Anna Jopek
Clinical Operations · Biotech · CRO

Anna Jopek

Global Study Associate at AstraZeneca, MSc Biotechnology. Coordinating cross-functional clinical trial delivery with a passion for TMF quality, inspection readiness and great science.

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About Me

I hold a Master's degree in Biotechnology from the Warsaw University of Technology. Since 2022 I have been part of AstraZeneca's clinical operations teams, supporting global studies across multiple therapeutic areas.

I started in Global Clinical Solutions, managing CTMS data and resolving operational tickets, before moving into Study Management roles within CVRM and then R&I. Each step deepened my expertise in clinical trial coordination, regulatory compliance (ICH-GCP / AZ SOPs), and cross-functional stakeholder management.

Since March 2024, as a GSA in SM R&I, I coordinate Phase 1–3 studies end-to-end - from start-up through close-out - partnering with CROs (Parexel, Alimentiv), vendors (LabCorp, Clario, Cytel), and global study teams to keep every trial on track, inspection-ready and well-documented.

Phone

514 584 194

LinkedIn

Anna Jopek

Location

Warsaw, Poland

Work Experience

Global Study Associate - Study Management R&I
Mar 2024 – Present
AstraZeneca · Warsaw

Supporting GSADs and GSMs with selected aspects of clinical trial management in Phase 1, 2 and 3 - internal and outsourced studies - across start-up, maintenance and close-out phases.

  • Maintenance of study eTMF; verifying quality of study documents
  • Initiated and maintained production of key study documents: TMF Plan, GSMOP, CTA Form, PRF, TORO, Inspection Readiness Checklist; led ICF updates
  • Administrative ownership: Study Training Log, distribution lists, shared mailboxes, system accesses; maintained Q&A Log, Decision, Issue and Risk Logs
  • Prepared and distributed project-related correspondence (agendas, meeting minutes, newsletters, presentations)
  • Direct Vendor Management: CISCRP (Thank You/Unblinding Cards), Cuttsy & Cuttsy (ICF summaries, HCP Referral Guide)
  • Vendor oversight in outsourced study: LabCorp, Clario, Cytel; collaboration with CROs Parexel and Alimentiv
  • PO creation/updates; review of contracts and invoices
Contractor - Study Management CVRM
Jun 2023 – Mar 2024
AstraZeneca · Warsaw

Supported the Global Study Team by completing delegated study work within the Cardiovascular, Renal & Metabolism therapeutic area.

  • eTMF management
  • Coordinating Training Matrix
  • Creating Investigator Newsletters
Contractor - Global Clinical Solutions
Aug 2022 – Mar 2024
AstraZeneca · Warsaw

Supported Global Directory and Outsourced Studies Teams with operational data quality and helpdesk activities.

  • CTMS data management: personnel & organisation management, activation/deactivation of records
  • Resolving tickets via AskGCS
  • Quality Checks of CTMS data

Education & Courses

Master of Science
Biotechnology
Warsaw University of Technology · Warsaw
Feb 2022 – Sep 2023
Engineer's Degree
Biotechnology
Warsaw University of Technology · Warsaw
Oct 2018 – Jan 2022

Professional Courses

Clinical Trials
Education for Business & Science
Basic Principles of Regulatory Affairs
Education for Business & Science

Skills & Languages

Core Skills
Organizational skills Time management Collaborative teamwork Problem solving Cross-functional coordination Stakeholder management
Clinical Operations
eTMF management ICH-GCP AZ SOPs CTMS Inspection readiness CRO oversight Vendor management Phase 1-3 trials ICF lifecycle Budget & PO management
Languages & Hobbies
Polish
Native
English
C1 Advanced
Spanish
A2 Elementary
💃 Dance
🎻 Violin
✈️ Travel

Get in Touch

I'm open to new opportunities in clinical operations, study management and regulatory affairs. Feel free to reach out via email or LinkedIn.

Open to Opportunities

Particularly interested in roles involving clinical trial coordination, study management and regulatory operations.

Clinical Operations Study Management Regulatory Affairs eTMF CRO Collaboration Phase 1–3