Director of Clinical Research (68742)

United Digestive; Dunwoody (GA); Vor Ort; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

United Digestive seeks a senior leader to provide strategic and operational leadership for its enterprise clinical research program. You will drive growth, partnerships, financial performance, quality, and infrastructure across multiple sites while ensuring FDA, ICH-GCP, and HIPAA compliance.

Exceptional candidates with experience beyond the posted level may be considered for higher levels. Travel and on-site leadership are expected to advance program reach and impact.

Qualifikationen

• Bachelor's degree in healthcare administration, life sciences, or related field.
• Seven+ years of progressive clinical research operations experience.
• Experience with sponsor/CRO partnerships, budgets, and contracts.
• Knowledge of FDA regulations, ICH-GCP, HIPAA, and quality systems.

Aufgaben

• Provide strategic and operational leadership for enterprise clinical research.
• Oversee multi-site operations, budgets, forecasts, and contracts.
• Build sponsor, CRO, academic, and healthcare partnerships.
• Ensure regulatory compliance with FDA, ICH-GCP, and HIPAA.
• Recruit and develop investigators and staff, fostering improvement.
• Set roadmap for data governance, tools, and infrastructure.

Kenntnisse

Strategic leadership

Clinical research operations

Budget management

Regulatory knowledge

Negotiation

Ausbildung

Bachelor's degree in healthcare administration

Master's degree (preferred)

Doctoral degree (preferred)

Jobbeschreibung

GENERAL SUMMARY OF DUTIES:

Provides strategic and operational leadership for United Digestive's enterprise clinical research program, with accountability for growth, partnerships, financial performance, quality, compliance, infrastructure, and talent.

Exceptional candidates with experience beyond the posted level are encouraged to apply. Based on qualifications, experience, and organizational needs, consideration may be given to placement at a higher level.

Responsibilities

Duties include but are not limited to:

• Supervise and provide leadership to Clinical Research Manager and centralized research operations staff


• Develop and execute United Digestive's enterprise clinical research strategy, goals, growth plan, and scalable infrastructure


• Build sponsor, CRO, academic, and healthcare partnerships that expand study opportunities, investigator participation, and program reach


• Evaluate and prioritize the study portfolio based on strategic fit, feasibility, capacity, patient population, and financial viability


• Own departmental financial performance, including budgets, forecasts, sponsor budgets, contracts, and key business terms


• Oversee standardized multi-site research operations, resource allocation, systems, and performance improvement


• Remove barriers and communicate operational, financial, enrollment, startup, and quality trends to executive leadership


• Maintain oversight of the Quality Management System, SOPs, CAPA plans, audits, and FDA inspection readiness


• Ensure compliance with FDA regulations, ICH-GCP, HIPAA, institutional policies, and sponsor requirements


• Set the roadmap for research technology, data governance, and standardized tools that support efficient, reliable operations


• Recruit and develop investigators, leaders, and research staff while fostering accountability and continuous improvement

Education, Skills, & Experience

• Required:
  
  
  
  • Bachelor's degree in healthcare administration, business administration, life sciences, nursing, public health, or a related field
  
  
  • At least seven years of progressive clinical research operations experience, including multi-site program leadership and direct staff management
  
  
  • Experience with sponsor/CRO partnerships, study portfolio strategy, budgets, contracts, and departmental financial management
  
  
  • Knowledge of FDA regulations, ICH-GCP, HIPAA, and quality systems, with strong strategic, communication, negotiation, and people-leadership skills
  
  
  
  


• Preferred:
  
  
  
  • Master's or doctoral degree in healthcare administration, business, public health, regulatory affairs, or a related field
  
  
  • Clinical research certification and experience with enterprise research technologies
  
  
  
  

Work Environment

Requires sitting and standing associated with a normal office environment. Travel required as business needs dictate.

Drug Free Workplace

United Digestive is a drug-free workplace. All offers of employment are contingent upon passing a pre-employment drug screening.

Equal Opportunity Employer

United Digestive is an equal opportunity employer and will not tolerate discrimination in employment on the basis of race, color, age, sex, sexual orientation, gender identity or expression, religion, disability, ethnicity, national origin, marital status, veteran status, genetic information or any other legally protected classification or status.