Neeraj Kadian
Glenroy,VIC
Summary
Dynamic professional with a proven track record at Biotech Study and Research Centre, adept in biological data interpretation and leveraging computational tools for drug safety monitoring. Excelled in clinical trial oversight and enhanced communication strategies, achieving significant workflow optimizations. Skilled in dataset management and client relationship management, consistently delivering results beyond expectations.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Office Administrative Assistant
Bajwa Immigration Consultants
Melbourne, Australia
08.2022 - Current
- Support administrative tasks, data organization, meeting coordination, and communication management.
- Ensure research record accuracy and compliance with regulations, contributing to efficient workflows.
- Assist with client queries by staying updated on current migration regulations.
- Delivered excellent customer service, resolving client issues and complaints effectively.
- Greeted visitors and answered incoming calls, providing information to callers or redirecting them to the appropriate personnel.
- Assisted with scheduling meetings and appointments for the office staff.
- Created expense reports, tracked invoices, and processed payments.
Drug Safety Associate
Biotech Study and Research Centre
Panchkula, India
03.2021 - 01.2022
- Analyzed complex biological data using computational tools to identify patterns and support research in healthcare and biotechnology.
- Generated data-driven recommendations for drug development and biotechnology initiatives.
- As a Drug Safety Associate, I monitored and assessed pharmaceutical product safety, reported adverse reactions, maintained safety databases, and ensured regulatory compliance, all contributing to patient safety by identifying and mitigating drug risks.
- Also, as a Clinical Research Associate (CRA), I monitored clinical trials, ensured compliance with regulations, oversaw data accuracy, maintained documentation, and collaborated with investigators to provide ethical and efficient trial conduct.
- Contributed to the development of Standard Operating Procedures related to Pharmacovigilance activities.
- Developed training materials on Drug Safety topics for use by other departments within the organization.
- Coordinated international exchange programs between countries regarding drug safety matters.
- Conducted periodic review of adverse event reports to assess accuracy and completeness of information.
- Maintained accurate records of drug safety data in accordance with regulatory requirements.
- Formulated strategies for adverse event collection and analysis.
- Monitored clinical trials for safety signals and identified potential safety issues.
- Ensured compliance with drug safety regulations by collaborating with Regulatory Affairs, Clinical Research, Quality Assurance and Quality Control departments.
- Reviewed literature sources such as published scientific articles, abstracts, press releases and FDA public advisories related to drug safety topics.
- Prepared detailed summaries of serious adverse event cases for submission to regulatory agencies worldwide.
- Evaluated pharmacovigilance data from multiple sources including spontaneous reports and clinical trial databases.
- Participated in internal audits of Drug Safety processes and procedures.
- Performed trend analysis on post-marketing surveillance data to identify patterns or clusters of adverse events associated with a particular drug or therapeutic class.
- Communicated effectively with healthcare professionals regarding Drug Safety inquiries.
- Researched relevant medical literature concerning new drugs and indications; assessed their impact on existing products.
Clinical Research Associate
Biotech Study and Research Centre
Panchkula, India
12.2018 - 03.2020
- Conducted in silico drug design for elephantiasis using bioinformatics tools (NCBI, BLAST, MODELLER, PyMOL, AUTODOCK).
- Monitored pharmaceutical product safety and maintained drug safety databases in compliance with regulations
- Collaborated with investigators to ensure clinical trial compliance, and data accuracy.
- Performed detailed data analysis in a biology and life sciences research environment
- Conducted computational modeling using algorithms and analytical tools to support drug design and target identification
- Contributed to research programs by improving methodologies and enhancing service delivery within the biotech center
- Performed clinical research activities including protocol development, subject recruitment and data collection.
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Developed and managed budgets for clinical trials according to study protocols.
- Coordinated the submission of regulatory documents to IRBs and ECs and other relevant authorities.
- Conducted site initiation visits and monitored ongoing studies at investigator sites.
- Assessed incoming source documentation for accuracy and completeness against case report forms.
- Provided support in writing informed consent forms, patient diaries, study manuals.
- Ensured proper storage of investigational product at investigator sites per GCP guidelines.
- Interacted with sponsors, CROs, investigators, vendors and subcontractors as needed.
- Prepared reports summarizing study progress and results for senior management review.
- Monitored safety events reported during the course of clinical trials in accordance with SOPs.
- Ensured timely completion of all deliverables by tracking project timelines and milestones.
- Drafted agendas, minutes and other meeting materials for Investigator Meetings or Advisory Boards.
- Tracked enrollment status across multiple sites to ensure target goals were met in a timely manner.
- Provided training on GCP standards to new personnel or existing staff members.
- Managed relationships with external vendors such as laboratory services or imaging centers.
- Maintained accurate records of all regulatory submissions, correspondence and approvals received from local ethics committees or regulatory agencies.
