Nishan Balakumar

** **** ***** ********, *******, ON M1S 3Z8 C: 647-***-**** ac2ti3@r.postjobfree.com

PROFESSIONAL SUMMARY

Focused Senior Analyst with 5 years in-depth knowledge in Clinical Research and 10 year of experience in Healthcare Research & Patient Recruitment.

SKILLS

WORK HISTORY

Senior Business Process & Data Analyst, UHN Digital - Data & Implementation Science - PMO July 2017 to Current

University Health Network (UHN) – Toronto, ON

Lead Quality Improvement projects across UHN hospital sites (Princess Margaret, Toronto General & Toronto Western)

Provide implementation and post implementation support to end users through educational training

Develop business requirements and solution scope by utilizing data science

Lead designing of data collection processes, workflow analysis, reporting and data visualization activities

Handle end-to-end project management, stakeholder communication, resource allocation, analysis and on-time quality delivery

Lead a team of 1-2 analysts to ensure milestones and timelines are in intact

Perform standard application testing (unit testing), data and systems analysis

Manage and ensure projects were successfully completed within allocated capital budget

Collaborate with internal and external stakeholders to ensure suitable execution of projects

Senior Clinical Systems Specialist, Feb 2016 to August 2017

Inflamax Research Inc – Mississauga, ON

Design, implementation and coordination of all aspects of audio/visual, data collection and CRF transcription as per protocol, SOPs, ICH/GCP guidelines and 21 CFR Part 11

Lead clinical specialists to ensure clinical trial timelines and milestones are met

Global setup and on-site training end user training pertaining patient recruitment, report generation, and any validated electronic data capture (EDC) or ePDAT/ePRO systems being managed by the CS department

Design and submission of departmental institutional Review Board (IRB) documents

Field monitoring and analysis of clinical trial data

Support data management by utilizing business intelligence tools (e.g. Crystal Reports)

Engaging in pre-study meetings regarding protocol development, clinical recommendations and patient enrollment

Attending site initiation visits (SIV) and sponsor visits to provide subject matter expertise in CS maintained systems and applications

Interacting with Principal Investigator, sponsor, project manager, QA, regulatory staff, CRA, scientific director and other study coordinators to ensure all aspects of protocols and study requirements were met or exceeded client expectations

Clinical Systems Specialist, Dec 2014 to Feb 2016

Inflamax Research Inc. – Mississauga, ON

Creation, implementation and management of Clinical Systems Project Plan

Assist with the IQ/OQ, calibration, training and documentation review for project implementation of all CS equipment and systems validations

Develop and execute test scripts as well as assist with all aspects of any CS validation in compliance with appropriate Inflamax SOPs, GLP, GDP, and ICH guidelines

Preparation and oversight of any administrative systems managed by the CS department used to facilitate the management of study patients

Identification, source and validate any novel equipment or systems required for project conduct and assess impact of efficiency improvements

Prepare and execute Environmental Exposure Chamber (EEC) validations and Re-Qualifications

Clinical Research Coordinator II, Nov 2013 to Dec 2014

Inflamax Research Inc. – Mississauga, ON

Assisted in the overall coordination of clinical studies for BE and Phase 1-4 studies

Performed clinical and study procedures as per study protocols, ensuring minimal deviations and proper tracking and reporting when deviations occur

Lead clinic operational study briefings and interacted with various departments and other study coordinators to ensure all aspects of protocols and study requirements were met or exceeded client expectations

Assisted in design, implementation and coordination of source documentation and CRF transcription as per protocol, SOPs and ICH/GCP guidelines

Participated in development and execution of Quality Control processes

Prepared and supported QA audits and sponsor monitoring visits

IRB interactions; Site Regulatory Documentation collection and management

Recruiting & Screening Coordinator, May 2012 to Nov 2013

Pharma Medica Research Inc. – Scarborough, ON

Completed documentation of clinical activities according to GCP, SOP guidelines and EDA/TPD regulation

Recruited, screened, and coordinated patient visits using CDMS (Clinical Data Management System) as per study protocols

Strong technical knowledge of pharmaceutical manufacturing, quality assurance, GMP,ISO, ICH guidelines

Medical Market Researcher and Recruiting Supervisor, 07/2007 to 01/2017

Quality Response Inc. – Toronto, ON

Recruited/pre-screened doctors and other healthcare professionals into qualitative and quantitative research studies

Conducted in-home patient interviews/focus groups and complied research reports for clients

Managed company’s Medical and Consumer Database

EDUCATION

Honours Bachelor of Science: Integrated Human Biology, 2012

Double Major: Life Sciences & Music Culture

University of Toronto – Scarborough, ON

CERTIFICATIONS

Aspiring member of SOCRA (Society of Clinical Research Associates)

Health Canada Division 5 – Drugs for Clinical Trials Involving Human Subjects Certification

CITI Canada Certifications (GCP, Privacy & Dangerous Goods)

Healthcare Community Involvement (Rouge Valley Healthcare, Princess Margaret Hospital, Markham Stouffville Hospital & Providence Healthcare)

Contact this candidate