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Iana Sedelnikova

@ianasedelnikova

Clinical Research Associate at Medpace supporting international Phase III trials, including close-out of a Duchenne Muscular Dystrophy study.

Russian Federation

Message

At Medpace, I support operational delivery of international Phase III studies in oncology and pediatric neurology through site management and clinical monitoring. I track study progress, protocol compliance, patient safety, data quality, and operational risks.

During a Phase III Duchenne Muscular Dystrophy study, I conducted Close-Out Visits, coordinating final data review, query resolution, investigational product return preparation, and archive readiness. I also maintain TMF and ISF documentation and record monitoring activities in CTMS (ClinTrak).

Previously, at X7 Research LLC, I supported a Phase IV Takeda hemato-oncology study as Assistant Project Manager during feasibility and start-up, coordinating communication with 50 investigative sites. At Vertex JSC, I supported sponsor-side study preparation and regulatory documentation, including CTD Modules 2 and 5.

Experience

Work history, roles, and key accomplishments

Current

Clinical Research Associate

Current

Medpace, Inc.

Dec 2021 - Present (4 years 10 months)

Supported operational delivery of international Phase III clinical studies in oncology and pediatric neurology, providing site management and clinical monitoring in accordance with ICH-GCP, study requirements, SOPs and applicable regulations. Collaborated with investigative sites and international cross-functional project teams to track study progress, maintain protocol compliance, patient safety,

Clinical Trial Management Site management Clinical Monitoring Risk Based Monitoring ICH GCP TMF ETMF ISF IWRS CTMS SDV Query Management CAPA Patient Safety Data Integrity Vendor coordination Cross functional Coordination team training

Clinical Research Associate

X7 Research LLC

Jun 2019 - Dec 2021 (2 years 6 months)

Supported and coordinated international Phase III–IV clinical trials and bioequivalence studies throughout the study lifecycle, working with investigative sites, Sponsors, CRO teams, vendors and cross-functional stakeholders. Experience included study management support, feasibility and start-up, site management and monitoring, recruitment tracking, clinical trial documentation, risk and issue man

Clinical Research Assistant

Vertex JSC

Jan 2018 - Jun 2019 (1 year 5 months)

Supported Sponsor-side clinical study preparation and study start-up activities, coordinating clinical and regulatory documentation, external vendors, study materials and timelines. Worked with internal teams, CROs and external partners to maintain study readiness and support timely progression of clinical and regulatory activities in accordance with ICH-GCP and applicable requirements.

Clinical Trial Documentation Regulatory Documentation Vendor coordination ICH GCP Pharmacovigilance ECTD Modules Study Start Up Project Coordination