Job Title: Sr Clinical Data Specialist
Location: Bangalore
Category: Data Management & Data Science
Job ID: 2447289
Company Overview:
Fortrea is a leading global contract research organization (CRO), offering clinical development, patient access, and technology solutions across over 20 therapeutic areas. With operations in around 100 countries, Fortrea is focused on advancing drug and device development for clients and patients worldwide.
Job Overview:
As a Senior Clinical Data Specialist, you will primarily be responsible for clinical data review, query generation and resolution, and ensuring clinical data integrity in compliance with client specifications and project timelines. You will work closely with the team to ensure high-quality clinical data is delivered within agreed budgets and timelines, and may assist with project management duties such as creating data management plans or overseeing smaller project teams.
Key Responsibilities:
Clinical Data Review:
Review clinical trial data to identify erroneous, missing, or implausible data according to project Data Management Plans (DMP) and standardized processes.
Run diagnostic programs and generate listings to support the data review process.
Query Management:
Generate, resolve, and track queries for data discrepancies, working with the project team to ensure data quality.
Perform aggregate data review by patient, site, and project to identify trends or inconsistencies requiring further investigation.
Quality Control & Reporting:
Apply quality control procedures to ensure data quality standards are met, addressing any discrepancies promptly.
Assist in the development and testing of data management systems and validation checks.
Documentation & Planning:
Review and annotate CRFs (or eCRFs) and assist in the creation of data review guidelines to align with project requirements.
Support the development of project-specific data management plans and quality management plans.
Team Collaboration & Mentorship:
Mentor and coach project staff on global, standardized data management processes and project-specific requirements.
Serve as the operational leader for smaller projects, ensuring all data management activities are conducted according to client specifications and timelines.
Audit & Compliance:
Support internal or client audits, resolving any issues identified within the appropriate timeframe.
Qualifications:
Education:
A university or college degree in life sciences, health sciences, information technology, or related subjects. Equivalent experience may also be considered in lieu of a formal degree.
Experience:
4 to 6 years of clinical data management experience in a CRO or pharmaceutical setting.
Solid understanding of the clinical trial process and clinical data management systems.
Skills:
Strong organizational, time management, and communication skills.
Ability to work in a team environment and collaborate effectively.
Knowledge of medical terminology and scientific background is preferred.
Preferred Qualifications:
Experience:
At least 2 years of experience in Electronic Data Capture (EDC) systems.
Familiarity with Fortrea’s SOPs, data management tools, and organizational structure.
Work Environment:
This role offers both office and home-based work options.
Equal Opportunity Employer:
Fortrea is committed to fostering a diverse and inclusive workplace, ensuring that all employees are treated with dignity and respect. They do not tolerate discrimination or harassment of any kind.
This position offers an opportunity for an experienced clinical data professional to play a key role in managing high-quality clinical data and collaborating with a dynamic global team. If you're interested, feel free to apply or ask for more information!
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