Over 15 years as a multi-talented Clinical Research Professional managing Phase II-IV clinical trials in different therapeutic areas. Responsible for comprehensive project development and management. Experience also includes compliance according to ICH/GCPs and other regulatory agency guidelines. As well as dedicated experience in complying with study protocols, standard operating procedures. Practiced problem-solver with strong attention to detail. Proficient in handling patient information, laboratory samples, and compliance procedures for different clinical trials. Well-organized and hardworking with excellent communication and planning skills. Prepared to offer extensive experience in the field and take on a fast-paced position.
Vaccines, GI (Crohn's Disease, Ulcerative Colitis, IBS-D, IBS-C, GERD, Lactose Intolerance), Cardiovascular (Cholesterol, AFIB, HRVD), Neurology (Migraine, Parkinson's Disease), Respiratory (Asthma, COPD),
Other (Osteoarthritis, Rheumatoid Arthritis, Overactive Bladder, Insomnia), Endocrinology (Diabetes, Diabetic Neuropathy), Nephrology (CKD, Metabolic Acidosis, Dialysis).
• A 66-Week Extension to A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control
• A Phase IIb Randomized, Placebo and Active Comparator (Tolterodine) Controlled, 2-Part Clinical Study of the Efficacy and Safety of MK-4618 in Patients with Overactive Bladder
• A Phase II Randomized, Placebo-controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adults with Autoimmune Disease
• A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Assess the Efficacy and Safety of Budesonide Foam (2MG/25ML BID for 2 Weeks, Followed by 2MG/25ML QD for 4 Weeks) Versus Placebo in Subjects with Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
• A Phase III Randomized, Double-blind, Placebo-controlled Multi-center Study of Subcutaneous Secukinumab in Pre-filled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long-Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNF Agents
• A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects with Metabolic Acidosis
• DM199-2019-001, “A Multi-Center Open-label Investigation to Assess the Safety and Efficacy of Multiple Doses of DM199 in Patients with Chronic Kidney Disease (Stage II or III)”
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