Database Associate II | Mumbai, India
Company: Fortrea
Location: Mumbai, Maharashtra, India
Employment Type: Full-Time
Job ID: 26722
Application Deadline: 31 March 2026
About Fortrea
Fortrea is a leading global Contract Research Organization (CRO) delivering clinical development, data management, and regulatory solutions to pharmaceutical, biotechnology, and medical device companies. With strong expertise in Electronic Data Capture (EDC) systems and clinical database management, Fortrea supports sponsors in achieving high-quality, compliant, and timely clinical trial outcomes.
Position Overview
The Database Associate II provides technical clinical data management services across assigned clinical studies. This role focuses on Electronic Data Capture (EDC), Remote Data Capture (RDC), Oracle Clinical, and Bedside Data Capture systems to ensure accurate study build, validation, and on-time delivery of high-quality clinical trial data.
The position is ideal for professionals with experience in clinical database programming, study build design, edit checks, and EDC platforms within the pharmaceutical or CRO industry.
Key Responsibilities
Study Build and Database Design
Perform study build activities, including preparation of eCRF specifications and annotated data capture instruments.
Develop and design database screens in alignment with protocol requirements.
Participate in sponsor screen design review meetings, as required.
Create and document Edit Check Specifications.
Develop validation and derivation procedures based on protocol, eCRF, and edit check specifications.
Validation and Quality Control
Conduct quality control of study build activities, including:
eCRF specifications
Screen design
Validation checks
Edit check specifications
Create test scripts and test data to validate screen functionality and edit checks.
Perform peer review of test cases developed by team members.
Project Coordination and Communication
Participate in client meetings, study initiation visits, and study update meetings.
Provide regular project updates to the CDARO Project Manager and/or sponsor.
Communicate potential risks, issues, and study build progress in a timely manner.
Interact with IT teams regarding technical study build issues.
Training and Process Improvement
Provide training to clinical sites on screen design and data entry conventions, when required.
Support refinement and implementation of new data management processes.
Contribute to SOP development, validation standards, and best practices initiatives.
Assist in mentoring and training junior Clinical Operations and Data Management staff.
Operational Excellence
Prioritize tasks effectively to meet tight project timelines.
Maintain high standards of data integrity and compliance.
Demonstrate strong organizational skills and collaborative teamwork.
Educational Qualifications
Bachelor’s degree in Computer Science, Life Sciences, Pharmacy, or related field preferred
OR
Certification in an allied health profession (e.g., Nursing, Medical Technology, Laboratory Technology)
Equivalent relevant experience may be considered in lieu of formal education.
Experience Required
Minimum 1 year of clinical research experience in database maintenance, study build, or database programming.
Hands-on experience with Electronic Data Capture (EDC) systems or Oracle Clinical preferred.
Basic knowledge of SQL (Structured Query Language) preferred.
Understanding of clinical data management principles and clinical trial workflows.
Additional industry experience may substitute for educational requirements.
Key Skills and Competencies
Strong knowledge of clinical database design and validation processes.
Proficiency in EDC platforms and clinical data systems.
Good analytical and problem-solving skills.
Effective written and verbal communication skills.
Strong time management and ability to meet tight deadlines.
Team-oriented mindset with attention to detail.
Ability to manage multiple tasks simultaneously.
Work Environment
Office-based working conditions in Mumbai.
Extended computer usage (up to 8 hours per day).
Occasional overtime or weekend work may be required.
Potential travel for cross-site support, meetings, or training sessions.
Equal Opportunity Statement
Fortrea is committed to fostering a diverse and inclusive workplace. All qualified candidates will be considered in accordance with applicable employment laws and regulations.
Explore the latest Clinical Data Management, EDC Programming, Database Design, and CRO career opportunities at ThePharmaDaily.com.
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