Clinical Data Analyst

1 - 5 years

0 Lacs

Posted:1 day ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: You will be responsible for creating, maintaining, and updating study-specific documents such as Data Management Plan, Data Validation Plan, study-specific procedures, and data reconciliation plan. Additionally, you will design Case Report Forms for paper and EDC studies, perform data entry in the database, coordinate with other study team members for data management tasks, and ensure data integrity by creating and testing UAT data in the study database. Key Responsibilities: - Train clinical sites on using the study-specific database for EDC studies - Identify and resolve data discrepancies through computerized and manual checks - Perform Quality Review of live data and apply level 1 corrections to the database - Generate queries, update and verify received DCFs and Ex-DCFs - Handle external data, perform external data reconciliation, and resolve related queries - Reconcile Serious Adverse Events (SAE) and resolve SAE queries - Perform Medical Coding of terms reported on Case Report Form - Adhere to Standard Operating Procedures, work procedures, and project scope to ensure quality - Maintain documentation of training and collaborate with other project team members such as the External team, Programmer, Statistician, Monitor, and CRA - Conform to the training schedule, maintain awareness of SOP content in the Data Management team, and comply with company requirements Qualifications Required: - Master's degree preferred - Minimum of 1 year of total work experience required Company Details: No additional details of the company were mentioned in the job description. Note: This is a full-time, permanent position located in Ahmedabad. Health insurance and Provident Fund benefits are provided. Applicants are required to answer specific application questions regarding relocation to Ahmedabad and previous experience in Clinical Data Management. The work location is in person.,

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