Mia Muchnick
Exton,PA
Summary
Experienced Clinical Business Operations Analyst with a strong background in clinical trial research. Recognizes and addresses process inefficiencies, excels at implementing strategic solutions to optimize operational performance. Expertise lies in leveraging data analysis and project management skills to drive continuous improvement and contribute to organizational objectives.
Overview
4
4
years of professional experience
Work History
Business Operations Analyst
Kyowa Kirin
07.2024 - Current
- Accurately enter clinical trial data into Sponsor Operations systems or other designated databases in a timely manner (e.g. Planisware)
- Perform analysis of clinical trial data, including generating reports, summaries, and graphical representations as required.
- Perform quality control checks on entered data to detect discrepancies.
- Enhance operational efficiency by executing process improvements.
- Facilitated change management processes during times of organizational restructuring or transformation efforts.
Senior Clinical Trial Assistant
Marinus Pharmaceuticals
04.2023 - 06.2024
- Supports the clinical study team members with accurately updating and maintaining the clinical trial management system (CTMS), archiving trial data, and documents.
- Assists in budget preparation by analyzing resource requirements while maintaining cost efficiency.
- Supervision of all study parameters, including clinical study startup activities, supplies preparation, enrollment, data collection, and close out.
- Oversees management and reconciliation of the Trial Master File (TMF) for inspection readiness including proficiency in QC review and issue resolution.
- Responsible for creation, maintenance, and distribution of study-level reports, meeting agenda and minutes, and excel trackers for clinical management usage.
- Manages and provides oversight of CRO and third-party vendors to ensure quality and adherence to ICH/GCP standards as well as established timelines.
- Facilitates in managing and developing study-specific materials, such as informed consent forms, study plans, and subject recruitment materials, to ensure data integrity and regulatory compliance.
- Conducts regular quarterly audits of three study trial master files to ensure completeness, accuracy, and compliance with regulations.
- Participates in the selection of appropriate clinical sites by evaluating potential locations and assessing capacity for successful trial outcomes.
Senior Global Clinical Trial Assistant
ICON
11.2021 - 04.2023
- Supported operational aspects of all GCO managed trials, both internally managed and outsourced trials, with variation across all phases of a trial (planning, start-up, execution, data analysis, report and closure).
- Worked in support of the trial team, including the GCO Program Leader, GCO Trial Leader, and Clinical Trial manager.
- Services provided included tracker trial progress towards planned milestones, as well as related progress analysis and follow-up.
- Tracked the trial and country budgets and supported invoice reconciliation.
- Supported protocol and country feasibility, site selection, and vendor set-up.
- Performed trial specific system set-up and access management, system data entry and was responsible for internal external meeting planning, coordination, outcome documentation, and related follow-up.
- Oversaw electronic TMF document management and quality.
- Contributed to clinical trial execution by coordinating with cross-functional teams and ensuring regulatory compliance.
Clinical Project Assistant I
Clinlogix, LLC
02.2021 - 11.2021
- Assisted with updating and maintaining study relevant documents.
- Supported clinical sites with designated project communications, correspondence, and associated documentation.
- Collaborated with Project Managers, CRAs, and Sponsors with development, preparation, handling and distribution of Study Supplies (ie. relevant study binders and packets) and manage distribution status per study.
- Set up study files and maintain records in the Clinical Trial Management Systems (TMF, CTMs, etc.)
- Distributed, requested, collected, and reviewed site regulatory documents for the applicable phase of the study (Start Up, Enrollment, Follow-up, Maintenance, etc.)
- Aided study team on ensuring sites' compliance to study protocol, timeline and regulatory guidelines.
- Created and completed informed consent form (ICF) checklists for applicable sites and studies as needed.
- Maintained and tracked all study personnel's up-to-date training status and information.
- Facilitated collection and review of safety source documents provided by sites.
- Supported sites & study team with study related documents/imaging uploads.
Education
Bachelor of Arts - Global Studies
Temple University
12.2019
Skills
CRO Oversight
In-House and Outsourced Studies Management
Proficient in Small Team Management
Early and Late Phase Trials
Central and Local IRB Submissions
Experienced in Rescue Studies/Portfolio Acquisitions
Has taken part in External Audits/Audit Query Responses
In-office and Online TMF Reconciliation
Inspection Readiness
Vendor Supply Management
Standard Operational Procedure (SOP) Creation
Training Plan Creation
Electronic Data Capture
System Proficiencies
• Veeva Vault/Veeva CTMS
• Intrinsic Study Management Tool
• SimpleTrials
• LabCorp LabLink+ and Xcellerate
• WordPress
• Medidata RAVE
•Signant Health Randomization and
Trial Supply
• Planisware
• IBM eCOS
• Zelta EDC
• Microsoft Suite
• BOX Collaboration
• Cysco Jabber
• Zoom
• Webex
Timeline
Business Operations Analyst
Kyowa Kirin
07.2024 - Current
Senior Clinical Trial Assistant
Marinus Pharmaceuticals
04.2023 - 06.2024
Senior Global Clinical Trial Assistant
ICON
11.2021 - 04.2023
Clinical Project Assistant I
Clinlogix, LLC
02.2021 - 11.2021
Bachelor of Arts - Global Studies
Temple University
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