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Clinical Data Manager - Snr Analyst

Bethesda Metro Area, MD

Posted: 11/14/2018 Job Type: Clinical Job Number: JN -112018-23051
Education:
Education: Minimum of a BS in life sciences degree and/or equivalent experience
Experience:
Minimum of 5 years of Study Data Manager experience in the Biotech/Pharma/CRO industry
Experience as a project manager of special initiatives supporting CDM activities.
Experience in CDM process development
Strong problem-solving skills with CDM process and experience on computer systems for Data Management.
Strong understanding of clinical trial methodology, GCP, ICH and medical terminology
Experience with major EDC platforms such as Medidata Rave
Overview:
CDM Business Operations Senior Analyst within Clinical Data Management
This position has focus upon activities and objectives that measure the internal quality and performance metrics as well as the external vendor (CRO) KPIs. In addition, as part of continuous improvement this position is responsible for assessing quality gaps and CAPA submissions, identifying isolated events from systemic issues and delivering improved process mitigation strategies and trainings. As a broader corporate initiative this role supports CDM s TMF/eTMF processes, currency, and compliance tracking for audit readiness. The role manages and maintains initiatives and actions regarding quality standards, process development, resource training, and performance metrics.
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