Silviya Milovanski

Focused Clinical Research Manager well-versed in study protocols, standard operating procedures and general trial oversight. Excellent problem-solving abilities with a detail-oriented nature.

Skilled at collecting specimens, dispensing medications and consulting with patients during the course of clinical research trials.

Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

• Certified EMT

• ICH GCP E6 R2; FDA Regulations 21 CFR Parts 11, 50, 54, 56
• Principles of GDP in accordance with ALCOA-C
• Data Management and Electronic Data Capture (EDC)
• ICF process
• Identification and reporting of AEs and SAEs
• Quality assurance, Monitoring and Query Resolution
• Comprehension and execution of Clinical Trial Protocol
• Maintaining regulatory binder, housing essential documents such as: 1572, Source Documents, DOA, Training log, ECF, SAE forms, CRF, SOP, Site visit log, correspondences, Investigational Drug Brochure, Financial Disclosures, Subject enrolment log, and other investigational site file documents.
• Research skills such as collecting blood samples, vital signs, ECG, IV placement, proper documentation of trial procedures.

• Neuroscience : A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study, followed by an Open-Label Extension, to Determine the safety, Pharmacokinetics, and Pharmacodynamics of XXX in Participants with Amyotrophic Lateral Sclerosis.
• Neuroscience: A 52 Week, Multicenter, Phase 1 Open-Label Study to Evaluate the Safety of XXX in Participants with APOE4 Homozygote Alzheimer's Disease.
• Neuroscience: A Phase 1/2a Open-Label Ascending Dose Study to Evaluate the Safety and Effects of XXX in Patients with Parkinson's Disease with at Least One GBA1 Mutation.
• Neuroscience: A Phase 1/2 Ascending Dose Study to Evaluate the Safety and Effects on Progranulin Levels of XXX in Patients with Fronro-Temporal Dementia with Progranulin Mutations.
• Neuroscience: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of XXX in Healthy Volunteers and Patients with Alzheimer's Disease.
• A Phase one, Two-part, Double-Blind, Active-control, Randomized Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Repeated-Dose XXX Long-Acting Injection Following Subcutaneous ot Intramuscular Administration in Healthy Adult Participants.
• A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dose of XXX, a Monoclonal Antibody Targeting Respiratory Syncytial Virus, in Healthy Adults.
• A Phase 1, Randomized, Double-Blind, Placebo-Controlled, single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of XXX in Healthy Participants including Healthy Participants of Japanese Ethnicity and an Open-Label Assessments of Food Effects on the Relative Bioavailability of XXX.
• A Phase 1, First-in-human, Placebo-Controlled Study to Determine the Safety, Tolerability, and Pharmacokinetics of Orally Administered XXX in Healthy Young Adult and Middle-Aged Subjects and Elderly Subjects.
• A Phase 1 Study in Healthy Subjects to Evaluate the Relative Bioavailability of XXX Formulation in Pre-filled Syringe Manufactured by Two Different Processes.
• Assessment of Multiple-Dose Pharmacokinetics and Safety of the Co-Administration of XXX, XXX and XXX and Potential of XXX and XXX on CYP3A Induction in Healthy Volunteers.