Compliance and Training Specialist

3 weeks ago

Winnipeg, Manitoba, Canada Alimentiv Full time
Job Title: Training & Compliance Specialist

At Alimentiv, we are seeking a highly skilled Training & Compliance Specialist to join our team. This role is responsible for driving a culture of compliance within Clinical Research, ensuring that our projects meet the highest standards of quality and regulatory requirements.

Key Responsibilities:
  • Lead audit/inspection readiness activities, including conducting routine/periodic quality assurance assessments to measure and ensure adherence of departmental processes and procedures.
  • Support the conduct of inspections and audits, collaborating closely with the Global QA department to prepare for internal audits and regulatory inspections.
  • Analyze audit and inspection findings, suggesting remediation and maintaining an overview of CAPA responses and resulting measures.
  • Drive and manage an effective corrective action and preventive actions (CAPA) process, including tracking, trend analysis, root cause analysis, and implementation of process improvement measures.
  • Implement and update standardized metrics and other Key Performance Indicators (KPIs), working with study teams to track desired metrics and KPIs.
  • Monitor metrics across studies, provide trend reports, and work with relevant partners to identify potential areas for process improvements.
  • Work with project or functional teams to monitor lessons learned, ensuring any gaps highlighted through learnings are addressed through training or process development.
  • Lead the scheduled review of WIs and SOPs, developing new SOPs and WIs as required, and supporting the identification of gaps in current procedures.
  • Develop or oversee the development of templates and tools to support the implementation of SOPs and WIs.
  • Review training compliance, highlighting pending trainings, and support completion/file forms 239.
  • Proactively work to identify unmet training needs, supporting the creation of a departmental training curriculum.
  • Lead the creation of training materials and training implementation, ensuring a common understanding around processes.
Qualifications:
  • A bachelor's 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.
  • A 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 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, with experience with Microsoft-based applications and a general knowledge of PC functions.
  • Culturally aware and able to think and work globally.

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