SAMUEL BUDNIK
Jackson,WI
Summary
Clinical research professional with 8+ years of experience within Phase I trials and progressive leadership within Spaulding Clinical Research. Demonstrated success overseeing study operations, managing team workload, mentoring staff, and driving process improvements. Strong expertise in ICH-GCP, FDA regulations, SOP development, CAPA investigations, and sponsor collaboration. Recognized for improving operational efficiency, ensuring compliance, and leading teams to successful study execution.
Overview
11
11
years of professional experience
Work History
Study Manager
Spaulding Clinical
West Bend, USA
07.2024 - Current
- Provide operational oversight and guidance to Associate Study Managers, Screening Coordinators, and clinical staff to ensure protocol adherence and execution.
- Planned and coordinated Phase 1 study startup, tracking protocol compliance and sustaining audit-readiness.
- Manage and distribute workload across study team members to optimize efficiency and meet study timelines.
- Acted as primary escalation point for clinical execution issues, resolving problems swiftly to minimize disruptions to study timelines.
- Implemented process improvements and trained 90+ clinical staff, enhancing trial execution and adherence to protocols.
- Provide protocol review and operational feedback to improve study feasibility and execution consistency.
- Draft and implement SOPs and Work Instructions (primarily spirometry procedures) to standardize operations.
- Developed customized EDC databases aligned with project specifications, reducing data entry errors and enhancing data organization.
- Manage vendor collaborations to ensure optimal performance and timely resource allocation.
- Participate in CAPA and COPE investigations, identifying root causes and implementing corrective/preventive actions.
- Serve as primary sponsor contact, leading clinical communications and ensuring alignment on deliverables and timelines.
- Maintained data integrity through regular quality audits and proactive issue resolution.
Associated Study Manager
Spaulding Clinical
West Bend, USA
10.2021 - 07.2024
- Managed comprehensive clinical trial operations for Phase 1 studies, ensuring compliance with ICH-GCP, FDA, and sponsor protocols to uphold study integrity.
- Directed cross-functional study teams (data management, safety, regulatory) to achieve trial milestones and resolve issues effectively.
- Monitored study metrics and delivered timely status updates to stakeholders, facilitating effective project tracking and proactive corrective action planning.
- Coordinated with vendors and CROs to ensure timely delivery of high-quality outputs within budget and contractual timelines, fostering productive partnerships.
- Prepared and maintained study documentation, including monitoring plans, risk assessments, and the TMF, ensuring audit-readiness and regulatory compliance.
Clinical Research Sample Specialist
Spaulding Clinical
West Bend, USA
02.2015 - 08.2018
- Supported clinical operations by executing precise and timely sample handling, facilitating seamless workflow.
- Operated centrifuges and prepared aliquots using validated procedures, ensuring reliable processing of high-volume biological samples.
- Maintained accurate documentation and chain-of-custody, enabling efficient audit readiness.
Education
Bachelor of Science - Biochemistry
University of Wisconsin - Madison
Madison05-2020
Skills
- Clinical Trial Oversight
- Good Clinical Practice
- Protocol Review
- Trial Master File
- Risk Management
- SOP Development
- Process Development
- Database Designing
- Data Organization
- Microsoft Office
- ClinSpark
- Supervision & Leadership
- Cross-functional Collaboration
- Client Relations
- Interpersonal skills
Accomplishments
Magis Award Nominee
Timeline
Study Manager
Spaulding Clinical
07.2024 - Current
Associated Study Manager
Spaulding Clinical
10.2021 - 07.2024
Clinical Research Sample Specialist
Spaulding Clinical
02.2015 - 08.2018
Bachelor of Science - Biochemistry
University of Wisconsin - Madison