Job Title: Database Associate II
Company: Fortrea
Location: Mumbai, India
Department: Data Management & Data Science
Job Type: Full-Time
Job ID: 26722
Experience Required: Minimum 1 Year of Clinical Research or Clinical Data Management Experience
About Fortrea
Fortrea is a global contract research organization (CRO) specializing in clinical development, data management, and pharmacovigilance services for pharmaceutical, biotechnology, and medical device companies. With extensive expertise in clinical trial management and advanced data solutions, Fortrea supports sponsors across the entire drug development lifecycle while ensuring data accuracy, regulatory compliance, and operational efficiency.
Role Overview
The Database Associate II is responsible for providing technical support for clinical trial data management systems including Electronic Data Capture (EDC), Remote Data Capture (RDC), Oracle Clinical, and Bedside Data Capture platforms. This role contributes to the design, development, validation, and maintenance of clinical study databases to ensure accurate and timely data collection for clinical trials.
The position requires strong technical and analytical skills to support study database builds, validation procedures, and data quality checks while ensuring compliance with regulatory standards and clinical research best practices.
Key Responsibilities
Clinical Database Design and Study Build
Support the design and development of clinical study databases.
Prepare eCRF (Electronic Case Report Form) specifications or annotated data capture instruments.
Participate in screen design development and database configuration activities.
Edit Check and Validation Development
Develop edit check specifications to ensure data accuracy and consistency.
Write validation and derivation procedures based on the protocol, eCRF specifications, and data capture instruments.
Ensure validation rules are aligned with study requirements and regulatory standards.
Quality Control and Testing
Conduct quality control checks for study build and database design components including eCRF specifications, screen design, and validation checks.
Develop test data and scripts to validate screen designs and edit check logic.
Perform peer review of testing scenarios and validation procedures prepared by other team members.
Project Coordination and Client Interaction
Participate in client meetings, study initiation visits, and study update discussions when required.
Provide regular project updates to the Clinical Data Management Project Manager and stakeholders regarding project progress and potential risks.
Clinical Site Support and Training
Provide training to clinical site staff on screen design usage and data entry procedures.
Support users with database-related queries during clinical trial execution.
Process Improvement and Compliance
Follow and implement standard operating procedures (SOPs) related to clinical data management processes.
Participate in the development and improvement of SOPs, validation standards, and operational workflows.
Contribute to continuous process improvement initiatives within clinical data management teams.
Cross-Functional Collaboration
Work with IT teams to resolve database design and system-related issues.
Support internal teams involved in clinical operations and data management activities.
Educational Qualifications
Bachelor’s degree in Computer Science, Life Sciences, Pharmacy, or a related discipline.
Certification in allied health professions such as nursing, laboratory technology, or medical technology may also be considered.
Experience Requirements
Minimum 1 year of experience in clinical research or clinical data management.
Experience working with clinical databases and study build processes is preferred.
Required Skills and Competencies
Strong understanding of clinical data management concepts and processes.
Knowledge of Electronic Data Capture (EDC) systems or Oracle Clinical databases.
Basic knowledge of SQL (Structured Query Language) is preferred.
Strong attention to detail and analytical thinking abilities.
Effective communication and teamwork skills.
Ability to manage multiple tasks and work within tight project timelines.
Technical Skills
Experience with clinical database platforms such as EDC or Oracle Clinical.
Proficiency in Microsoft Office tools including Excel, Word, and PowerPoint.
Familiarity with database testing, validation, and edit check development.
Work Environment
This position operates in an office-based environment and requires extended computer usage for database design and testing activities. Occasional overtime or weekend work may be required depending on project timelines. Limited travel may be required for cross-site support, meetings, or training.
Job Location
Mumbai, India.
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