Director Clinical Systems and Process

BIOTECH: Director, Business Operations in Clinical Operations.

Role Overview:

The Director of Business Operations in Clinical Operations is responsible for optimizing clinical trial execution processes, ensuring compliance, and driving operational efficiency. This includes overseeing process improvements, SOP development, training, and vendor oversight, while collaborating with cross-functional teams to ensure smooth trial execution.

Key Responsibilities:

• Drive process improvements in clinical trial planning and execution.
• Develop and maintain Clinical Operations SOPs, ensuring compliance with industry regulations.
• Lead initiatives for operational excellence, including process standardization and best practices.
• Manage training and onboarding for Clinical Operations staff.
• Oversee vendor management and support clinical site oversight.
• Support inspection readiness and compliance initiatives.
• Lead and maintain clinical trial systems (e.g., CTMS, eTMF).
• Manage internal audits and corrective actions.
• Lead and mentor the Business Operations team, supporting career development.

Qualifications:

• Bachelor's or Master's degree in life sciences.
• 10+ years in clinical drug development, with 3+ years in business operations or project management.
• Expertise in global clinical trials and clinical trial systems (CTMS, IRT, EDC).
• Strong knowledge of ICH-GCP guidelines and vendor management.
• Ability to manage multiple projects and collaborate across functions.
• Proficiency in project management tools like Excel and Smartsheet.