Training and Compliance Specialist

July 31

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Clinical Trials Design • Planning • Safety Management • Custom Services • Study Management

201 - 500

Description

• Drive a culture of compliance within Clinical Research. • Evaluate the quality status of project deliverables by reviewing applicable project quality metrics and documentation and identifying and evaluating potential risks and quality issues. • Lead audit/inspection readiness activities including conducting routine/periodic quality assurance assessments. • Drive and manage an effective corrective action and preventive actions (CAPA) process. • Implement and update standardized metrics and other KPIs. • Work with project or functional teams to monitor lessons learned. • Lead the scheduled review of WIs and SOPs. • Review training compliance, highlight pending trainings, and support completion/file forms.

Requirements

• The successful candidate should hold either an undergrad degree with 4-6 years of relevant experience, or a college diploma with 7-9 years of relevant experience. • Health Sciences, Sciences or Clinical Research specialty preferred. • Excellent interpersonal, verbal and written communication skills. • Customer focused approach to work. • A flexible attitude with respect to work assignments and new learning. • Ability to manage and prioritize tasks efficiently and accurately. • Ability to work in a matrix environment and to value the importance of teamwork. • Ability to analyze and interpret data. • Attention to detail and organizational skills. • Ability to work independently and take ownership of and responsibility for work assigned. • IT literate. Experience with Microsoft based applications and a general knowledge of PC functions. • Culturally aware and ability to think and work globally.