Sr. Director, Project Management & Clinical Affairs - Remote US

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. The Senior Director of Project Management and Clinical Affairs is a key leader overseeing daily operations and strategic direction for the Project Management and Clinical Affairs departments, focusing on clinical operations and ensuring compliance and successful delivery of contracted services.

Responsibilities:

• Ensure departmental compliance with all applicable global regulations and Sarah Cannon SOPs; develop and update SOPs and processes as needed
• Monitor evolving regulatory requirements (e.g., ICH‑GCP, FDA, EMA) and update departmental practices to maintain alignment with current industry standards
• Establish and lead the clinical operations strategy, setting departmental goals and driving initiatives that support organizational objectives and a culture of accountability and continuous improvement
• Lead the evaluation and implementation of new technologies, tools, and methodologies to enhance clinical monitoring, site start‑up, and operational efficiency
• Oversee change management efforts related to new processes, systems, or organizational structures, ensuring effective communication, staff engagement, and smooth adoption
• Promote strong cross‑functional collaboration with internal stakeholders (data management, regulatory, medical affairs, IT) and external partners (vendors, CROs, investigator sites) to enable seamless operational execution
• Other duties as assigned

Requirements:

• Bachelor Degree required, Master's Degree highly preferred
• 10+ years' extensive work experience in clinical research, clinical affairs, project management including prior work experience as a CRA line manager
• Extensive experience in RBM (Risk-based Monitoring)
• CRO and Oncology experience required
• Prior experience should include minimum 2 years as a Director
• Project Management, collaboration with external partners, vendors, CROs
• Regulatory Compliance expertise
• Leadership and team building
• Thorough expertise in GCP, FDA, EMA, other regulatory guidelines
• Familiarity with data collection, handling, QA processes, including EDC and HIPAA
• Familiarity with auditing processes, CAPA, and continuous improvement methodologies
• Awareness of new technologies impacting clinical research such as decentralized trials, telemedicine, and AI
• Decision-making and change management
• Establishing operational optimization
• Exceptional customer service attitude
• Presentation and negotiation skills
• Strategic thinking, enterprise mindset, innovation and futuristic thinking