Clinical Data Management Operations Analyst

Gaithersburg, MD 20878

Posted: 11/14/2018 Industry: Other Area(s) Job Number: 32513

Clinical Data Management Operations Analyst

 

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.

 

 

Requirements/Qualifications:

Education:

•             Education: Minimum of a BS in life sciences degree and/or equivalent 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 •            Strong understanding of clinical trial methodology, GCP, ICH and medical terminology

•             Experience with major EDC platforms such as Medidata Rave

•             Competent project management skills

•             Excellent communication and interpersonal skills

•             Knowledge of issues surrounding CDM activities related to clinical trials data

•             Ability to work independently, under pressure meeting tight deadlines, demonstrating high level of initiative and flexibility.

•             Excellent organizational and analytical skills

•             High attention to detail and accuracy

•             Proven problem and conflict solving skills

•             Demonstrated knowledge of clinical and pharmaceutical drug development process

•             Demonstrated understanding of Good Clinical Practices (GCP), Good Clinical Data Management Practices (GCDMP), and regulatory requirements as they relate to data management systems and activities

•             Experience with clinical databases, clinical data management systems and electronic data capture (EDC)

•             Demonstrated ability to work effectively with internal groups, external partners, and in a global team environment
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