Syneos Health (Previously INC Research/inVentiv Health)Clinical Lead/Senior Clinical Research Associate II
Mar. 2014 - Mar. 2021Ortigas, Philippines
Site Management: Multicenter, International and local clinical trials, phase II, III, and IV
Experience in conducting pre-study, initation, interim and close out, good knowledge of ICH-GCP CRA Management: Observational and mentoring of new company/junior CRAs, feedback for annual appraisal assessments Project Management: Oversight of APAC and European CRA team; focus on metrics, budget and time usage and allocations, reporting to project leadership, trip report review, forecasting, audit support and CAPA management, local and virtual CRA meetings, support and or creation of plans and documents needed for operational conduct of clinical trials, collaboration with various departments (Site ID and Site Start-up, Data Management, Medical Monitor, Statistics, Pharmacovigilance, etc.) for the successful delivery execution of the project. Therapeutic Area of Experience:
Autoimmunity and Inflammatory: Knee and Hip Osteoarthritis, Rheumatoid Arthritis
CNS Neurology: Parkinson's Disease
CNS Psychiatry: Major Depression, Schizophrenia
Cardiovascular and Metabolic: Pulmonary Hypertension (Pediatric and Adults)
Dermatology: Psoriasis, Atopic Dermatitis
Endocrinology: Type 2 Diabetes Mellitus
Infectious Disease: Tuberculosis Infection (Multi-Drug Resistant), Complicated Urinary Tract Infection, Gram Negative Infections, HAP/VAP/HCABP
Oncology: Cancer, Breast, Cancer, Lung Non-Small Cell, Cancer, Lung HCC
Vaccines: Gynecological Cancer, Diphtheria/Tetanus/Pertussis, 5 in 1, Inactivated Poliovirus, Pneumococcal Conjugate Vaccine, Respiratory Syncytial Virus (pediatric and maternal)
Nutrition/Metabolism: Infants Nutrition