External Data Reviewer
hace 1 día
Essential Job Duties:
- 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.
- Perform other duties as required by the Department.
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.
- Basic understanding of medical terminology a plus.
- Strong organizational, planning, and critical-thinking skills.
- Well-polished, inclusive, and engaging communication skills (written and verbal) to support effective interactions with sponsors and internal colleagues.
- Ability to handle multiple tasks in a timely and professional manner under demanding conditions.
- Ability to use standard Microsoft suite of software products.
- Strong technical aptitude.
- Ability to maintain confidentiality of data and information during interaction with staff at all levels.
- Understanding of ICH-GCP principles.
- Fluent in English, both written and verbal
**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp 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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