Dedicated professional with 9 years of experience in document review, quality management, and compliance.
Skilled in utilizing interpersonal skills, time management, and problem-solving abilities to tackle professional challenges effectively.
Highly adept at collaborating with team members to expedite urgent requests while maintaining a strong focus on safety, accuracy, and confidentiality.
Advanced communicator capable of effectively engaging with team members, clients, management, and healthcare administrators.
Proficient in using Epic Healthwatch, Kroll, Cognizant, Oracle, CTMS, eTMF, SAP, and SIP.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Quality Assurance Specialist /Clinical Research Associate
Paraza Pharma Inc.
St. Laurent, Quebec
07.2022 - 04.2023
Completed comprehensive training on GCP, ICH guidelines, FDA and EMA regulations, and SOPs for regulatory compliance.
Managed clinical trial documentation with high accuracy, consistency, and regulatory compliance.
Implemented and maintained QMS, conducted audits, and drove process improvements.
Conducted site visits and audits to ensure compliance with protocols and guidelines.
Collaborated effectively with clinical teams, regulatory bodies, and stakeholders for efficient trial management.
Project Coordinator
Runnymede Healthcare Centre
Toronto, ON
12.2020 - 06.2022
Assisted in coordinating project activities, including scheduling, budget tracking, and resource allocation to ensure projects remained on schedule and within budget.
Acted as liaison between internal teams and external stakeholders, facilitating effective communication and collaboration throughout the project lifecycle.
Organized and participated in site visits, contributing to project feasibility assessments
Clinical Trials Assistant I
IQVIA- Partnership with Roche
Mississauga, Ontario
04.2020 - 11.2020
Assisted in maintaining CTMS fields, databases, tracking tools, timelines, and project plans with accurate project-specific information.
Managed CRFs, queries, and clinical data flow; conducted quality audits of study files, documents, and processes, escalating issues as needed.
Coordinated and submitted safety reports to regulatory authorities, marketing authorization holders, investigators, customers, and operations teams within deadlines.
Prepared and reviewed regulatory documents; managed and maintained the Trial Master File (TMF) to regulatory and company standards.
Prepared comprehensive progress reports for clinical trial review meetings; monitored protocol adherence, addressed deviations, and implemented corrective actions promptly.
Production Assistant Lead
Shopper Drug Mart/Specialty Network
Mississauga, ON
08.2016 - 03.2020
Reviewed prescriptions and documents for completeness, ensuring accurate record-keeping in compliance with pharmacy regulations.
Managed production and workflow triage to ensure efficient processing and timely medication delivery.
Entered demographic information, payer details, clinical notes, and prescriptions accurately into computer systems; generated medication labels for timely dispensing.
Prepared medications for pharmacist or technician review; oversaw packing, shipping, and courier waybill creation for cold chain and ambient medications.
Ensured regulatory compliance by filing dispensing documents, following up on deliveries, generating schedules, and coordinating with physicians’ offices for medication reorders.
Education
Bachelor of Science - Biotechnology
McMaster University
Hamilton, Ontario
06.2017
Diploma - Business Management
McMaster University
Hamilton, ON
09.2015
Certification
Principle of Biosafety I, 2013
Biosafety Level II, 2014
Six Sigma - White Belt, 2016
Project Management Certification, 2016
Good Clinical Practice (GCP)
Certification of Project Management
Clinical Code of Conduct Certification, 2020
Awards
McMaster University Entry Scholarship, 2010
Customer Service Leadership Award, 2008
Languages
English
Native or Bilingual
Hindi
Native or Bilingual
Urdu
Native or Bilingual
Punjabi
Native or Bilingual
Timeline
Quality Assurance Specialist /Clinical Research Associate
President & Head of Sub-Saharan Africa at Novartis Pharma Services / Novartis AGPresident & Head of Sub-Saharan Africa at Novartis Pharma Services / Novartis AG
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