External Data Reviewer

5 days ago

Bengaluru, India Fortrea - Organic Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Responsibilities/Duties:

- Ensure electronic lab data contains all protocol specified lab parameters, is in correct format and data populates to the specified fields and patients correctly.
- Review data discrepancies generated by study specific edit checks for laboratory data and assist in preparation of data clarification forms sent to the site or the central lab. Also, review missing/updated central laboratory data for potential request and substitution of local laboratory data.
- Perform 100% validation review of the electronically transmitted data for 5% of total number of patients in the study for loading purposes.
- Assist CDM Manager with review of laboratory edit checks, laboratory status reports and laboratory listings as necessary. Interact with Clinical staff (CTM/CRA) to obtain local laboratory normal ranges for all sites.
- Research and resolve discrepant information concerning the normal ranges, and maintain proper documentation. Enter and perform QC for local laboratory normal ranges.
- Verify the normal ranges are properly attached to the patient results in the local lab data collection module of the database.
- Perform other duties as required by the Department Responsible as contact person for the External source of electronic data transmissions.
- Keep the Central lab and client informed of problems involving data transfers, data point issues and validation issues.

Education/Qualifications:

- B.Sc/M.Sc Life Science or equivalent.

**Experience**:

- 3-5 years of relevant experience.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit


Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our

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