Associate Director, Clinical Operations Excellence – Standards Lead

This is a fully remote position, open to applicants in California.

📋 Description

• Collaborates with leadership in the department to develop, establish, enhance, and sustain operational processes.

• Takes the lead in the creation and refinement of departmental SOPs, guidance documents, and policies.

• Manages the framework of processes within Clinical Operations to guarantee continuity and transparency.

• Designs and evaluates training for SOPs, work practices, and forms.

• Acts as the primary point of contact for standards-related inquiries.

• Engages in reviews and participates in working groups.

• Writes, updates, and oversees Clinical Operations SOPs and templates.

• Ensures adherence to document version control, archiving, and periodic review processes.

• Collaborates with Clinical Operation leaders and study teams.

• Develops and implements rollout strategies for new and updated standards.

• Monitors the adoption and effectiveness of standards.

• Collects user feedback and analyzes trends and issues.

⛳️ Requirements

• Bachelor’s degree in a relevant field.

• At least 8 years of experience in clinical operations and/or clinical trial operations.

• Proven experience in authoring and implementing SOPs, templates, work instructions, or other controlled documents within a regulated environment.

• Strong grasp of GCP/ICH principles and the activities associated with the clinical trial lifecycle.

• Proficient in Microsoft Office Suite.

• Exceptional verbal and written communication capabilities.

• Ability to work both independently and as part of a team.

• Analytical thinker with strong problem-solving abilities.

• Excellent skills in planning, organization, and time management.

• Willingness to travel 20-30% of the time.

🏝️ Benefits

• Short- and long-term incentives.

• Medical, dental, and vision insurance plans.

• Retirement savings plans.