Verified
This profile is verified using an email address.
Ginish Adlakha
Ottawa,Canada
Summary
Clinical Data Manager with deep expertise in data management for clinical trials, specializing in regulatory compliance and high-quality data maintenance. Demonstrated ability to manage complex projects and mentor teams, driving effective collaboration across clinical operations and biostatistics. Skilled in data visualization and analysis to support informed decision-making.
Overview
1
1
Certification
12
12
years of professional experience
Work History
Clinical Data Manager
Abbott Point of Care Canada
Ottawa, Canada
01.2021 - Current
- Successfully led and managed the entire data management process for 10 clinical trials, achieving a 100% on-time database lock while adhering to high quality standards, resulting in zero data discrepancies.
- Developed and maintained data management plans and EDC design to align with study protocols and regulatory requirements.
- Led regular data review meetings, analyzed and resolved data discrepancies, and implemented corrective actions.
- Utilize project management tools to track progress across multiple workstreams, observing that all activities are completed on time and within scope.
- Mentored data management teams, providing leadership and training to enhance project outcomes.
- Collaborated with cross-functional teams in clinical operations, biostatistics, and medical affairs to facilitate seamless study conduct and data integration.
- Contributed to the development of standard operating procedures (SOPs) and work instructions to streamline data management processes.
- Created visual data reports using Microsoft Power BI to enhance understanding of clinical data.
- Provided expert guidance on data management activities to ensure compliance and best practices.
Safety Writer
Novartis Healthcare
01.2020 - 06.2020
- Conducted quality review of ARs and PADERs, prepared for Health Authority inspections and audits, and developed Corrective & Preventative Actions (CAPA) to address safety findings, enhancing regulatory readiness.
- Led end-to-end preparation, publishing, and submission of Aggregate Safety Reports (ARs) for oncological drugs, ensuring compliance with regulatory standards.
- Supported operational excellence projects and implemented process improvements based on internal and external drivers, contributing to enhanced operational effectiveness.
Executive
Mylan Pharmaceuticals (Viatris)
05.2017 - 12.2019
- Oversee eCRF designing and annotation, database design specifications, and performing user acceptance testing (UAT) of the clinical database and edit check testing using RAVE.
- Developed risk management plans and conducted signal management activities including validation, prioritization, and assessment of signals, along with periodic reviews of safety data to identify potential signals.
- Prepared responses to regulatory authority questions on safety issues while liaising with global, regional, and local regulatory, quality, medical affairs, clinical research, commercial, and pharmacovigilance teams.
- Reviewed SAE reports, lab reports, ECG, imaging, pathology reports, and protocol deviations to ensure data accuracy.
- Led training and compliance metrics for project team members, escalating non-compliance or non-conformance to operating procedures.
- Maintaining and monitoring quality metrics and retraining team members on processes and procedures
- Conducting monthly team meetings, resolving team queries and issues, and training new recruits on clinical data management, tools practices and procedures
Analyst
Parexel International
01.2014 - 01.2017
- Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database.
- Verified source documents and reviewed CRFs, data listings, and databases to ensure compliance with protocol and data management plan, generating necessary queries.
- Developed proficiency in Electronic Data Capture systems (Medidata Rave, INFORM) and ad hoc query tools (J-Review) to manage local and central laboratory data.
- Managed Individual Case Safety Reports (ICSRs) including spontaneous, literature, and solicited types, interpreting data from RAVE forms and raising event-specific follow-up forms.
- Processed SAE and SUSAR into safety database according to clinical study protocol guidelines.
- Recognized for achieving the best quality standards in eCRF design in 2014-2015.
Education
Master of Business Administration (MBA) - Business Analytics
Carleton University
12-2027
Post-Graduation Diploma - Project Management
Maharashtra Institute of Technology
12-2018
Master's Degree - Master of Pharmacy
Kurukshetra University
12-2013
Bachelor's Degree - Bachelor of Pharmacy
Punjab Technical University
12-2011
Skills
- Clinical data management
- Electronic Data Capture systems
- EDC study designs
- CDISC Standards
- Good Clinical Practice
- Clinical Trial Management System
- Adverse event reconciliation
- Data management
- Data review
- Discrepancy Management
- CTCAE Grading
- Informed Consent Form
- Case report form
- Protocol
- SOPs
- Medical Monitoring Plan
- User Acceptance Testing
- Data Manipulation
- Data Visualization
- AWARE and ARGUS safety database
- MedDRA and WHO drug dictionary
- Project management
- Planning & Scheduling
- Budgeting
- Stakeholder Management
- Resource Management
- Change Management
- Project Initiation
- Project Closing
- Training
- Strategic Delegation
- Workload management
- Strong problem solving
- Analytical reasoning
- Decision-making skills
- Effective communication
- Conflict Resolution
- Active listening
- Microsoft Power BI
- Project management
- Microsoft Power BI
Certification
- Certified Clinical Data Manager (CCDM), Society for Clinical Data Management (SCDM), 01/28
- Project Management Professional, Project Management Institute, 01/29
- Google Data Analytics, Google, 01/24
- IBM Clinical Development Designer, IBM, 01/21
- Good Clinical Practice (GCP), CITI Program, 01/21
- Clinical Data Science, University of Colorado, 01/24
Timeline
Clinical Data Manager
Abbott Point of Care Canada
01.2021 - Current
Safety Writer
Novartis Healthcare
01.2020 - 06.2020
Executive
Mylan Pharmaceuticals (Viatris)
05.2017 - 12.2019
Analyst
Parexel International
01.2014 - 01.2017
Master of Business Administration (MBA) - Business Analytics
Carleton University
Post-Graduation Diploma - Project Management
Maharashtra Institute of Technology
Master's Degree - Master of Pharmacy
Kurukshetra University
Bachelor's Degree - Bachelor of Pharmacy
Punjab Technical University