Offer summary

Qualifications:

Bachelor's degree in science or related field (1st-4th year students), Proficient in Microsoft Word, Excel, PowerPoint, and Outlook, Strong communication, teamwork, and organizational skills, Attention to detail and ability to work under pressure..

Key responsabilities:

Assist in database build and validation for clinical trial data

Help clean and standardize data, identifying errors or missing values

Participate in documentation and compliance activities following regulatory guidelines

Generate reports and summaries from trial data under supervision.

Job description

Overview

The Clinical Data Management Intern plays a supportive role in handling clinical trial data to ensure accuracy, consistency, and compliance with regulatory standards. All tasks performed by the intern will be under supervision.

Responsibilities:

Database build and Validation

Assist in configuration of electronic data capture (EDC) platform
Assist clinical data manager in creation of specifications
Assist clinical programmer in programming the platform
Validate data against specifications to identify inconsistencies.

Database Management & Cleaning

Help clean and standardize data by identifying errors or missing values.
Participate in data reconciliation between vendor database and EDC
Assist in documentation and review of specifications

Documentation & Compliance

Assist in preparing and maintaining study documentation following regulatory guidelines (e.g., FDA, ICH-GCP).

Query Management

Generate and resolve queries under supervision related to discrepancies in clinical data.
Review responses from sites and close queries

Reporting & Analysis

Assist in generating reports and summaries from trial data.
Learn to use data visualization tools (e.g. Spotfire)

Learning & Compliance Training

Participate in training sessions on clinical trial processes and CDM best practices.
Learn about different software used in clinical data management (e.g., Medidata Rave).

Education :

1st-4th-year students with a bachelor’s degree in science, or any related field of study
Able to work proactively.
Good interpersonal and communication skills, good teamwork skills.
Familiar with Microsoft Word, Excel, PowerPoint, Outlook.
Excellent written and verbal communication skills.
Works well under pressure and meets tight deadlines.
Fantastic organizational and time management skills.
Strong decision-making and critical thinking skills.
Meticulous attention to detail.

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