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Garry Sanders
Clinical Data Manager
Summary
Highly experienced Clinical Data Manager with a proven track record of managing and analyzing clinical data from multiple sources. Expertise in CDISC standards (SDTM, ADaM) for data transformation and harmonization. Strong understanding of regulatory affairs and clinical trial management. Collaborated with medical writers and statisticians to support clinical research and regulatory submissions.
Skilled in data quality assessment, data cleaning, and statistical analysis. Utilized statistical software (SAS, R) for data analysis and reporting. Participated in clinical trial monitoring and data verification audits. Coordinated data sharing and exchange with external partners and vendors.
Education
Master’s Degree in Clinical Research
April 2016
Skills
- Clinical Data Management
- Data Analysis
- Clinical Trial Management
- Regulatory Affairs
- Statistical Analysis
- Data Visualization
Work Experience
Clinical Data Manager
- Used statistical software (e.g., SAS, R) for data analysis and reporting.
- Collaborated with medical writers and statisticians to support clinical research and regulatory submissions.
- Participated in clinical trial monitoring and data verification audits.
- Coordinated data sharing and exchange with external partners and vendors.
Clinical Data Manager
- Managed clinical data from multiple sources, ensuring accuracy and completeness for 10+ clinical trials.
- Utilized CDISC standards (SDTM, ADaM) to transform and harmonize clinical data for regulatory submissions.
- Developed data management plans and implemented robust processes for data collection, cleaning, and analysis.
- Conducted data quality assessments and resolved data discrepancies to ensure data integrity.
Accomplishments
- Managed and streamlined a complex clinical database, reducing data entry errors by 30% and improving data quality.
- Developed and implemented a data management plan that ensured compliance with all regulatory and ethical guidelines.
- Collaborated with crossfunctional teams to integrate clinical data into a centralized repository, enabling realtime data analysis.
- Led the implementation of a new electronic data capture system, improving data collection efficiency by 25%.
- Conducted statistical analysis and generated reports to support clinical decisionmaking and study progress.
Awards
- Received the Society for Clinical Data Management (SCDM) Clinical Data Manager of the Year Award for outstanding contributions to the field.
- Recognized by the company for exceptional performance in developing and managing clinical data management systems.
- Received the Industry Excellence Award for outstanding contributions to the advancement of clinical data management practices.
- Recognized by the FDA for exceptional data management practices in a clinical trial resulting in successful drug approval.
Certificates
- Certified Clinical Data Manager (CCDM)
- SAS Certified Statistical Business Analyst
- Certified Associate in Project Management (CAPM)
- Certified Data Manager (CDM)
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How To Write Resume For Clinical Data Manager
- Highlight your experience in managing and analyzing large clinical datasets.
- Demonstrate your proficiency in CDISC standards and regulatory affairs.
- Showcase your skills in data quality assessment, data cleaning, and statistical analysis.
- Emphasize your ability to work independently and as part of a team.
Essential Experience Highlights for a Strong Clinical Data Manager Resume
- Managed clinical data from multiple sources, ensuring accuracy and completeness for clinical trials.
- Utilized CDISC standards (SDTM, ADaM) to transform and harmonize clinical data for regulatory submissions.
- Developed data management plans and implemented robust processes for data collection, cleaning, and analysis.
- Conducted data quality assessments and resolved data discrepancies to ensure data integrity.
- Used statistical software (e.g., SAS, R) for data analysis and reporting.
- Collaborated with medical writers and statisticians to support clinical research and regulatory submissions.
- Coordinated data sharing and exchange with external partners and vendors.
Frequently Asked Questions (FAQ’s) For Clinical Data Manager
What is the primary role of a Clinical Data Manager?
The primary role of a Clinical Data Manager is to manage and analyze clinical data from multiple sources, ensuring its accuracy and completeness. They play a critical role in clinical research and regulatory submissions.
What are the essential skills required for a Clinical Data Manager?
Essential skills for a Clinical Data Manager include data management, data analysis, clinical trial management, regulatory affairs, statistical analysis, and data visualization.
What is the importance of CDISC standards in clinical data management?
CDISC standards (SDTM, ADaM) provide a common framework for representing and exchanging clinical data. They help ensure data consistency, accuracy, and interoperability, which is crucial for regulatory submissions and data sharing.
What are the career prospects for a Clinical Data Manager?
Clinical Data Management is a growing field with excellent career prospects. Qualified professionals can find opportunities in clinical research organizations (CROs), pharmaceutical companies, biotechnology firms, and regulatory agencies.
How can I enhance my resume as a Clinical Data Manager?
To enhance your resume as a Clinical Data Manager, highlight your experience in managing large clinical datasets, your proficiency in CDISC standards and regulatory affairs, and your skills in data quality assessment, data cleaning, and statistical analysis.