Kyle Francis Velayo Email & Phone Number

Mississauga, On, Ca

Mississauga, On, Ca

Hamilton, Ontario, Canada

I am currently working as Research Coordinator/Clinical Data Manager for the COMPLETE-2 study, primarily in the data management side of the study (CRF Creation, EDC systems, Report Creation, Data Governance/Compliance, Manual Creation, Event Reporting).Responsibilities:• Developed and maintained essential study documents (Protocol, Data Management Plan, Protocol Deviation Plan, CRF Templates, Site Worksheets).• Ensured ethical and regulatory compliance in all data management activities.• Created CRFs and EDC systems adhering to ICH GCP and CDISC/CDASH standards.• Collaborated with clinical data operations, biostatisticians, and programmers to generate and validate SAS and ad hoc reports, reducing data cleaning and validation time by 30%.• Identified and mitigated data management risks during CRF/EDC development and upgrades.• Authored guidelines for data management processes, including EDC manuals, CRF Completion Guidelines, and data quality review and monitoring plans.• Spearheaded the development, UAT, and implementation of mid-study changes and database modifications, minimizing risks to study data.• Optimized data management processes by facilitating seamless and structured data validationprocedures and delegating data cleaning responsibilities effectively to junior data personnel.• Managed a team of junior data management personnel, significantly improving efficiency.• Conducted interviews and training sessions to mentor junior staff on study procedures and data management expectations.• Programmed and tested edit checks and data validations using JavaScript and HTML.• Contributed to the implementation of efficient data standards for clinical studies as part of an organizational-wide initiative and actively participated in a dedicated data standards working group to establish a robust data governance framework.• Recognized as an organizational leader and a Subject Matter Expert in clinical data management and Anju Software TrialMaster.

Hamilton, Ontario, Canada

Hamilton, Ontario, Canada

Worked as a Research Assistant for Alexion Pharmaceuticals' ANNEXa trial. Responsibilities:• Liaised with study stakeholders, including statisticians, programmers, sponsors, monitors, and site personnel.• Validated summary lists and reports for interim analyses and DMC/DSMB review.• Managed clinical trial data, including data transfers, query resolutions, SAE reconciliation, and report validation and analyses.• Assisted the designated medical coder (in MedDRA and WHODD) coding of medical history events, SAEs, and concomitant medications.

Mississauga, Ontario

Adept in working multiple positions within the store including: cashier, stock and inventory management, fitting room/alterations, and sales floor representativeProficiently performed various tasks pertaining to daily operations and maintenance of the storeDemonstrated strong interpersonal skills by working efficiently with other team members/colleagues and ensuring customer service and satisfaction

Hamilton, Ontario

Assisted the COMPLETE study team in creating adjudication dossiers/packages, validating case reports forms, ensuring data quality and integrity, and managing correspondences throughout the world in a multi-national cardiac clinical trial

Mississauga, Ontario

Effectively stocked and refreshed various kinds of frozen and dairy products Accurately placed inventory orders and received shipment orders from suppliers Demonstrated strong intrapersonal and organizational skills through excellent customer service and assistanceMaintained a tidy and safe environment for customers to shop in during daily operations

Bachelor Of Science (B.Sc.), Biochemistry And Molecular Biology, Summa Cum Laude

Acquired McMaster Entrance Award scholarship and Dean’s Honour Lists Successfully graduated with the highest distinction: summa cum laude.

Post-Graduate Certificate, Clinical/Medical Laboratory Science/Research And Allied Professions, 4.0 Gpa

Courses include: Pharmacology, Introduction to Drug Design and Clinical Trials, Clinical Trial Administration, Clinical Trial Regulations.

Ontario Secondary School Diploma