Lyndsay Rayner

EDUCATION
Clinical Research Graduate Certificate September 2018 – August 2019
Humber College, Toronto, Ontario
Master of Science, Molecular Biology & Genetics September 2016 – July 2018
McMaster University, Hamilton, Ontario
Bachelor of Science, Honours Psychology, Neuroscience & Behaviour September 2012 – April 2016
McMaster University, Hamilton, Ontario

WORK EXPERIENCE
Global Study Manager – Oncology February 2022 – Present
AstraZeneca, Mississauga, Ontario
• Build and maintain partnerships with functional teams both internally and externally to ensure successful study delivery
• Support global recruitment through collaboration with local study leads to proactively identify country specific
issues (vendor supply /budget /regulatory submissions, etc) to streamline RTE/recruitment timelines
• Act as SME for recruitment GSM pillar; facilitate monthly network meetings to enhance cross-collaboration within the
Poland/Toronto hubs, to promote the optimization and standardization of recruitment strategies across oncology studies
• Lead and contribute to the maintenance of delegated study documents such as the Informed Consent Form, monitoring
plan, PD plan, as well as external service provider related documents such as specifications and budget agreements
• Lead the successful set-up and delivery of TEMPUS recruitment vendor in the US, established a new central vendor
start-up workflow allowing for rapid site activation and patient enrollment
• Management of third party vendors; act as point of contact between vendor and AZ teams, implementing appropriate
mitigation efforts and ensuring the timely resolution of issues to meet study deliverables
• Support Global Study Director with budget management, such as vendor invoice reconciliation and processing of budget
amendments within the AZ purchasing system (COUPA), contributing to study budget adherence
• Contribute proactively to risk and issue identification and development of mitigation and/or action plans, ensuring study
quality and inspection readiness
• Participated in the AZ Buddy program, acting as mentor to facilitate streamlined onboarding of new hires into AZ culture
and company specific processes and systems
Clinical Research Project Coordinator – Haematology/Oncology January 2021– February 2022
The Hospital for Sick Children, Toronto Ontario
• Prepared and managed the submission of regulatory documents (protocol amendments, consent forms, REB application
packages) for ethics review throughout the lifecycle of the study
• Coordinated with clinical team to ensure the timely consenting and enrollment of eligible patients onto study protocol
• Monitored study compliance, collaborated with clinical staff to ensure completeness and accuracy of study
documentation, including collecting and reporting of adverse events to internal/external regulatory bodies as needed
• Assisted with tracking study budgets, collaborating with study budget associate as necessary to ensure adherence to
budget
• Ensured the timely entry of data into various electronic data capture systems, including Medidata Rave, Oracle Inform,
and OpenClinica
• Established positive relationships with internal and external stakeholders, enabling study continuation and success
Clinical Trial Coordinator – Medical Device August 2020 – October 2020
MolecuLight Inc., Toronto Ontario
• Evaluated the progress of assigned study by tracking regulatory submissions and approvals, recruitment and enrolment,
Case Report Form (CRF) completion and submission, and data query generation and resolution
• Performed remote-based monitoring visits to ensure study was conducted in compliance with the approved protocol/
amendment(s), with current GCP guidelines and applicable regulatory requirements
• Maintained the Trial Master File (TMF) for assigned study, including appropriate regulatory approvals, credentials, and
training documentation; ensured TMF was inspection-ready throughout study duration
• Acted as point of contact for sites; identified and proactively supported sites in resolving issues as they occurred
Clinical Research Coordinator – Dermatology December 2018 – August 2020
Dermetics, Burlington Ontario
• Managed assigned dermatology-based studies; pro-actively planned, drove and tracked execution and performance of
deliverables/timelines/results to meet study commitments from site selection, recruitment, execution and close out
• Performed source data verification, ensured on-site study drug storage, dispensing, and accountability, data collection
and regulatory document maintenance
• Accelerated efforts to identify additional patient population; enabled trial to re-open for enrollment in October 2019
• Created and implemented source documentation and SOPs in compliance with Health Canada, FDA and ICH/GCP
regulatory standards, which were incorporated and endorsed by the Sponsor for use at additional sites
Research Assistant II September 2018 – December 2018
McMaster University, Hamilton Ontario
• Implemented CRISPR/Cas9 gene editing in the laboratory and taught all lab personnel design principles; led to novel
gene knockouts in breast cancer cell lines and further characterization of triple negative breast cancer (TNBC) subtype
• Collaborated with a PhD student to identify novel roles for the transcription factor Kaiso as a positive regulator of TNBC
cell growth, proliferation and metastasis; resulted in co-authorship of manuscripts accepted and published by the peer-
reviewed journals “Oncogenesis, Cell Death and Disease, Cancer Causes & Control, and PLoS ONE”
• Trained graduate and undergraduate students on appropriate molecular biology techniques and implemented laboratory
SOPs; led to protocol standardization within the lab greatly enhancing reproducibility
Clinical Trial System Experience
• CTMS: Oracle, Veeva Vault, (Veeva Clinical Vault, Veeva Quality Vault) RAVE CTMS
• EDC: Oracle RDC, Medidata Rave, Inform, OpenClinica, REDCap
• eTMF: Veeva Vault
• EMR: Accuro, Epic