Unlimited Email and Phone number
Everything you need to reach more inboxes and close more deals
Unlimited Contact Only at$79
Stella Chróścicka
Monitoring Services Oversight Manager @Novartis Poland
Signup · Get unlimited contacts
WORK HISTORY
Monitoring Services Oversight Manager @Novartis Poland
PL
EDUCATION
Medical University, Gdańsk, Poland
PhD in Medical Science
University of Gdansk, Poland
Master of Business Administration
Akademia Medyczna w Gdansku
Master of Pharmacy
SKILLS
ABOUT STELLA CHRÓŚCICKA
A highly accomplished leader specializing in clinical trial documentation governance, oversight, and compliance. As a Senior Consultant, I provide expert guidance on inspection readiness, GxP documentation processes, and TMF best practices, ensuring operational excellence across clinical research functions. I have extensive experience as the Business Process Owner for Documentation Management, overseeing end-to-end TMF processes, documentation governance, and quality oversight. Leading international teams of Clinical Trial Documentation Managers and Specialists, I drive continuous improvement initiatives to enhance compliance, efficiency, and regulatory alignment. With deep expertise in GDP/GxP documentation processes, eTMF systems, and clinical trial data integrity, I collaborate with cross-functional teams, system administrators, and vendors to implement robust frameworks that optimize clinical documentation workflows. My strategic approach enables data-driven decision-making, leveraging trend analysis, staff engagement, and metrics-driven insights to enhance documentation management practices. Holding an advanced degree (PhD, MBA) and possessing a comprehensive understanding of clinical research, clinical medicine, and regulatory landscapes, I ensure that trial execution aligns with global regulations, SOPs, and corporate objectives. Areas of Expertise: Clinical Trial Documentation Governance Inspection Readiness & Regulatory Compliance TMF Quality Oversight & Process Optimization GxP Documentation & eTMF Systems Data-Driven Decision Making & Continuous Improvement Global Team Leadership & Stakeholder Engagement I am open to consulting opportunities and collaborations where my expertise can support organizations in strengthening their clinical documentation, compliance, and regulatory strategies. Let’s connect!
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.