Clinical Data Manager
10+ Clinical Data Manager Interview Questions and Answers
Q1. How to generate queries in Rave database ?
Queries in Rave database can be generated using the query tool within the system.
Access the query tool within the Rave database system.
Select the form and field for which you want to generate a query.
Define the query criteria and save it within the system.
Review and address any generated queries to ensure data accuracy.
Close the query once the issue is resolved.
Q2. Drug name of antibiotics? Drug of diabetes? Drug of hypertension? Explain DM? What is hypertension?
Antibiotics are drugs used to treat bacterial infections. Diabetes drugs help manage blood sugar levels. Hypertension drugs control high blood pressure. DM stands for Diabetes Mellitus. Hypertension is high blood pressure.
Antibiotics are used to treat bacterial infections, such as amoxicillin and azithromycin.
Diabetes drugs help manage blood sugar levels, such as metformin and insulin.
Hypertension drugs control high blood pressure, such as lisinopril and losartan.
DM stands fo...read more
Clinical Data Manager Interview Questions and Answers for Freshers
Q3. What is CRF ?what are the quirys
CRF stands for Case Report Form. It is a document used in clinical trials to record data from each participant.
CRF is a standardized form designed to collect specific data points for each participant in a clinical trial
It includes information such as demographics, medical history, treatment received, and any adverse events
Queries are questions or clarifications raised by data managers or monitors regarding the information recorded on the CRF
Queries are used to ensure accuracy...read more
Q4. SAE reconciliation and it's repercussions
SAE reconciliation involves comparing serious adverse events reported in clinical trials with data from other sources to ensure accuracy and completeness.
SAE reconciliation is a crucial step in clinical data management to ensure patient safety and data integrity.
It involves comparing SAE data reported in clinical trial databases with information from other sources such as medical records or safety databases.
Reconciliation discrepancies may lead to protocol deviations, delays ...read more
Q5. What are database changes?
Database changes refer to modifications made to the structure or content of a database.
Database changes can include adding, modifying, or deleting tables, columns, or records.
Changes can also involve updating data values, enforcing constraints, or creating indexes.
Examples of database changes include adding a new field to a table, deleting a record, or altering a column's data type.
Q6. compare large CRO and small CRO companies
Large CROs have more resources and global reach, while small CROs offer more personalized service and flexibility.
Large CROs typically have more resources for conducting large-scale clinical trials
Small CROs may offer more personalized service and flexibility in adapting to client needs
Large CROs often have a global reach with offices in multiple countries
Small CROs may have a more focused expertise in specific therapeutic areas
Large CROs may have established relationships wi...read more
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Q7. Why clinical data management?
Clinical data management allows for accurate collection, organization, and analysis of data to ensure quality and integrity in clinical trials.
Ensures data accuracy and integrity in clinical trials
Organizes and manages large volumes of data efficiently
Facilitates compliance with regulatory requirements
Supports decision-making processes based on reliable data
Contributes to the overall success of clinical research studies
Q8. What is sae reconciliation
SAE reconciliation is the process of comparing and resolving discrepancies between different sources of serious adverse event data.
SAE reconciliation involves comparing data from different sources, such as case report forms and safety databases.
The goal is to identify and resolve any discrepancies or inconsistencies in the reported serious adverse events.
This process ensures data accuracy and integrity in clinical trials and helps in generating reliable safety reports.
Example...read more
Clinical Data Manager Jobs
Q9. Conduct phase activities in CDM
Phase activities in CDM involve data collection, cleaning, validation, and analysis to ensure accuracy and integrity of clinical trial data.
Data collection: Gather information from various sources such as case report forms, electronic health records, and laboratory reports.
Data cleaning: Identify and resolve discrepancies, errors, and missing data to ensure data quality.
Data validation: Perform quality checks to ensure data accuracy and consistency.
Data analysis: Analyze the ...read more
Q10. What is you core value
My core value is integrity, as I believe in always being honest, ethical, and transparent in my work.
Honesty and transparency in all data management processes
Adherence to ethical guidelines and regulations
Maintaining confidentiality and privacy of patient information
Ensuring accuracy and reliability of clinical data
Building trust with colleagues and stakeholders
Q11. End to end CDM activities
End to end CDM activities involve managing clinical trial data from start to finish.
Designing data collection forms
Data entry and validation
Database lock and analysis
Ensuring data quality and integrity
Adhering to regulatory requirements
Collaborating with cross-functional teams
Q12. Local Lab experience
I have experience working with local labs to ensure accurate and timely data collection.
Coordinated with local labs to establish data transfer protocols
Reviewed lab data for completeness and accuracy
Communicated with study team to address any discrepancies or issues
Ensured compliance with regulatory requirements
Trained local lab staff on study-specific procedures
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