Clinical Research Professional, Biotech, Pharmaceutical Research, CRO

Harman Grewal

Ontario, Canada ********@***.** 416-***-****

SUMMARY

Clinical Research Professional with over 4 years of experience managing and monitoring clinical trial operations from study start-up through close-out. Proven ability to navigate complex regulatory environments using a collaborative and multidisciplinary approach. Proven ability to ensure all stakeholders are aligned on project objectives, dedicating adequate time for risk planning and developing contingency strategies. Skilled in understanding the full scope of projects to identify and prevent scope creep, providing a proactive rather than reactive management style. Committed to advancing clinical research efforts to improve patient care while maximizing potential as a clinical research leader. SKILLS

• Led eTMF setup, maintenance, and closeout activities across multiple studies in compliance with ICH E6 (R2), GCP.

• Coordinated cross-functional communication between internal and external stakeholders, managing document collection, submissions, and maintained ongoing regulatory correspondence with Research Ethics, Health Canada, and FDA.

• Facilitated internal and external meetings, providing agenda items, and noting key updates and outcomes to all stakeholders.

• Developed and maintained study tracking tools, optimizing workflow efficiency and ensuring timeline and budget adherence.

• Demonstrated ability to thrive under pressure, consistently delivering high-quality work within timeline and budget constraints.

• Expert in managing regulatory authority recommendations while minimizing cost, schedule, and scope variances. EXPERIENCE

RTSM (IWRS) ASSOCIATE LEVEL II

Axiom Real-Time Metrics January 2024 – October 2024 Various Therapeutic Activities Etobicoke, ON

• Coordinated cross-functional communication between sponsor, site, and vendor teams, reaching all resource allocation milestones and adeptly managed timeline shifts and adjustments to recruitment and site activation plans.

• Consistently communicated with Project Management on adjustments to the Study Start-Up timeline and with Financial Analysts for financial forecasting, budget management, and supply management scope updates.

• Implemented milestone-driven eTMF systems to track and forecast required documentation, enabling proactive document collection and maintaining real-time TMF health metrics significantly reducing costly deviation and timeline adjustments. CLINICAL DATA ASSOCIATE

CMX Research Inc. September 2022 - September 2023

Bioavailability & Bioequivalence Remote

• Collaborated with PM team to obtain regulatory feedback as early as possible to develop preemptive solutions for potential regulatory hurdles. Developed risk mitigation workflows for protocol deviations, screen fails, and SAEs.

• Analyzed patterns and data anomalies from previous monitor reports and EDC audit trails to identify site inefficiencies, integrating findings into updated Clinical DM Plans to prevent budget, schedule, and scope creep.

• Authored and reviewed DM SOPs under GCP guidelines, developing associated training and competency testing.

• Executed all aspects of data cleaning and database lock procedures for study close-out, ensuring data integrity and compliance. PROJECT MANAGER

Pharma Medica Research Inc. February 2022 - June 2022 Bioavailability & Bioequivalence Mississauga, ON

• Coordinated cross-functional teams, fostering cross-site collaboration through centralized platform solutions. Eliminating silos reduced redundancies improved efficiency for regulatory document collection, consolidating responsibilities, communicating updates, and aligning milestone objectives to achieve faster FPI.

• Spearheaded the development of risk mitigation strategies and action plans, creating dashboard KPI Metrics with built-in optimization contingency plans triggered by critical threshold crossing providing complete transparency and accountability for all stakeholders resulting in fewer queries, lower screen failures, and reduced protocol deviations.

• Worked with software engineers to develop an automated response system for time consuming study activities from training programs for routine SOP updates, to nuanced protocol detail clarification, delivering cleaner flow of communication. RTSM (IWRS) ASSOCIATE LEVEL II and PROJECT MANAGER Axiom Real-Time Metrics Sept 2021 - February 2022

Various Therapeutic Areas Etobicoke, ON

• Proactively monitored study progress, adapting to ad-hoc changes, and implementing robust change management processes to prevent budget, schedule, and scope creep. Ensured documentation, reporting, and resolution of protocol deviations and issues related to study objectives.

