Monique Vandersteur

Background

About Monique Vandersteur

Versatile clinical research professional with over 18 years of experience in domestic and international clinical research Solid foundation in FDA Regulations, GCP and ICH Guidelines, IRB requirements and company SOPsClinical program lead, risk and project management experience with timeline, budgetary, marketing companies/CRO and other vendor managementLead and implement globally agreed study delivery and clinical development strategies including process and technology related to study deliverablesGlobal clinical trial experience- Phase I-IV:Neuroscience (Bipolar Disorder, Schizophrenia, Major Depression Disorder, Generalized Anxiety Disorder, Borderline Personality Disorder, Alzheimer’s Disease)Pediatric MigraineVaccines (Flu & Meningitis)Ophthalmology (cataract and optic neuropathy) Infection RA and OAGeneral (weigh loss) Medical devices (Neonatal products)Indirect management of Study Delivery Leaders assigned to project teams, including resource gap identification, performance matters, and training/mentoring Review of scientific literature and development of study design and protocol, operational feasibility, development of recruitment strategiesProject management skills with effective troubleshooting and problem solving skills in high- pressure situations. Inventive, analytical and resourceful to accomplish goals within established timelinesSpecialties: Global project and clinical study managementClinical data management activities including experience in Web Based Data, SAS datasets, CRF design, data review, and QC, query resolution, and SAE reconciliation, eSourceAbility to assimilate complex protocols and monitoring plans quicklyGood diagnostic skills and treatment planning and execution proficiency