Responsible for oversight of the core processes within clinical development, including implementation of a process improvement methodology. This position also oversees the writing through the approval stage of all controlled procedural documents (SOPs, Work Instructions, Forms, etc.)
• Along with the head of Clinical Compliance, establish a process improvement culture
• Regularly perform gap analysis assessments for core Clinical Development and Regulatory Affairs processes and procedures. Ensure that the identified gaps are addressed through process improvement.
• Develop and assess SOPs, Working Practices and Forms that are easily followed in order to ensure they adequately reflect best work practices and comply with regulatory guidelines
• Develop a methodology for monitoring compliance to procedural documents by internal staff and external Sites and partners.
• Build a comprehensive set of metrics to monitor the effectiveness of the core clinical processes on an ongoing basis.
• Responsible for leveraging the technology already in place and for ensuring that any new technology adequately supports the ongoing business process.
• Provide management oversight to members of staff within the procedural document function.
• Support Regulatory Inspections as needed
Experience and Required Skills:
Bachelor’s degree (Advanced degree preferred) with 10+ years relevant industry experience.
• Bachelors or Master’s degree with at least 10 years of relevant industry experience
• Extensive experience and knowledge in the development of procedural documents
• Demonstrated knowledge of clinical processes including GCP Regulations.
• Skilled in Process Improvement Methodology.
• Demonstrated experience leading process improvement initiatives.
• Excellent communication skills and ability to work with people in all levels of the organization.
• Demonstrated skills in taking initiative and working independently