20 years of Clinical Development experience with an expertise in Outsourcing best practices for all study phases with an understanding of the drug development process and the cross-functional responsibilities including trial design, start-up, maintenance, and close-out
•In-depth experience soliciting and evaluating CRO and service provider proposals, with highly successful SOW negotiations, along with growing long-term, strategic relationships with various clinical operations vendors
•Global therapeutic experience in Neurology, Oncology, Diabetes, Cardiology, Asthma, Sleep and Pain
•FDA and EMA inspection experience
•Strong data analysis and clinical financial reporting capabilities including post RFP analysis, accruals, and forecasting
•Successful management of a team
•Clinical trial monitoring, regulatory and legal experience
•Investigator, Advisory Board and Ad Comm Meeting coordinating experience
Archives: Speakers
Karim Sajwani
Lynn Manlapaz-Espiritu
Tony Tran, PhD
Anwar Mahmood
Anwar Mahmood has 16+ years of clinical system experience including IRT, CTMS, eCOA, and wearable device experience. He is currently a Director in the Clinical Technology Solutions Group at Exelixis where he oversees the IRT Team.
Gavin Choy
Julianne Feola
Sandeep Bhat
Alina Pszczółkowska
Alina Pszczółkowska is a medical graduate with a distinguished diploma in management from Polish Open University and Oxford Brookes University. Since 1997, she’s been involved with clinical research – working in Poland and in various global roles
After spending some time as acting physician she joined pharma industry and AstraZeneca in 1999, where she has held various leadership roles in clinical operations across site, study and programm management leading projects and organisations across the globe.
She also worked in Gothenburg, Sweden, overseeing delivery of cardiovascular, kidney, and gastrointestinal portfolio.
As of 2023, Alina is the Head of Late Phase Program Management organization in Respiratory and Immunology.
Alina is also the Site Leader of for AstraZeneca Cross functional site in Poland, and Vice-President at AstraZeneca Pharma Poland.