- Adhered to good clinical practices, operating procedures and regulatory requirements.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
- Performed pre-study, closeout and interim visits to check on study activities.
- Attended investigator meetings to provide framework for successful research studies by establishing responsibilities.
- Ensured documentation and communication adherence to project standards.
Data Analyst
Eclerx Services Ltd.
Chandigarh, India
04.2017 - 12.2018
- Ensured bioinformatics data compliance with industry standards.
- Analyzed large datasets to identify trends, patterns and correlations for business insights.
- Gathered requirements from stakeholders to design data models and reports.
- Leveraged SQL queries to extract, transform and load data into databases.
- Conducted exploratory analysis of complex datasets using Python libraries such as NumPy and Pandas.
- Optimized existing database structures for better performance on analytics tasks.
PGT Biology Teacher
C.R. Senior Secondary School
Majra, India
02.2015 - 08.2016
- Instructed senior secondary students in advanced biology.
- Implemented collaborative methods to boost scientific learning.
- Assessed student performance and provided feedback in order to promote academic growth.
- Developed lesson plans based on state curriculum guidelines to ensure learning objectives were met.
- Conducted laboratory experiments and field trips to enhance student understanding of biology concepts.
Education
Advanced Diploma of Leadership and Management - strategic leadership, change management, financial planning, risk management
Nova College
Melbourne CBD, Australia03.2024
Diploma of Leadership and Management - leadership, communication, project management, conflict resolution skills
Nova College
Melbourne CBD, Australia03.2023
M.Sc. - Bioinformatics
Panjab University
Chandigarh, India05.2014
B.Sc. - Medical Sciences
Maharshi Dayanand University
Rohtak, India04.2012
Skills
- Biological data interpretation
- Computational tools
- Drug design
- Molecular modeling
- Dataset management
- Drug safety monitoring
- Clinical trial oversight
- NCBI
- BLAST
- PyMOL
- AUTODOCK
- Bioinformatics
- Communication
- Database entry
- Proofreading
- Workflow optimization
- Leadership and supervision
- File organization
- Site management
- Monitoring visits
- Project monitoring
- Interdepartmental collaboration
- Coordinating site operations
- Research and development
- Team Training
- Report writing
- Drug development
- Detailed documentation
- Patient safety
- Patient recruitment strategies
- Protocol adherence
- Completing regulatory documents
- Clinical documentation
- Reviewing data standards
- Coordinating supplies
- Action planning
- Interactive management
- Status reporting
- Risk management
- Clinical trials
- Cell culture
- Medical imaging
- Time management
- Genetic engineering
- Attention to detail
- Critical thinking
- Protocol development
- Decision-making
- Study planning
- Research management
- Written communication
- Safety management
- Problem-solving aptitude
- Team collaboration
- Organizational skills
- Reliability
Certification
- In Silico Drug Designing (Elephantiasis Disease) - Adibiosolution, Mohali
- Role of E-Resources in Scientific Research - S.D. College, Chandigarh
- PERL Programming Language - Adibiosolution, Mohali
- Diploma in Advanced Certificate in Information Technology - National Service Scheme
- ICH Good Clinical Practice E6 (R2) - VCCC Alliance
- Training Disease Assessments in Clinical Trials VC.5 - VCCC Alliance
- Training Clinical Trials in Practice VC.01 - VCCC Alliance
- Project on In Silico Structure Based Drug Designing of Potent Inhibitor BCR-ABL Tyrosine Kinase.
References
References available upon request.
Timeline
Office Administrative Assistant
Bajwa Immigration Consultants
08.2022 - Current
Drug Safety Associate
Biotech Study and Research Centre
03.2021 - 01.2022
Clinical Research Associate
Biotech Study and Research Centre
12.2018 - 03.2020
Data Analyst
Eclerx Services Ltd.
04.2017 - 12.2018
PGT Biology Teacher
C.R. Senior Secondary School
02.2015 - 08.2016
- In Silico Drug Designing (Elephantiasis Disease) - Adibiosolution, Mohali
- Role of E-Resources in Scientific Research - S.D. College, Chandigarh
- PERL Programming Language - Adibiosolution, Mohali
- Diploma in Advanced Certificate in Information Technology - National Service Scheme
- ICH Good Clinical Practice E6 (R2) - VCCC Alliance
- Training Disease Assessments in Clinical Trials VC.5 - VCCC Alliance
- Training Clinical Trials in Practice VC.01 - VCCC Alliance
- Project on In Silico Structure Based Drug Designing of Potent Inhibitor BCR-ABL Tyrosine Kinase.
Advanced Diploma of Leadership and Management - strategic leadership, change management, financial planning, risk management
Nova College
Diploma of Leadership and Management - leadership, communication, project management, conflict resolution skills
Nova College
M.Sc. - Bioinformatics
Panjab University
B.Sc. - Medical Sciences
Maharshi Dayanand University
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