EME Clinical Trial Management Pharmaceutical research professional with a high sense of ethics and over 17 years of experience in global clinical development, operations, and project management; team member of three successful new drug applications (NDAs) Highly skilled manager of US and global projects of pharmaceuticals, biologics, and devices Adept in design, implementation, and conduct of phase I – IV clinical trials, including investigator initiated trials Therapeutic experience in many adult and pediatric indications including solid tumor and leukemia oncology, attention deficit hyperactivity disorder (ADHD), epilepsy, fecal incontinence, orthostatic hypotension, diabetic ulcers, leishmaniasis, infectious disease and vaccines, infant formula growth velocity, and healthy normal volunteers Expertise in creating plans and writing documents for regulatory submissions, clinical study conduct, recruitment strategies, advertising materials, abstracts, and posters Strong skills in outsourcing management, strategic planning, and contract and budget negotiations Proficient in timeline management and overall study program budget forecasting and administration Skilled in the design of clinical trial material (CTM) packaging; and experienced in CTM inventory, control, accountability, and destruction; and well-informed of controlled substance regulations Excellent leadership and communication skills to support supervision and mentoring of staff, team members, and vendors Third year doctoral student with ongoing dissertation research on the topic of creating and maintaining trust in outsourcing relationships