cancer, non small-cell lung cancer, and multiple myeloma, Phase 3 hematology, Phase 1 gene therapy for Parkinson’s disease, Phase I Intranasal Granisetron and Phase 2 Tourette's Syndrome. In addition, Ms. Bridges has received training and continuing education in drug development, project management, data management, Food and Drug Administration and International Conference on Harmonisation regulations and guidelines, and regulatory compliance. She is certified as a clinical research associate by the Association of Clinical Research Professionals.

Clinical Team Lead @ Typically serves as the Lead CRA with full responsibilities for clinical monitoring and line management of CRAs. Ensures appropriate communication, regulatory documentation, and ongoing oversight. From April 2013 to Present (2 years 9 months) Clinical Research Manager @ My responsibilities include… From June 2012 to March 2013 (10 months) Clinical Research Associate/Study Manager @ Oversees clinical operational project activities in conjunction with project manager. Serves as project liason for clinical sites and monitors. Responsible for managing the direction, planning and execution of clinical trials and data collection activities including recruitment and enrollment strategies, oversight of monitoring activities, study conduct, compliance with regulatory standards and completion of data transfer. Assists with interpretation of clinical data. Authors study-related deliverables including study procedures manuals and monitoring plans. Conducts investigational site selection, initiation, periodic, and termination visits. Serves as liaison between the sponsor and the investigator, serves as a resource for investigational site queries, reviews investigator contracts, and participates in project team meetings and sponsor telephone conference calls on a regular basis. Travels to investigational sites to verify the following: that the rights and well-being of human subjects are protected; that the reported trial data are complete, accurate, and verifiable per source documents; and that the trial is conducted in compliance with the currently approved protocol, Good Clinical Practice, International Conference on Harmonisation E6 guidelines, standard operating procedures, and applicable regulations. Other responsibilities include verifying proper storage conditions, accountability, and disposition of the investigational products; maintenance of up-to-date and accurate investigator study files; and accurate recording and reporting of adverse experiences. Writes and submits written reports of investigation site findings. From February 2005 to June 2012 (7 years 5 months) Project Coordinator @ As a project manager, responsibilities included coordinating and managing activities listed under senior project coordinator, while continuing to function as clinical trial manager. Also was involved in coordinating and managing multidisciplinary project teams. Took part in comonitoring visits of managed projects with assigned project monitors. Also participated in initiation visits with assigned site monitors. As a clinical trial manager, was responsible for managing the direction, planning, and execution of clinical trials and data collection activities, and for assisting with the interpretation of clinical data. Provided input into design and implementation of clinical protocols, data collection systems, and final reports. Responsibilities for study execution included recruitment and enrollment strategies, oversight of monitoring activities, study conduct, compliance with regulatory standards, and completion of data transfer. Prepared for and participated in audits. Prepared study-related documents and reports of trial progress. Developed and administered budgets and contracts. Interacted with various internal and external groups to facilitate conduct of clinical trials. As a senior project coordinator, responsibilities included overseeing monitoring activities, study conduct compliance with regulatory standards, and data collection activities. Interacted with various internal and external groups to facilitate conduct of clinical trials. Was responsible for preparation of study-related documents and reports of trial progress, and development and administration budgets and contracts. From February 2000 to February 2004 (4 years 1 month)

M.A., Agricultural Extension Education @ North Carolina State University From 2002 to 2004 B.S., Animal Science @ Clemson University From 1995 to 1999 Martha Bridges is skilled in: Clinical Trials, CRO, CTMS, Clinical Monitoring, GCP, Oncology, EDC, Clinical Development, Clinical Research, Pharmaceutical Industry, Regulatory Affairs, Drug Development, FDA, Clinical Study Design, ICH-GCP