External Data Specialist
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The External Data Specialist is responsible for the processing of external and/or local lab data received at eClinical Solutions throughout the clinical trial lifecycle. The External Data Specialist works to ensure departmental SOPs, guidelines, and global standards are followed to maintain data integrity and ensure consistency across all assigned projects.
Your day to day:
In addition to the duties outlined, performs additional duties and responsibilities based on developing skills and capabilities:
- Communicate to Clinical Data Manager, study team, and/or Manager, External Data problems involving local lab and/or vendor data point issues and validation issues
- Perform QC of laboratory normal ranges prior to entry to ensure documents received are ICH/CGP compliant and accurate
- Perform Lab Normal Range data entry and/or QC, meeting processing deliverables on time and with quality
- Review study protocols and local lab and external data eCRF design in start-up, providing recommendations and insights into best approach for data aggregation and capture
- Ensure clinical database supports data requirements and is in alignment with external vendor data
- Perform QC of external data test transfers for acceptance
- Maintain external data reconciliation logs and/or change logs
- Verify the normal ranges are properly linked to the patient results in the local lab data collection module of the database
- Review external vendor data and/or local laboratory data listings via elluminate® and issue queries or communicate data issues to internal and/or external team members
- Review and provide input to DMP, IDROP, and CCG to ensure local lab normal range and/or external data process for assigned study is accurately documented
- Perform local lab and external vendor associated study start-up and build activities
- Perform IST activities for local lab normal range population
- Develop the local lab and external data exception listing specifications and associated visualizations, and QC the output for movement to production
- Provide support for set-up and implementation of external vendor data transfer agreements
- Provide study-specific local lab and/or external vendor data-driven metrics to Clinical Data Management, Client, and/or Project Management
- Attend internal and external study team calls, as needed, for support of study-specific local lab and external vendor data processes
- Work closely with cross-functional teams on study reporting and data trending via clinical data analytics technologies for local laboratory and/or external vendor data to proactively identify and mitigate risks
- Support Manager, External Data with Lab Admin team mentoring
- Other duties as assigned
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eClinical Solutions
View Company ProfileeClinical Solutions (operating at eclinicalsol.com) is a clinical data management solutions platform engineered for biopharma researchers. Founded in 2012 by Bob Arnesen and Raj Indupuri, and headquartered in Mansfield, MA, eClinical Solutions makes clinical research data acquisition and analysis easy and intelligent to help bring new treatments to patients faster. Under the hood, the company's industry-leading data & analytics platform, elluminate, and biometrics services experts help biopharma researchers. This allows biopharma researchers to acquire and analyze clinical research data more efficiently. Backed by a growth investment by GI Partners.
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