Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
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Marta Smoleń

Warsaw,Mazowieckie

Summary

Experienced Clinical Project Manager with a background in biotechnology and a proven track record in leading multi-site trials across hematology, neurology, and oncology. Successfully managed six trials enrolling over 4000 patients, improving TMF compliance from 10% to 90%. Skilled in vendor oversight, GCP compliance, cross-functional team leadership, and process optimization. Proficient in data analysis and reporting using Excel and Power Query. Strong experience in audit preparation, consistently achieving positive outcomes and inspection readiness. Results-driven, detail-oriented, and focused on timely, high-quality project delivery.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Clinical Trial Manager

Fortrea
11.2024 - Current
  • Patient Recruitment & Enrollment Strategy: Led the implementation of targeted enrollment tools in response to a screening stop, resulting in the randomization of 150+ additional patients and meeting critical enrollment deadlines within 8 weeks.
  • Clinical Operations Optimization & Compliance
    Optimized clinical operations by implementing a TMF management tool, resulting in over 90% improvement in document compliance and significantly increased trial efficiency.
  • Trial Startup & Execution Acceleration: Streamlined trial startup and execution processes, resulting in a 20% decrease in trial initiation timelines.
  • Cross-Functional Team Leadership & Project Delivery: Collaborated with cross-functional teams to ensure transparency and adherence to project timelines, improving on-time project completion by 10%.
  • Risk Management & Operational Oversight: Drove comprehensive risk management initiatives, reducing aging risks by 30%.

Vendor Manager

Fortrea
08.2024 - 11.2024
  • Vendor Selection & Contracting across 6 studies: Lead vendor identification, Request for Proposal (RFP) processes, and contract negotiations in collaboration with procurement and legal teams, conducted quaterly reviews to assess performance against contracts and identify improvement areas.
  • Performance Oversight: Track vendor KPIs to ensure quality and timeliness of deliverables.
  • Relationship Management: Serve as the main liaison between internal teams and vendors, ensuring strong collaboration and clear communication.
  • Budget Control: Monitor vendor-related budgets, forecasts, and change orders to ensure cost-effectiveness.

Project Coordinator

Covance / Labcorp
02.2021 - 08.2024
  • Notable Contribution: Designed and implemented a custom unblinding tool, enabling the timely release of over 2000 patient data sets to clinical sites—ensuring compliance and delivery despite complex trial challenges.
  • Project Documentation & Oversight: Managed and maintained TMF systems with a strong focus on documentation quality, compliance, and audit readiness. Created and optimized study trackers to support real-time monitoring and reporting.
  • Meeting & Stakeholder Coordination: Organized and facilitated cross-functional meetings, including agenda preparation, minute-taking, and action item follow-up using Xcellerate.
  • Site & Vendor Management: Acted as primary liaison between investigative sites and vendors to ensure timely collection of essential documents and operational updates.
  • Regulatory & Study Start-Up Support: Supported preparation, tracking, and submission of ethics and regulatory documentation during start-up phases, ensuring alignment with global and local requirements.
  • Data & Systems Oversight: Maintained high-quality data entry and compliance across CTMS, EDC, and IRT platforms, ensuring data integrity and system accuracy.
  • Milestone & Budget Tracking: Monitored project timelines, deliverables, and budgets; escalated out-of-scope activities and financial risks using Veeva UCV, CTMS, and Microsoft Project.

Laboratory Assistant

Health Station
06.2020 - 01.2021
  • Conducted laboratory experiments using advanced techniques, including PCR and microbiological analysis, performing more than 10 000 tests per month.
  • Maintained and calibrated laboratory equipment to ensure accuracy and reliability of results.
  • Collected and analyzed data, contributing to academic research and project reports. Ensured compliance with laboratory safety protocols and best practices
  • Served as a reliable source of information for colleagues seeking assistance or clarification on laboratory procedures or equipment use.
  • Managed inventory levels effectively by tracking supply usage and placing orders for required materials before depletion.

Education

Master of Science - Biotechnology

University of Life Sciences
Lublin, Poland
07-2020

Skills

  • Risk and budget management
  • GCP Knowledge
  • Regulatory compliance
  • Customer Focus
  • Problem resolution
  • Training and mentoring and program development
  • Time management
  • Stakeholder Communication
  • Team leadership
  • Teamwork and collaboration
  • Microsoft Office (Excel, PowerPoint, Project, Word)

Certification

  • Microsoft Project: Step-by-Step Planning for Successful
  • Project Management, LinkedIn, 2024
  • Six Sigma Green Belt, LinkedIn, 2024
  • Agile Foundations, LinkedIn, 2023
  • Project Management Foundations: Requirements, LinkedIn, 2023
  • Scrum Foundations, LinkedIn, 2023
  • Professional Management PMP, Udemy, 2022

Languages

Polish
Bilingual or Proficient (C2)
English
Advanced (C1)
Spanish
Upper intermediate (B2)

Timeline

Clinical Trial Manager

Fortrea
11.2024 - Current

Vendor Manager

Fortrea
08.2024 - 11.2024

Project Coordinator

Covance / Labcorp
02.2021 - 08.2024

Laboratory Assistant

Health Station
06.2020 - 01.2021

Master of Science - Biotechnology

University of Life Sciences

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Marta Smoleń