• Trained study personnel on newly integrated systems. Provided ongoing support to site staff for performance optimization.

• Coordinated all SSU submissions and tasks as per contractual timeline/milestone deadlines. Delegated responsibilities for each properly trained study team member (confirm delegation of responsibilities) ensuring detailed communication plan are in place.

• Ensured GCP, SOP, and IATA TDG regulatory compliance in all inventory activities, meticulously overseeing documentation and accountability for study inventory from start-up through closeout.

• Reviewed invoice payments to identify double billing, incorrect coding, and overlooked expenses, enhancing cost-management deliverables.

GRADUATE RESEARCH ASSISTANT

Robarts Research Institute - Schulich School of Medicine May 2021 - September 2021 Schulich School of Medicine (Pulmonary Lab) London, ON

• Strengthened clinical trial management proficiency through personalized coaching sessions, refining project management and leadership soft skills, expertise in contemporary software and e-source systems to optimize clinical trial execution.

• Presented findings from extensive research/literature review on COPD, laying the groundwork for further research proposals. Facilitated follow-up meetings by creating agendas, and meeting minutes, and documenting the outcomes. IMAGE SERVICE COORDINATOR

Alimentiv (formerly Robarts Clinical Trials) June 2018 - March 2020 IBD (Ulcerative Colitis & Crohn's Disease) London, ON

• Serving as the key liaison and main point of contact, I adeptly delegated all site-level correspondence within strict turnaround times.

• Corresponded with the REB throughout the project duration (initial evaluation, amendments, SAE/SUSAR/AESI/DLT, annual renewal, etc.).

• Worked closely with the DM team to maintain a clean workflow database for smooth operations.

• Collected, reviewed, redacted, and stored endoscopy video data files within eTMF in compliance with ICH E6 (R2), GCP and ALCOA principles.

• Carefully reviewed screening compliance items: medications, previous treatments, medical charts, and doctor notes for inclusion/exclusion criteria, preventing potential protocol deviations and ensuring the trial's integrity.

• Provided comprehensive training and coaching, taking full responsibility for trainee performance and further training requirements.

• Coordinated and facilitated

• Delegated, escalated, and resolved lingering queries through cross-functional collaboration (with PM, QM, DM, logistics, lab).

• Provided consultation for site CRCs on protocol inquiries, study procedure clarifications, and troubleshoot support.

• Improved data quality through proactive collaborations with DM and Software Engineering teams to maintain a clean workflow database for smooth operations.

OTHER RELEVANT EXPERIENCE

Clinical Research Student Intern (Kidney Transplant Research) - St. Michael's Hospital 2017 – 2017 Trade Processor / Investor Relations – Citco (US) Hedge Fund Trades Administrator 2015 – 2016 Pharmacy Assistant – Metro Inc. 2010 – 2015

EDUCATION

Post-Degree Diploma in Clinical Trials Management

University of Western Ontario • London, Ontario • 2017 Notable Courses

Organization and Monitoring of Clinical Trials I & II Regulatory, Legal and Ethical Issues of Clinical Trials Reading and Understanding Research Information

Pharmacology for Clinical Trials

Financial Aspects of Clinical Trials

Communication Skills for Clinical Trials Manager

BSc Honors Kinesiology and Health Science

York University • Toronto • 2015

CERTIFICATIONS

Health Canada Division 5 - Drugs for Clinical Trials Involving Human Subjects CITI Program - St. Joseph's and St. Michael's Healthcare (N2) • 2021

• Comprehensively trained in regulations governing clinical trials involving human subjects. Transportation of Dangerous Goods TDG/IATA course - Canada CITI Program - Lawson Health Research Institute (N2) • 2021

• Certified expertise in handling and transporting hazardous materials in compliance with safety regulations. CITI Canada Privacy Course

CITI Program - Providence St. Joseph's and St. Michael's Healthcare • 2017

• Successfully trained in privacy regulations and ethical considerations, ensuring compliance with data protection standards to uphold participant confidentiality and integrity of study data.

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