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Our Clinical Operations/Compliance Consultants support our clients with both the Trial Master Files Services and Consulting units, acting as a Clinical Operations Process Optimization SME. A passion for driving compliant change is a key requirement. To be considered, applicants must have several years experience in managing clinical trials within a sponsor or CRO environment. This is not a site opportunity.

Job Duties:

• Develop, apply, and align best practice standards for processes based on an understanding of Clinical Operations, industry regulations and guidance
• Support innovation and the delivery of continuous process improvement across the organization
• Participate in projects and initiatives across clients
• Act as Consultant and SME in supporting projects related to Clinical Operations, TMF Remediation & Health Authority Inspections
• Drive process analysis and optimization, leveraging best practices
• Assess client business needs to identify process gaps and non-compliance
• Remain current on Health Authority expectations related to clinical trial activities
• Participate in and lead (where appropriate) meetings: internal meetings, project meetings, and client meetings
• Ensure all work activities are performed in compliance with requirements of Good Clinical Practice

Qualifications

• Minimum 8 years experience in trial management or clinical compliance in sponsor or CRO enviornment
• Minimum 3 years experience in TMF activities
• Experience with multiple clinical systems including TMF and CTMS
• Ability to align best practice with customer needs
• Working knowledge of international regulatory requirements and ethics requirements
• Ability to lead small teams
• Knowledge of drug development process
• Change management experience, either having led or supported change management programs
• Critical thinking skills with strong problem-solving skills
• Bachelors Degree