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Harman Grewal

Ontario, Canada ad1p39@r.postjobfree.com 416-***-****

SUMMARY

I am a dedicated clinical research professional with four years of experience in training and managing global clinical trial operations. My passion for this industry is matched by the expanding regulatory recognition of pioneering clinical software and AI solutions catalyzed by the challenges spurred on by the upheaval of COVID-19. I am seeking to join a like-minded, innovative organization to capitalize on an environment of ever-evolving global regulations, increased globalization and redefined stakeholders, to achieve measurable (KPI) goals that far exceed what was previously achievable. SKILLS

• BSc Honors Kinesiology & Health Science. Postgraduate Diploma in Clinical Trials Management.

• Advanced knowledge of ICH-GCP, FDA, and Health Canada regulations and guidelines.

• Eager to learn and adapt, I often seek opportunities to acquire new skills that contribute to efficiency, cost-effectiveness, and quality improvements.

• Highly proficient in Microsoft Office, (OneNote, Excel, Outlook) trial management systems and PM software.

• Excellent communication and interpersonal skills to effectively work with cross-functional teams.

• Self-motivation with a keenness toward building collaborative relationships to achieve results. EXPERIENCE

CLINICAL DATA ASSOCIATE CMX Research Inc. - Bioavailability & Bioequivalence September 2022 - September 2023, (Part-Time) Remote

• Conceptualized patient eCRFs and database schema per protocol specifications and GCP compliance.

• Accurately and efficiently validated EDC pages. Triggered queries on missing data and data points failing pre-defined range checks.

• Completed all database lock milestone items for multiple studies with precision resulting in 0 data discrepancies.

• Validated and distributed study progress status reports to internal and external study team members throughout the study. PROJECT MANAGER Pharma Medica Research Inc. - Bioavailability & Bioequivalence February 2022 - June 2022,Mississauga, ON

Unable to continue due to COVID-19

• Coordinated study start-up activities between various departments, i.e., obtaining milestone completion dates to build study activation timeline.

• Developed preemptive solutions for potential regulatory hurdles to meet all contractual commitments and milestone dates.

• Collected and submitted pre-study documents to the regulatory team for review by REB. Monitored regulatory approval progress toward study initiation.

• Generated reports with analytics regarding overlooked budgeted expenses, increasing savings in operational costs.

• Introduced process improvement management system, Veeva Vault, and AI software app, VersaTrial to streamline study organization (regulatory submissions, TMFs, study correspondences etc.) and elevate the quality of delivery standards. RTSM (IWRS) ASSOCIATE LEVEL II and PROJECT MANAGER Axiom Real-Time Metrics - Various Therapeutic Areas September 2021 - February 2022, Etobicoke, ON

• Developed global SOPs ensuring local regulatory compliance and harmonization.

• As the single point of contact, I provided complete life-cycle management for all clinical supply management matters from inventory forecasting and planning through reconciliation ( of returned products) and destruction.

• Solved product packaging, labelling and release process problems and efficiently navigated challenging local import and export regulations. GRADUATE RESEARCH ASSISTANT Robarts Research Institute - Pulmonary Research May 2021 - September 2021, London, ON

• Refined my expertise as a clinical research professional; assigned difficult challenges and completed specialized tasks to improve the nuanced soft and technical skills (such as eCTD submission planning and tracking) required to manage global clinical trials in various therapeutic areas.

• Analyzed and presented compelling reports on public health data to address the need for new pulmonary research.

• Strengthened risk assessment skills for proactive issue resolution and managing change orders efficiently. Fostered a forward-thinking mindset for long- term success in clinical research.

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IMAGE SERVICE COORDINATOR Alimentiv - IBD (Ulcerative Colitis & Crohn's Disease) June 2018 - March 2020, London, ON

• Acted as the point of escalation for the resolution of site staff and project-related issues. Provided subject matter expertise for study data and query reconciliations.

• Decisive participant in internal and sponsor team meetings, working closely with PM, DM, QA, and Logistics team members.

• Ensured study documents were recorded, filed and maintained in TMF as per SOPs and regulatory guidelines.

• Reviewed, signed, and implemented SOP updates and associate documents to enhance efficiency and data integrity. Collaborated with the QA team to oversee change management processes.

CLINICAL RESEARCH STUDENT INTERN St. Michael's Hospital - Kidney Transplant Research June 2017 - October 2017, Toronto, ON

• Surreptitiously collaborated with the dedicated research staff responsible for my mother’s dialysis and kidney transplant care when I was young. It fostered a mentorship that continues to inspire and guide my personal and professional growth.

• Approached selected potential subjects from St. Michael's Hospital to facilitate the informed consent process and acquired ICF signatures.

• Transferred survey and questionnaire source data into EDCs/eCRFs after conducting patient visits. Performed SDV and reconciled data discrepancies and query resolution.

• Learned how regulatory guidelines interact with everyday research practices. TRADE PROCESSOR/ INVESTOR RELATIONS Citco

March 2015 - May 2016, Toronto, ON

PHARMACY ASSISTANT METRO PHARMACY

August 2010 - February 2015,Mississauga, ON

EDUCATION

Post-Degree Diploma in Clinical Trials Management University of Western Ontario London, Ontario, 2017

BSc Honors Kinesiology and Health Science York University Toronto, 2015

CERTIFICATIONS

Health Canada Division 5 - Drugs for Clinical Trials Involving Human Subjects CITI Program - Providence St. Joseph's and St. Michael's Healthcare (N2)

2021

Transportation of Dangerous Goods TDG/IATA course - Canada CITI Program - Lawson Health Research Institute (N2) 2021

CITI Canada Privacy Course CITI Program - Providence St. Joseph's and St. Michael's Healthcare 2017

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