eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. OVERVIEW The Senior External Data Specialist is responsible for managing the processing of external and/or local lab data received at eClinical Solutions throughout the clinical trial lifecycle. The Senior External Data Specialist will provide subject matter expertise in external data handling of various external data sources (ie: central laboratories, imaging, PK, PD, eCOA, ePRO, etc.) to internal cross-functional teams and external stakeholders to ensure high quality data. The Senior External Data Specialist works to ensure departmental SOPs, guidelines, regulatory and global standards are followed to maintain data integrity and ensure consistency across all assigned projects. This position reports to the Manager, External Data. 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 a
Role overview
Job description
eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate , throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively mana
…What they are looking for
Skills & requirements
Qualification
Bachelor’s degree in Pharmaceutical/Biotechnology or higher in health-related field preferred 8+ years in Clinical Data Management experience preferred Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology Strong project management experience and project team leadership skills including work planning and work delegation Experience with EDC and performing data management activities Excellent verbal and written communication skills Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel Experience with EDC and Clinical Data Management Systems Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical is a winner of the 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. See all the details here: https://topworkplaces.com/company/eclinical-solutions/ eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our bu
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Hiring company
eClinical Solutions
Наша компания имеет большой опыт внедрения и кастомизации таких систем как OpenClinica, ClinCapture и других. На основании накопленного опыта мы разработали уникальную систему EDC / eCRF, впитавшую в себя лучшее из других систем.
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