Associate Director Clinical Operations @ *Oversee a 6 person multidisciplinary team responsible for start-up and execution of clinical trial activities for multiple Phase I/II/III protocols across North America, Western Europe, and Australia
*Collaborate with clinical departments (e.g., regulatory, data management, clinical logistics, pre-clinical, medical writing, safety, and pharmacovigilance) to ensure achievement of corporate goals/timelines
*Manage fiscal responsibilities
Associate Director Clinical Operations @ *Oversee a 6 person multidisciplinary team responsible for start-up and execution of clinical trial activities for multiple Phase I/II/III protocols across North America, Western Europe, and Australia
*Collaborate with clinical departments (e.g., regulatory, data management, clinical logistics, pre-clinical, medical writing, safety, and pharmacovigilance) to ensure achievement of corporate goals/timelines
*Manage fiscal responsibilities including contracts and payments for all vendors under Clinical POs
*Enhance global visibility of the program through interactions with physicians and patient groups From February 2014 to Present (1 year 11 months) Clinical Trial Manager @ *Manage a 4 person team responsible for clinical trial activities for multiple Phase I/II/III protocols across North America, Western Europe, and Australia
*Prepare study status reports for executive management
*Provide input/support across clinical departments (e.g., regulatory, data management, clinical logistics, pre-clinical, medical writing, safety, and pharmacovigilance) to ensure achievement of program goals/timelines From October 2013 to February 2014 (5 months) Associate Clinical Project Manager @ *Oversee day-to-day clinical trial activities for multiple global Phase II/III projects
*Prepare and provide study status reports to senior management
*Provide support across clinical teams (e.g., regulatory, data management, clinical logistics, pre-clinical, medical writing, safety, and pharmacovigilance) to ensure needs are met throughout the life of the project From March 2013 to October 2013 (8 months) Senior Clinical Research Associate @ *Manage and monitor clinical trial activities for multiple projects
*Oversee the day-to-day activities of external CRAs
*Provide direction and training to vendors and CRAs to ensure compliance with study protocols, Company SOPs, ICH/GCP guidelines, and Federal Regulations From March 2012 to March 2013 (1 year 1 month) Clinical Research Associate I/II @ * Monitor clinical trials to ensure GCP compliance resulting in high quality, valid data which in turn supports the regulatory application and approval of new-marketed projects and indications
* Conduct research and outreach programs to identify and aid in the selection of new investigators
* Manage multi-center and multi-protocol trials From March 2008 to March 2012 (4 years 1 month) Senior Scientific Team Leader/Animal Logistics Coordinator @ *Oversee project progression and scheduling of >500 projects per year, in addition to, providing leadership and support for a 3 person team
*Initiate and maintain direct communication with clients and vendors to schedule all domestic and international mouse shipments to various institutions From May 2005 to March 2008 (2 years 11 months) Research Associate @ High throughput project management, accurate reporting and care of research animals in an independent work environment; tail biopsies; animal identification; intra-peritoneal injections; and coordination of project transfers. From January 2002 to May 2005 (3 years 5 months)
M.B.A, Human Resource Management @ University of Phoenix From 2002 to 2005 B.S., Biomedical Science @ Texas A&M University From 1998 to 2001 Associate Degree, Nursing @ Lone Star College Kingwood Shanna Jackson is skilled in: Clinical Trials, Biotechnology, Oncology, Type 2 Diabetes, Phase I, Phase 2, Rare Disease, Site Selection, Clinical Monitoring, Clinical Trial Management, Western Europe, Regulatory Requirements, Disease, Regulatory Affairs, Medical Writing
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