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Metro location and mid-level (5+) requirement increase competition, while niche CRO/pharma specialization moderates it.
Clinical trial and laboratory data processing skills are highly domain-specific and not easily transferable across industries.
Explicit 5+ years plus regulatory (ICH/GCP, 21 CFR) and CRO domain requirements make filtering stringent.
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.
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.
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.