Sarah Cannon Research Institute · 1 day ago
Sr. Director, Project Management & Clinical Affairs - Remote US
United States
Full-time
Remote
Director/Executive
10+ years expSarah Cannon Research Institute (SCRI) is a leading oncology research organization focused on advancing therapies for cancer patients. The Senior Director of Project Management and Clinical Affairs will oversee daily operations and strategic direction for the departments, ensuring compliance and successful delivery of services for clinical trials while managing departmental budgets and fostering team development.
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
Qualification
Required
Bachelor Degree required
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 an Associate 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
Preferred
Master's Degree highly preferred
Benefits
Comprehensive benefits to support physical, mental, and financial well-being
Competitive compensation package
Annual bonus or long-term incentive opportunities
Company
Sarah Cannon Research Institute
Sarah Cannon Research Institute is one of the world’s leading oncology research organizations conducting community-based clinical trials.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Deepak Bhamidipati
Assistant Director of Drug Development
Recent News
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