Director, Clinical Research Operations Transformation

Vitalief•Orange, NJ

3d•Hybrid

About The Position

We are seeking a highly experienced, strategic yet hands-on Clinical Research Operations Leader to join our delivery team as a full-time, fully benefited employee. In this role, you will partner with a multi-location community hospital system to transform its research enterprise into a scalable, high-performing, world-class clinical research operation. As the primary subject matter expert (SME), this leader will collaborate closely with the Vitalief delivery team to design and implement enterprise-level operational initiatives, with a strong emphasis on Non-Oncology programs and enhancing cross-system communication and coordination. A central focus of the role will be leading the operational build-out and execution of a Cardiovascular clinical trials pilot, including infrastructure development, staffing strategy, workflow optimization, and technology deployment.

Requirements

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, including 3 to 5 years in leadership or management roles.
Experience building and launching a clinical research multi-location operation from scratch, enabling timely initiation of multiple studies across diverse therapeutic areas.
Demonstrated experience leading and supporting complex multi-site clinical research settings, including academic medical centers, affiliated and non-academic health systems, and disparate research locations.
Demonstrated experience managing complex drug, device, adaptive, or multi-arm trials.
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 strong relationships with sponsors and CRO partners to enhance site reputation and repeat business opportunities.
Strong executive presence with the ability to influence across matrixed environments.
Demonstrated success leading operational transformation or research program development initiatives.

Nice To Haves

Cardiovascular clinical research experience strongly preferred.

Responsibilities

Successful design, launch and operational stabilization of a scalable Cardiovascular research pilot across multiple hospital campuses and ambulatory sites.
Aligned research strategy with institutional priorities through close partnership with executive, clinical, and administrative leadership.
Established standardized workflows, SOPs and enterprise-wide performance metrics for research operations.
Strengthened investigator engagement and increased research participation across service lines.
Established scalable infrastructure and service line activation frameworks, in collaboration with investigators and sponsors, to reduce study activation timelines, enhance start-up predictability, and support sustainable research growth.
Successfully managed cross-functional initiatives within matrixed reporting environments and complex academic-clinical governance structures.
Transition from opportunistic research conduct to a deliberate, strategic, and scalable clinical research enterprise.