Director, Clinical Compliance – Process and Procedural Documents

Summary:

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.)

 

Responsibilities:

• 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:

Requirements:

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