Provide strategic and operational leadership for an enterprise clinical research program: grow partnerships, manage multi-site operations, oversee quality and regulatory compliance, own financial performance and budgeting, implement research technology and data governance, and recruit and develop investigators and research staff.
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:
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.
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.
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.
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.
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