A highly motivated, detail-oriented, and results-driven professional with over 15 years of experience in the pharmaceutical industry. Strong background in the areas of pharmacy and medical device industries.
SKILLS
audits, assessment, evaluations, responsible, drug safety, safety, fda, writing
Assisted in the development and implementation of the FDA and other regulatory documentation for the research studies. Provided training and mentoring to junior CRAs.
Provide training and supervision for all aspects of the safety assessment and the preparation of the final report for the FDA.
Manage the development and monitoring of annual and annual performance evaluations, including the development of new hire training programs, and the planning of the program.
Assists in writing and reviewing of internal audits and annual reports for the FDA. Reviews and approve all regulatory documents.
Responsible for the development and execution of the company's policies and procedures. Support the development of the project and the business plan.
Provides technical support to the development and commercialization of new products and processes. Develop and implement the product and process improvement strategy.
2017-12-252017-12-25
Clinical Project Manager
Career Connect Live
Member of the project management team responsible for the development and execution of the budget and operational plans. Developed and implemented a new study for the company.
Worked with cardiovascular, Neurology, oncology, and pediatric trials to develop and implement strategies for the development of new protocols and procedures.
Supported the development of therapeutic and medical Affairs for the EU affiliates. Developed and implemented a new study for the Bayer global Oncology group.
Reviewed and verified data for Phase III trials in infectious disease and infectious disease. Conducted site visits for sites.
Reviewed and approved study specific documents for completeness and accuracy. Developed and implemented corrective action plans. Identified and resolved issues.
Reviewed and approved study specific documents for completeness and accuracy. Developed and implemented corrective action plans. Ensured that all study deliverables are met.