Sr External Data Specialist
eClinical Solutions (company site, opens in a new tab)5+ yrsBengaluruOn-siteDirect career pageEst. 10–16 LPA
Posted on 3 Sept
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Job description
Structured overview of role & requirements
About This Role
- Manage processing and quality control of various external and local lab data across clinical trial lifecycle.
- Act as subject matter expert and primary contact for external data and local lab processing issues for internal teams, vendors, and clients.
- Ensure compliance with SOPs, regulatory guidelines, and data integrity; support study start-up, data transfer agreements, metrics reporting, and process improvements.
Minimum Requirements
- Bachelor of Science or equivalent in health-related field, Medical Laboratory Technology certificate preferred.
- 5+ years of relevant experience in external data handling or clinical data management within CRO or pharmaceutical industry.
- Strong knowledge of ICH/GCP, 21 CFR Part 11, clinical trial methodology and medical terminology.
- Proficiency with clinical data management systems, electronic data capture, and Microsoft Office; strong data confidentiality and communication skills.
Ideal Candidate Profile
- Experienced in managing multiple clinical trial external data streams including labs, imaging, PK/PD, eCOA/ePRO with cross-functional coordination.
- Demonstrates leadership and mentoring capabilities; able to independently handle complex data issues and vendor relationships.
- Comfortable driving process improvements and adopting digital transformation technologies such as AI/ML and advanced analytics for data monitoring.