Senior Clinical Data Coordinator

Senior Clinical Data Coordinator Interview Questions and Answers

Updated 26 Jun 2024

Q1. CDM activities handled or done previously with brief

Ans.

Managed various clinical data management activities including data cleaning, database lock, and query resolution.

  • Performed data cleaning to ensure accuracy and consistency of clinical trial data

  • Managed database lock activities to prevent further data entry or changes

  • Resolved queries from clinical sites and investigators to ensure data integrity

  • Worked closely with cross-functional teams to ensure timely and accurate data management

  • Utilized data management tools such as Medidat...read more

Q2. Documents involved in trial setups

Ans.

Documents involved in trial setups include protocol, informed consent forms, case report forms, and investigator's brochure.

  • Protocol outlines the objectives, design, methodology, statistical considerations, and organization of a clinical trial.

  • Informed consent forms provide information about the study to participants and ensure their voluntary participation.

  • Case report forms are used to collect data on each participant in the trial.

  • Investigator's brochure contains information...read more

Q3. Activities of setup and conduct

Ans.

Activities of setup and conduct involve planning and executing clinical trials to collect and analyze data.

  • Setup activities include protocol development, database setup, and training staff.

  • Conduct activities involve patient recruitment, data collection, monitoring, and reporting.

  • Ensuring compliance with regulatory requirements and maintaining data quality are key responsibilities.

Q4. What are the study milestones

Ans.

Study milestones are key events or time points in a clinical trial that mark progress and help ensure the study stays on track.

  • Study initiation: Setting up the study protocol, obtaining necessary approvals, and recruiting participants.

  • First patient enrolled: Marks the beginning of data collection and analysis.

  • Interim analysis: Assessing the data at a pre-specified time point to ensure safety and efficacy.

  • Last patient visit: Marks the end of data collection.

  • Database lock: Fina...read more

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