KEY TASKS & RESPONSIBILITIES
In addition to the duties outlined, performs additional duties and responsibilities based on developing skills and capabilities:
- Act as primary study contact, subject matter expert (SME) and liaison for external data and local lab processing on assigned studies for internal and external stakeholders.
- Communicate to Clinical Data Manager, study team, and/or Manager, External Data problems involving local lab data point issues and validation issues.
- Communicate to vendors and client issues involving external data transfers, 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 data

📌 Sr External Data Specialist (Bengaluru)
🏢 eClinical Solutions
📍 Bengaluru