Director, Clinical Research Operations Transformation
Hybrid · Orange, New Jersey, United States
Job Summary
Director-level leadership for transforming and scaling a cardiovascular clinical research operation across multiple hospital campuses and ambulatory sites. You will design and launch enterprise-wide operational initiatives, standardize workflows and performance metrics, enhance investigator engagement and cross-system coordination, and build scalable infrastructure and service-line activation frameworks to accelerate study activation and improve start-up predictability. The role emphasizes collaboration with executive, clinical, and administrative leadership, and requires governance navigation in complex academic-clinical environments. The opportunity includes designing a cardiovascular research pilot, managing multi-site operations from concept to execution, and delivering a high-performing, compliant research enterprise with strong sponsor and CRO partnerships and a demonstrated ability to drive operational transformation. Strengths in CTMS (OnCore) and Epic research integration, research billing compliance, SOP development, and dashboard-based performance management are highly valued.
Required Qualifications
- Bachelor’s degree required; Master’s degree in Clinical Research Administration, Public Health, Nursing, or related field strongly preferred
- Minimum of 7 to 10 years of progressive clinical research operations experience
- 3 to 5 years in leadership or management roles
- Experience building and launching a multi-location clinical research operation from scratch
- Experience leading complex multi-site clinical research settings (academic medical centers, affiliated and non-academic health systems)
- Experience managing complex drug, device, adaptive, or multi-arm trials
- Cardiovascular clinical research experience strongly preferred
- Expertise in study start-up optimization, IRB processes, and regulatory compliance
- Experience with CTMS platforms (e.g., OnCore) and Epic research integration
- Strong knowledge of research billing compliance and Medicare clinical trial requirements
- Proven ability to develop SOPs, quality systems, and performance dashboards
- Experience building relationships with sponsors and CRO partners
- Strong executive presence with the ability to influence across matrixed environments
- Demonstrated success leading operational transformation or research program development initiatives
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