Clinical Data Coordinator I

1 month ago

Mumbai, 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.

May support LDM with the review, maintenance and update of External Vendor data received from central vendor or local laboratories. Working to ensure department SOPs, guidelines and global standards are followed to maintain data integrity and ensure consistency across all projects. 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. 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 purpose. Assist with the 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 maintaining proper documentation. Enter and perform QC for local laboratory normal ranges. Verify the 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 validaton issues with initial oversite for support of this communication from EDS 2 or above. Perform other duties as required by the department. Bachelors degree or equivalent in lifescience. 2 - 4 Years of experience into similar role.

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.

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