KATHRYN Arias
Durham,NC
Summary
Expert in biospecimen lifecycle management, overseeing global clinical trial operations to ensure regulatory compliance and data integrity. Strong background in developing sample management plans and optimizing workflows, enhancing efficiency across study sites. Proven ability to resolve complex issues and mitigate operational risks.
Overview
1
1
Certification
15
15
years of professional experience
Work History
Sr. Manager, Clinical Sample and Biomarker Operations
SpringWorks Therapeutics
Durham, NC
08.2025 - 09.2026
- Led end-to-end biospecimen lifecycle strategy across Phase I-IV clinical trials, designing sample collection and logistics plans that align scientific objectives with site feasibility and clinical execution.
- Partner cross-functionally with Clinical Pharmacology, Clinical Operations, Translational Sciences, Data Management, CRO’s, sites and central/analytical labs to ensure seamless sample execution from collection through analysis and post-study use, consistently delivering complete datasets without sample gaps.
- Oversaw CROs, central labs, bioanalytical and biomarker vendors, and managing performance, and issue escalation to ensure timely delivery of high-quality samples and data.
- Serve as biospecimen SME, proactively managing sample logistics, resolving data discrepancies and anticipating downstream analytical and post-study needs to enable on-time sample analysis while preventing avoidable protocol and study document amendments.
- Author and review lab manuals, sample management plans, SOPs, ensuring protocol alignment, GCP compliance, and data integrity across studies.
- Built and maintained Excel-based tracking systems for biospecimen inventory, query tracking, shipment, and third-party data reconciliation across 13 clinical trials, enhancing visibility and management of sample logistics.
- Monitored sample-related activities to ensure adherence to GCP regulations.
- Managed sample-related deviations, missed shipments, temperature excursions, and stability events, leading root cause analysis and CAPA implementation to ensure protocol compliance and readiness for inspections.
Sample Operations Manager
SpringWorks Therapeutics
Durham, NC
04.2022 - 08.2025
- Led biomarker and biospecimen operations across clinical programs, ensuring execution aligned with translational strategy and clinical development goals.
- Managed CROs and bioanalytical vendors for sample assays, ensuring compliance with timelines, quality standards, and study requirements.
- Developed and implemented sample handling workflows and training to enhance consistency and quality across study sites.
- Collaborated cross-functionally to align biomarker strategy with clinical operations and protocol design, facilitating effective study execution.
- Supported GCP-compliant trial execution, including site engagement and source data verification.
Specimen Management Operations Manager
LabCorp Drug Development
Durham, NC
10.2021 - 04.2022
- Executed global sample management strategies, ensuring adherence to timelines, quality standards, and client expectations across multiple labs.
- Led global clinical trial specimen management operations, supporting high-volume sample processing, tracking, and resolution across multiple studies.
- Oversaw issue resolution workflows, partnering with project managers, labs, and clients to resolve complex sample discrepancies.
- Implemented quality control strategies to safeguard business assets and enhance quality, achieving an 85% reduction in quality errors.
- Tracked employee performance to identify strengths and enhance team effectiveness through targeted direction and support.
- Led business expansion in Los Angeles, overseeing new construction and building retrofits to support organizational growth.
Specimen Management Operations Supervisor
LabCorp Drug Development
Durham, NC
09.2016 - 10.2021
- Directed clinical trials specimen management team at Center for Molecular Biology and Pathology.
- Trained new staff on standard operating procedures and safety protocols.
- Implemented process improvements to enhance operational efficiency.
- Conducted performance evaluations and provided constructive feedback to team members.
- Led specimen management department coordination of global sample management strategy, process design, structures, and metrics to strengthen operational performance.
- Advanced through progressive leadership roles in specimen management operations during inaugural leadership and development program from Sep 2016 to Mar 2020 in Indianapolis, IN, supporting team growth and operational success.
Pharmacy Technician Level 3
Meijer
Champaign, IL
10.2014 - 09.2015
- Processed prescriptions and insurance claims, ensuring accurate dispensing, labeling, and inventory control to support pharmacy operations.
- Provided customer service and counseling support, resolving prescription and billing issues to enhance patient satisfaction.
- Maintained accurate records and managed cash handling, ensuring compliance with storage and expiration requirements to uphold safety standards.
Personal Assistant
Enlyt Media
Boise, ID
01.2014 - 06.2014
- Coordinated complex calendars to enhance time management and optimize executive availability for meetings., meetings, travel, and personal/business commitments.
- Provided administrative and operational support to managers and directors by efficiently managing scheduling, correspondence, and document organization.
- Handled email correspondence, streamlining communication processes and enhancing responsiveness for both personal and business matters., mail, and text communications for personal and business purposes, enhancing overall communication flow.
- Functioned as a liaison between clients and leadership, promoting clear communication and follow-through.
- Supported special projects through comprehensive research, information synthesis, and drafting concise summaries to facilitate decision-making.
- Designed a course catalog for a newly established college initiative.
Recruiting Assistant
University of Illinois Football
Champaign, IL
09.2011 - 12.2013
- Acted as liaison between football recruits and coaching staff, facilitating clear communication and coordination.
- Hosted recruits during official visits, game days, and tours.
- Supported students, recruits, coaches, and staff at front desk, efficiently managing daily requests and inquiries.
- Handled phone calls, emails, mailings, and calendars independently to ensure smooth communication.
- Maintained accurate databases, filing systems, and office inventory.
- Controlled access to coaches and staff, maintaining a quiet work environment to minimize disruptions.
Education
Bachelor of Science - Integrative Biology
University of Illinois
Urbana-Champaign08-2016
Skills
- Biospecimen lifecycle management
- Bioanalytical PK/PD and biomarker management
- Quality assurance and regulatory compliance
- Root cause analysis and CAPA implementation
- Strategic planning
- Attention to detail
- Lab manuals and sample plans
- Data reconciliation with Excel and Power BI
- Software proficiency
- Process optimization and risk mitigation
- Cross-functional leadership
- Team development and mentorship
- Global clinical trials (Phase I-IV)
- Vendor and budget oversight
Certification
- CITI Clinical Research Coordinator 2025
- CITI Clinical Research Associate 2025
Affiliations
- THRIVE ERG - Leader
An employee resource group that aspires to create a sustainable workplace culture, integrates work-life flexibility and ensures energy, vitality, resilience, and balance of its members. - HBA (Healthcare Businesswoman Association) - Member and Volunteer
- WIB (Women in Bio) - Member
- TriWiSTEM (Triangle Women in STEM) - Member and Volunteer
- OneWe Reach - Member
- Nord Family Foundation - Volunteer
- Biospecimen Industry Collaboration (BIC) - Past member
Timeline
Sr. Manager, Clinical Sample and Biomarker Operations
SpringWorks Therapeutics
08.2025 - 09.2026
Sample Operations Manager
SpringWorks Therapeutics
04.2022 - 08.2025
Specimen Management Operations Manager
LabCorp Drug Development
10.2021 - 04.2022
Specimen Management Operations Supervisor
LabCorp Drug Development
09.2016 - 10.2021
Pharmacy Technician Level 3
Meijer
10.2014 - 09.2015
Personal Assistant
Enlyt Media
01.2014 - 06.2014
Recruiting Assistant
University of Illinois Football
09.2011 - 12.2013
Bachelor of Science - Integrative Biology
University of Illinois