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Clinical data associate skills for your resume and career
15 clinical data associate skills for your resume and career
1. 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.
- Generate and use ancillary reports (data listings, reconciliation discrepancy listings, query listings) for clinical data review.
- Review Clinical Trial data in accordance with data review conventions to identify erroneous, missing, incomplete or implausible data.
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.
- Reconcile project files and other documents generated in data management against a database for accuracy and completeness of data management processes.
- Contributed to several Data Management infrastructure projects, including the development of departmental data preparation for study approval submissions.
3. 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.
- Make sure they are following IRB and FDA Guidelines.
- Perform database finalization for various abstract and FDA submissions.
4. 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.
- Performed review of discrepancy (edit checks) output and SAS listings based on data entered into Clinical EDC database.
- Ensured rapid identification of database errors by writing SAS code to validate clinical data.
5. Clinical Trial Data
- Reviewed and processed clinical trial data to ensure the accuracy and consistency of clinical databases.
- Reviewed clinical trial data and maintenance of clinical databases.
6. Data Quality
- Scanned and controlled data quality in clinical trials management database.
- Prepared data quality checks and edit specifications.
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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.
- Establish study protocols and guidelines for administration and data collection procedures.
- Reviewed all protocol-related study documents to ensure that data collection.
8. UAT
UAT stands for user acceptance testing, and it is the last phase in the software testing process that determines whether the software is fit for the purpose it was built or not. UAT checks two main things; whether the software fulfills the business requirements and can it be used by the end-users. It is the final and most critical step in the testing stages and it determines whether the software should be introduced in the market or not.
- Review and approve IxRS specs and perform UAT.
- Performed User Acceptance Testing (UAT) on validation checks including input to and review of edit checks.
9. 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.
- Work with the internal study team and/or CRO on assigned studies to identify data issues and proactively address data issues.
- Created job description for Liaison with CRO to initiate confidentiality agreements and consulting agreements.
10. Data Validation
Data validation is the process of reviewing and arranging data for efficient data analysis. Data validation includes checking data accuracy, quality of data source, and identifying the importance or relevance of the data.
- Review Data Validation and Data Cleaning Specifications including Lab and SAE reconciliation plan.
- Provided an understanding of project protocol and Data Validation Manual.
11. Edit Checks
- Assist in writing edit check documents, create test patients and perform validation of edit checks.
- Created edit checks creation and tested for study start-up using both EDC and OC.
12. Electronic Data Capture
Electronic data capture is the process of gathering data using special computer programs and systems.
- Communicate with electronic data capture vendor to ensure appropriate forms maintained in study database and removal of inappropriate forms.
- Performed regular data entry using Oracle Clinical and Electronic Data Capture Databases.
13. QC
Quality control is a set of instructions or procedures to ensure a manufactured product or a service is up to the highest quality standards. This set of quality control criteria are either defined by the clients or the company itself.
- Administered the execution of QC evaluation for data entered into the CTMS that led to senior management exceeding client deliverable expectations.
- Performed internal QC audits of the clinical database against the paper data including query results.
14. Completion Guidelines
- Participated in the development of completion guidelines and CRF design.
- Developed work instructions, CRFs, CRF completion guidelines and other related documentation.
15. Study Timelines
- Communicated with sponsors/study teams regularly to provide a status update, address any issues and discuss projected study timelines.
- Assist in developing and maintaining recruitment plan to ensure enrollment against study timelines.
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List of clinical data associate skills to add to your resume
The most important skills for a clinical data associate resume and required skills for a clinical data associate to have include:
- Data Review
- Data Management
- FDA
- SAS
- Clinical Trial Data
- Data Quality
- Data Collection
- UAT
- CRO
- Data Validation
- Edit Checks
- Electronic Data Capture
- QC
- Completion Guidelines
- Study Timelines
- User Acceptance
- Clinical Data Entry
- Regulatory Guidelines
- CDA
- Database Lock
- Query Resolution
- Management Plans
- CDM
- Quality Expectations
- Pharmaceutical Industry
- Rave
- DCFS
- CRA
- Update Data
- Query Management
- Database Design
- Test Data
- Clinical Study Data
- Oracle Clinical
- Manual Review
- Data Queries
- GCP
- DMP
- CRFs
- Ecrf
- Data Entry Screens
- Discrepancy Management
- RDC
- Computer Software
- ECG
- Phase III
- Internal Audit
- OC
Updated January 8, 2025