Associate Eds Reviewer
hace 7 días
**Essential Job Duties**:
- Follow applicable departmental Standard Operating Procedures and Work Instructions.
- Complete required trainings according to timelines.
- Review and action queries on an ongoing basis and update database appropriately in accordance with Global Data Management Plans and applicable standardized data management.
- Perform UAT according to Validation Plan for applicable Data Management systems (if applicable).
Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data. Review reports and take actions as defined in the DMP or eCRF review manual. Assist with the review of clinical data by patient, site and / or project to identify data inconsistencies that require further investigation.
- Involve in data management system edit / data validation checks and special listings / procedures used as tools for the data review and discrepancy management activities.
- Maintain Data Management related operational data flows.
- Ensure that all Data Management activities are conducted in compliance with relevant regulatory requirements.
- Other duties as assigned by study management
**Requirements**:
- Fluent in English, both written and verbal.
- 2 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.
**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
For more information about how we collect and store your personal data, please see our Privacy Statement.
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