Director, Enterprise Clinical Research & Partnerships

United Digestive; Atlanta (GA); In loco; USD 150.000 - 210.000; Tempo pieno

Descrizione del lavoro

United Digestive seeks a strategic leader to head the enterprise clinical research program in Atlanta. You will drive growth, partnerships, and financial performance while maintaining compliance with FDA, ICH-GCP, and HIPAA standards.

Ideal candidates have extensive multi-site operations experience and a track record of building scalable research infrastructure. This role includes leading a team and engaging with sponsors, CROs, and academic partners.

Competenze

• Bachelor's degree required in a health/science/related field.
• 7+ years of progressive clinical research operations with multi-site leadership.
• Experience with sponsor/CRO partnerships, study portfolio strategy, budgets, contracts, and financial management.
• Knowledge of FDA regulations, ICH-GCP, HIPAA, and quality systems; strong leadership and negotiation skills.

Mansioni

• Supervise and lead Clinical Research Manager and centralized research operations staff.
• Develop and execute enterprise clinical research strategy, goals, and growth plan.
• Build partnerships with sponsors, CROs, academics, and healthcare organizations.
• Evaluate and prioritize the study portfolio for strategic fit, feasibility, capacity, and financial viability.
• Own departmental financial performance including budgets, forecasts, contracts, and terms.
• Oversee standardized multi-site research operations, resources, and performance improvement.
• Communicate barriers, and trends to executive leadership.
• Maintain Quality Management System, SOPs, CAPA plans, audits, and FDA readiness.
• Ensure compliance with FDA, ICH-GCP, HIPAA, and sponsor requirements.
• Set roadmap for research technology and data governance.
• Recruit and develop investigators and staff while promoting accountability.

Conoscenze

Strategic leadership

Financial management

Communication

People leadership

Relationship building

Formazione

Bachelor's degree in healthcare administration, business administration, life sciences, nursing, public health, or related field

Master's or doctoral degree in healthcare administration, business, public health, regulatory affairs, or related field

Descrizione del lavoro

United Digestive seeks a strategic leader to head the enterprise clinical research program in Atlanta. You will drive growth, partnerships, and financial performance while maintaining compliance with FDA, ICH-GCP, and HIPAA standards.

Ideal candidates have extensive multi-site operations experience and a track record of building scalable research infrastructure. This role includes leading a team and engaging with sponsors, CROs, and academic partners.