Data Coordinator

Sun Pharmaceutical Industries, Inc.; Indiana (PA); Remote; USD 80,000 - 110,000; Full time

Job summary

A leading pharmaceutical company is seeking a Clinical Data Manager with a strong background in data management and documentation. This remote opportunity requires a pharmacy/science postgraduate with at least 5 years of experience in the Pharma/CRO industry. You will oversee the preparation of critical documents and manage discrepancies, ensuring data completeness and accuracy in clinical studies.

Qualifications

• At least 5 years of experience in clinical data management in Pharma/CRO industry.
• Experience in developing data management documents and validation plans.
• Strong skills in edit check UAT and clinical data query management.

Responsibilities

• Preparation & Review of start-up Documents.
• Ensure timely completion of SAE reconciliation activities.
• Support Data Manager in URS review for IWRS.

Skills

Data Management

Clinical Coding

Discrepancy Management

Validation Plan Development

Clinical Data Query Management

Education

Pharmacy / Science Post-Graduate

Job description

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Company: Sun Pharmaceutical Industries Ltd

YOUR TASKS AND RESPONSIBILITIES:

Preparation & Review of start-up Documents: eCRF completion Guidelines, DMP, SAE reconciliation plan, Clinical Coding Plan

Preparation of Edit specification document (ESD), Test Plan and Data Entry Guideline

Edit checks UAT in CDMS as per ESD

Discrepancy Management

Support Data Manager in URS review for IWRS

Ensure timely completion of SAE reconciliation activities

Ensure timely completion of closeout activities including database lock

Preparation and update of Master Data Management File to ensure its completeness

Preparation & Review of Data Management Report

WHO YOU ARE:

Pharmacy / Science Post-Graduate

At least 5 years of experience in the clinical data management domain in Pharma/CRO industry. Experience in, development of data management documents, development of validation plan, screen UAT, edit check UAT, clinical data query management etc.

Job Location: Remote working job opportunity