Ashley Mischitelle Email & Phone Number

Toronto, On, Ca

Boston, Massachusetts, Us

Boston, Massachusetts, Us

Leading the RBQM process in eligible studies in the Alexion AstraZeneca Rare Disease Development HubEngaging project teams, global and local study steams during initial stages of studies in order to develop study specific critical to quality factors, acceptable defect rates, quality tolerance limits and risk management strategies

Switzerland 🇨🇭 , Ch

Product Lead for RBQM Embedding Mindset and Behaviours and RBQM lead on the DSD Data Review Strategy team; working closely with PLs and product experts for Data Quality Oversight, QTLs, KRIs and Central Monitoring, CRLs to shift the way we approach studies and data reviewLeading the global approach to embedding RBQM mindset within the organization and working closely with the central risk leaders to ensuring it is applied effectively at the study levelProgram Data Leader – overseeing DSD activities at the molecule level; provides strategic direction and DSD leadership at the clinical development program level and ensuring alignment within the programStudy level - Data Quality Lead and Study Leadership Team representative for Data Sciences in late phase oncology trials

Switzerland 🇨🇭 , Ch

Team lead for Quality Tolerance Limits and Statistical Monitoring; Strategic partnering with PDQ to assist in providing data in setting global QTLs Program Data Leader and Biometrics Team Manager for the pediatric oncology program Led multiple study teams; communicated study timelines and deliverables to all CDM study team staff and follows up to ensure timely delivery of assigned tasks

Switzerland 🇨🇭 , Ch

RBM Deployment Liaison for onboarding new studies onto the RBM model RBM Biometrics Change Champion Lead – team of 15 global individuals contributing and driving the implementation of RBM throughout the organizationResponsible for proactive risk identification, risk mitigation, prioritization and timely issue resolution for my studies; actively participated as an early-adopter for Risk Based Monitoring and provided feedback on the processLed the CDM study team and maintained oversight over the build and conduct of multiple studiesExperienced in all aspects of study activities including, build, conduct and close ensuring fit for purpose quality

Toronto, Ontario, Ca

Toronto, Ontario, Ca

Department of Psychosocial Oncology and Palliative CareManaged a mixed-methods, longitudinal clinical research study involving acute leukemia patients assessing traumatic stress and physical symptom burdenTrained and supervised volunteers, summer and Masters studentsCollaborated and liaised with an interdisciplinary team of stakeholders, including the principal investigators, hematologists, nursing manager, social workers, and various departmental staff

Toronto, Ontario, Ca

Department of Surgical Oncology; UrologyIdentified and assessed patient eligibility; recruited and enrolled eligible patients into clinical trials and monitored compliance in investigator-driven trials in the Division of Urology Worked closely with physicians, clinical and nursing staff in urology, biopsy, medical oncology and radiation oncology clinicsAssisted with the development of database schemas for the GU BioBank team; provided information and data to the UHN DSMB

Post-Graduate Diploma, Clinical Research

Bachelor Of Science - Bs, Biology, Psychology