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@magdalenadolegowska
Clinical operations leader driving compliant, high-quality clinical trial delivery.
PolandI am a clinical operations lead with extensive hands-on experience managing regional CRA teams and overseeing study deliverables to ensure compliance with ICH-GCP, local regulations and protocol requirements.
Across roles at Alimentiv, PPD/ThermoFisher, AstraZeneca and IQVIA, I have led site activation, monitoring, TMF oversight, vendor and sub‑CRO management, and operational start‑up and feasibility activities for therapeutic areas including oncology, cardiology, gastroenterology, hematology, nephrology, dermatology and women’s health.
I routinely develop training materials, present at sponsor kickoffs and investigator meetings, conduct CRA assessments and quality assurance visits, and implement recruitment/enrolment strategies to improve site performance and data quality.
I value mentorship and operational excellence, providing training and guidance to CRAs, supporting cross‑functional collaboration, and ensuring inspection readiness through proactive monitoring and corrective action implementation.
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Work history, roles, and key accomplishments
Alimentiv
Oct 2025 - Present (1 month)
Lead regional monitoring operations, oversight of CRAs and site management to ensure GCP compliance, timely site activation and recruitment, and delivery of study-level monitoring and TMF milestones.
PPD/ThermoFisher
Jul 2022 - Sep 2025 (3 years 2 months)
Managed regional CRA teams and sub-CRO oversight across EU and APAC, drove site and country performance improvements, and ensured delivery of monitoring, TMF and startup milestones.
PPD/ThermoFisher
Aug 2021 - Jun 2022 (10 months)
Led feasibility/site selection and regulatory submissions, developed global study tools, and managed remote and onsite site activities to ensure compliance and study readiness.
PPD/ThermoFisher
May 2018 - Jul 2021 (3 years 2 months)
Performed onsite and remote monitoring, QA visits, TMF maintenance and inspection readiness activities, resolving data queries and ensuring informed consent and GCP compliance at sites.
AstraZeneca
Aug 2017 - May 2018 (9 months)
Managed TMF accuracy, clinical site communications, clinical supply coordination and site training to maintain compliance and support study progress and inspections.
Quintiles/IQVIA
Feb 2016 - Aug 2017 (1 year 6 months)
Conducted monitoring visits, QA activities and inspection readiness, provided GCP training to sites, and managed site documentation and investigator payments.
Degrees, certifications, and relevant coursework
UWPost-Graduate Degree, Public Health and International Health
Post-graduate studies in Public Health and International Health completed in 2025.
SHPost-Graduate Degree, Clinical Sexology
Post-graduate studies in Clinical Sexology completed in 2017.
MWBachelor Degree, Midwifery
Bachelor degree in Midwifery completed in 2015.
SHMaster's Degree, Psychology
Master's degree in Psychology completed in 2015.
Software and tools used professionally
PolandYou can contact Magdalena and 90k+ other talented remote workers on Himalayas.
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