Clinical Data Manager

SUN PHARMA; Piemonte; In loco; EUR 35.000 - 60.000; Tempo pieno

Descrizione del lavoro

LB Research srl - Clinical Trials Management (Part of 1MED) in Cantù, Lombardy, Italy is seeking a Clinical Data Manager with 1-3 years of experience to join our Data Management Unit. The role focuses on ensuring accuracy, consistency, and integrity of clinical trial data across all phases.

You will oversee database design, CRF/eCRF layouts, data entry, data cleaning, and database lock, collaborating with Project Managers, Statisticians, and Sponsors to deliver clean datasets for analysis.

Competenze

• 1–3 years of experience in Clinical Data Management.
• Experience with eCRF-based studies.
• Bachelor's degree in Life Sciences, Statistics, Health Sciences, or related field (preferred).

Mansioni

• Design databases and CRF/eCRF layouts.
• Prepare Data Management Plan (DMP) and Edit Check Plan with Study PM.
• Oversee data entry and data cleaning per plan.
• Conduct database lock activities and transfer data for analysis.

Conoscenze

Clinical Data Management

GCP knowledge

SQL

SAS

Formazione

Bachelor's degree in Life Sciences, Statistics, Health Sciences, or related field

Strumenti

EDC systems

eCRF platforms

Descrizione del lavoro

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LB Research is a Contract Research Organization (CRO) founded in 2007, providing comprehensive clinical research services to both local and multinational pharmaceutical companies. We support the management of a wide range of clinical studies, including interventional and observational trials, as well as studies involving medical devices and food supplements. Our team works closely with Sponsors throughout the entire project lifecycle, from study start-up and contract finalization to database lock, statistical analysis, and final results delivery.

Clinical Data Manager

Job Overview

We are looking for a Clinical Data Manager with 1-3 years of experience to join our Data Management Unit. The Clinical Data Manager will be involved in all phases of the Data Management process, ensuring the accuracy, consistency, and integrity of clinical trial data. The role includes oversight of database design, data entry, data cleaning activities, and database lock procedures, while collaborating closely with Project Managers, Statisticians, and Sponsors.

Key Responsibilities

The Clinical Data Manager will be responsible for:

Database and eCRF Design:

• Defining the database structure and layout for paper CRFs and electronic CRFs (eCRFs).
• Reviewing and verifying CRF/eCRF layouts.
• Defining and implementing eCRF and database validation checks, where applicable.
• Creating and maintaining annotated CRFs.

Data Management Planning:

• Preparing and updating the Data Management Plan (DMP) in collaboration with the Study Project Manager.
• Preparing and maintaining the Edit Check Plan for both paper CRF and eCRF studies.

Data Processing and Quality Control:

• Supervising data entry activities and ensuring the accuracy of data entered into the database.
• Performing or overseeing database reconciliation activities, including double data entry reconciliation when applicable.
• Performing or supervising data cleaning activities according to the Edit Check Plan.
• Identifying, investigating, and resolving data discrepancies to ensure data quality and compliance.

Database Review and Lock:

• Preparing Data Management documentation and participating in review meetings.
• Conducting database lock activities according to study procedures.
• Exporting and transferring final databases to the Statistician and/or Sponsor for statistical analysis.

Qualifications and Experience

• Bachelor's degree in Life Sciences, Statistics, Health Sciences, or a related field (preferred).
• 1-3 years of experience in Clinical Data Management within the pharmaceutical, biotechnology, CRO, or clinical research environment.
• Experience with eCRF-based studies.

Knowledge and Technical Skills

• Good knowledge of clinical research processes and Clinical Data Management principles.
• Good knowledge of Good Clinical Practice (GCP) guidelines and data integrity principles.
• Good knowledge of SQL and SAS.
• Familiarity with clinical databases and Electronic Data Capture (EDC) systems.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

Industries

• Pharmaceutical Manufacturing

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