What are the responsibilities and job description for the Clinical Operation，（Sr.）Director position at IntelliPro?
Department: Clinical Development
Reports To: Vice President, Clinical Development
Position Summary
The Director, Clinical Operations will provide strategic leadership and oversight for the planning, execution, and management of multiple clinical trials across phases (I-III). This role is responsible for ensuring trials are conducted in compliance with GCP, regulatory requirements, and company objectives, while meeting timelines, quality standards, and budgetary goals. The ideal candidate will bring strong operational expertise, team management experience, and a proactive approach to problem-solving in a fast-paced environment.
Key Responsibilities
· Lead the Clinical Operations team, including Clinical Trial Managers and CRAs, providing mentorship, guidance, and performance management.
· Develop and implement clinical operational strategies, including site selection, patient recruitment, monitoring plans, and risk management.
· Oversee the end-to-end execution of clinical trials, ensuring adherence to protocols, timelines, and budgets.
· Manage relationships with CROs, vendors, and investigative sites, ensuring performance and quality standards are met.
· Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, and Safety teams.
· Contribute to the development of key study documents (protocols, CRFs, manuals, reports) and regulatory submissions.
· Monitor trial progress, identify issues, and implement corrective actions to ensure study integrity and patient safety.
· Ensure compliance with FDA, ICH-GCP, and other applicable regulatory guidelines.
· Prepare and manage clinical trial budgets, resource planning, and forecasting.
· Support business development activities, including evaluation of new therapeutic areas or partnership opportunities.
Reports To: Vice President, Clinical Development
Position Summary
The Director, Clinical Operations will provide strategic leadership and oversight for the planning, execution, and management of multiple clinical trials across phases (I-III). This role is responsible for ensuring trials are conducted in compliance with GCP, regulatory requirements, and company objectives, while meeting timelines, quality standards, and budgetary goals. The ideal candidate will bring strong operational expertise, team management experience, and a proactive approach to problem-solving in a fast-paced environment.
Key Responsibilities
· Lead the Clinical Operations team, including Clinical Trial Managers and CRAs, providing mentorship, guidance, and performance management.
· Develop and implement clinical operational strategies, including site selection, patient recruitment, monitoring plans, and risk management.
· Oversee the end-to-end execution of clinical trials, ensuring adherence to protocols, timelines, and budgets.
· Manage relationships with CROs, vendors, and investigative sites, ensuring performance and quality standards are met.
· Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, and Safety teams.
· Contribute to the development of key study documents (protocols, CRFs, manuals, reports) and regulatory submissions.
· Monitor trial progress, identify issues, and implement corrective actions to ensure study integrity and patient safety.
· Ensure compliance with FDA, ICH-GCP, and other applicable regulatory guidelines.
· Prepare and manage clinical trial budgets, resource planning, and forecasting.
· Support business development activities, including evaluation of new therapeutic areas or partnership opportunities.