Clin Data Coord I

3 days ago

Mumbai Maharashtra, India Fortrea 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.
- Ensure electronic vendor data contains all protocol specified parameters, is in correct format and data populates to the specified fields and patients correctly
- May support LDM in the development of the Data Transfer Agreement and Data Transfer Specifications for vendor data transfers.
- Review data discrepancies generated by study-specific edit checks for External data and perform the subsequent query management process in resolving the data issues.
- May support LDM to perform validation review of the electronically transmitted data for a sample of total number of patients in the study for loading purposes.
- Assist with review of External Data edit checks, External Data status reports and External Data listings.
- 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.
- May support LDM to communicate to vendors and client problems involving data transfers, data point issues and validation issues with initial oversite for support of this communication from EDS 2 or above

Qualifications (Minimum Required):
Experience (Minimum Required):

- 3 years prior experience in the pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.

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

Privacy Statement

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