Director, Clinical Operational Excellence

Role Summary

Director of Clinical Operational Excellence will lead strategic initiatives that optimize and standardize clinical operations across global programs. This role drives continuous improvement, ensures regulatory compliance, and fosters a culture of quality and efficiency. The Director will design and implement process improvements, oversee training and SOP management, and apply data-driven insights to enhance clinical trial execution.

Responsibilities

• Develop, lead and implement process optimization strategies for clinical operations to enhance efficiency, reduce costs, and ensure regulatory compliance through strategic leadership, process management and change enablement.
• Lead Clinical Operations strategic planning sessions to align process improvement goals with long-term business objectives.
• Establish mechanisms to identify, prioritize and resolve process issues/gaps within Clinical Operations; prioritize and implement process improvements through collaborative problem solving and effective communication.
• Identify opportunities for improvement within existing operational processes and lead continuous improvement programs, applying methodologies such as Lean Six Sigma to drive measurable outcomes.
• Track and report performance metrics to demonstrate impact of improvements.
• Lead the production and reporting of operational excellence metrics to the Clinical Operations Leadership Team and key internal stakeholders, driving decisions based on data and analysis.
• Ensure GCP compliance and data integrity through data-driven insights.
• Oversee creation, maintenance and obsolescence of Clinical SOP/WI/Forms/Templates; direct work related to new process creation, training and rollout.
• Manage QMS CAPAs, Deviations, and Document Change Controls (DCCs); support and manage audit findings and resolutions.
• Monitor Clinical Operations training compliance; manage processes for ensuring that clinical operations and related CSPs using ACADIA processes are current with training and training documentation; may conduct training for small groups and participate in training sessions for CSPs
• Manage the Clinical Operations Training Curricula; align curricula with applicable SOPs and ensure standardization across functions.
• Serve as SME on regulatory requirements and industry best practices related to Clinical Operations processes and training compliance.
• Collaborate with cross-functional teams to address training gaps and develop training materials; lead and conduct training sessions.
• Drive change management initiatives to support adoption of new processes and systems; promote a culture of continuous improvement and quality mindset across Clinical Operations.

Qualifications

• Bachelor‚Äôs degree in Life Sciences, Business, Engineering, or a related field; Master‚Äôs degree preferred.
• Targeting 10 years of relevant progressive experience in clinical operations, with a focus on operational excellence and process improvement.
• Demonstrated experience in leading process optimization initiatives and driving operational efficiencies in a global clinical trial setting.
• Strong clinical operations and project management skills with expertise in process improvement methodologies (e.g., Lean, Six Sigma).
• Previous management experience with demonstrated leadership capabilities.
• Excellent communication and interpersonal skills, with the ability to work effectively across teams and with external vendors.
• Proficiency in clinical operations systems and tools such as CTMS, eTMF, Veeva Vault platforms (Quality Docs, Clinical, Safety, RIM, Change Control, CAPA, Audits, Complaints, QRM, Supplier Management) and related platforms.
• Must be able to travel on occasion.

Skills

• Process optimization leadership in global clinical trials
• Lean Six Sigma and other process improvement methodologies
• Clinical operations systems proficiency (CTMS, eTMF, Veeva Vault, etc.)
• Cross-functional collaboration and stakeholder management
• Data-driven decision making and performance metrics

Education

• Bachelor‚Äôs degree required; Master‚Äôs preferred (Life Sciences, Business, Engineering or related field)

Additional Requirements

• Must be able to travel on occasion.