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Clinical data management manager skills for your resume and career
15 clinical data management manager skills for your resume and career
1. GCP
Google Cloud Platform (GCP) is a collection of cloud computing services that allow users to develop, deploy, and operate original applications on the web. GCP carries a cloud computing infrastructure that facilitates it in keeping track of the resources (e.g., storage, processing speed, and power, network connectivity, database queries, etc.) of an application or a website, whenever it is run on the cloud platform.
- Developed operational workflows, guidances, and SOPs to ensure compliance with GCP standards.
- Reviewed data from a global Phase III cardiovascular trial to verify adherence to study protocol and ICH GCP.
2. Data Management
The administrative process that involves collecting and keeping the data safely and cost-effectively is called data management. Data management is a growing field as companies rely on it to store their intangible assets securely to create value. Efficient data management helps a company use the data to make better business decisions.
- Collaborate with all Therapy Area Managers to develop and implement standard processes for global consistency within data management across the organization.
- Ensured on-time project goal achievement by delivering study data and obtaining timely team inputs and cooperation for clinical data management activities.
3. Clinical Research
- Develop standards for data entry and queries to resolve database issues, working with the clinical research associate.
- Generated queries, working with the clinical research associate to resolve database issues.
4. CRO
A CRO (Cathode Ray Oscilloscope) refers to an electrical device usually used in a laboratory to exhibit, measure, and analyze different waveforms of electrical circuits.
CRO may also refer to Conversion Rate Optimization -- the practice of improving a process or product to maximize the number of conversions or sales.
- Delivered comprehensive system, process and role-specific training for new contract research organization (CRO) staff.
- Interpret, synthesize and present technical information to CRO management and pharmaceutical and biotechnology clients.
5. Data Collection
Data collection means to analyze and collect all the necessary information. It helps in carrying out research and in storing important and necessary information. The most important goal of data collection is to gather the information that is rich and accurate for statistical analysis.
- Direct staff and manage retrospective data collection to ensure Inpatient and Outpatient Core Measure data as assigned are appropriately maintained.
- Presented data collection plans at investigator meetings.
6. FDA
The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.
- Created statistical reports consisting of quantitative study data and worked closely with upper management, ensuring quality preparation for FDA submissions.
- Worked for contract research organization that streamlined data from major pharmaceutical companies in preparation for FDA review.
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Clinical operations caters to the administration of the drug development process by ensuring there is proper planning, appropriate conduct through the process, safety of patients and use of quality data. It also encompasses facilitating effective communication between the different study sites and sponsors of the drug process.
- Supervised daily clinical operations, regulatory compliance, quality improvement, in-service education, medical records.
- Collaborated with Myriad's Clinical Operations managers to oversee data discrepancy/reconciliation related to Serious Adverse Events across 3 studies.
8. Data Quality
- Instructed clinical members of the project team in ongoing data quality control.
- Major Accomplishments Drove 50% improvement in data quality by initiating new data cleaning process.
9. Data Review
Data review is an activity that verifies the correctness conditions of the data. This also includes specifying the type of error or unmet condition, as well as the data qualification and its division into error and error-free states.
- Performed raw data review and validation on discrepant data using the Data Validation Specifications.
- Write offline-listing specifications for data review, protocol violations, and lab-data reconciliation guidelines.
10. SAS
SAS stands for Statistical Analysis System which is a Statistical Software designed by SAS institute. This software enables users to perform advanced analytics and queries related to data analytics and predictive analysis. It can retrieve data from different sources and perform statistical analysis on it.
- Created SAS programs, and wrote statistical methods section of protocols and statistical reports.
- Trained data managers and SAS programmers on new processes.
11. Clinical Studies
- Collected, reviewed, and validated clinical trial and lab data generated in clinical studies and reported trending results.
- Gathered supporting scientific research material of upcoming clinical studies, analyzed and validated.
12. Direct Reports
- Communicated team/individual goals and expectations to ensure direct reports understand their responsibilities.
- Hire, train, coach, counsel and evaluate performance of direct reports and staff turnover
13. CDISC
- Generated, uploaded ASCII data transmission files according to specifications and worked with clients setting up CDISC and STDM files.
- Utilized technical experience managing clinical data using the CDISC SDTM standard to fulfill the role of the Metadata Analyst.
14. Clinical Trial Data
- Processed clinical trial data to ensure the integrity of the data used for inclusion in worldwide health registration.
- Coordinate the review and analysis of clinical trial data with authors, study sponsors and biostatisticians.
15. Data Entry
Data entry means entering data into a company's system with the help of a keyboard. A person responsible for entering data may also be asked to verify the authenticity of the data being entered. A person doing data entry must pay great attention to tiny details.
- Managed team of Clinical Data Managers and Data Entry Coordinators in support of all clinical study activities.
- Develop Case Report Forms (CRFs) in Frame Maker create DataFax data entry screens.
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List of clinical data management manager skills to add to your resume
The most important skills for a clinical data management manager resume and required skills for a clinical data management manager to have include:
- GCP
- Data Management
- Clinical Research
- CRO
- Data Collection
- FDA
- Clinical Operations
- Data Quality
- Data Review
- SAS
- Clinical Studies
- Direct Reports
- CDISC
- Clinical Trial Data
- Data Entry
- Electronic Data Capture
- Cdash
- CRF
- Clinical Trial Management
- Data Analysis
- Data Validation
- CRA
- User Acceptance
- Database Design
- UAT
- Biostatistics
- Management System
- QA
- Performance Reviews
- Process Improvement
- Macro
- QC
- Performance Metrics
- Edit Checks
- SAE
- Templates
- CTMS
- Status Reports
- Database Lock
- CDM
- Data Queries
- IVRS
- Oracle Clinical
- Phase III
- Project Issues
- OC
Updated January 8, 2025