Director, Clinical Research Operations Transformation

Vitalief; Orange (NJ); Hybrid; USD 160,000 - 190,000; Full time

Benefits offered by this job

20 PTO days

9 paid holidays

Company-paid life insurance

Short- and long-term disability

401(k) retirement plan

Robust healthcare options

Hybrid work model (2–3 days onsite)

Equity incentives

Performance bonus

Job summary

Vitalief is seeking a Director of Clinical Research Operations Transformation to lead a multi-site cardiovascular research initiative in partnership with a regional hospital system. The role is hybrid, with 2–3 days onsite in Orange, NJ, and involves designing scalable processes, implementing enterprise-wide standards, and driving operational excellence across sites.

The ideal candidate will bring 7–10 years in clinical research operations, with leadership experience, expertise in CTMS (OnCore)

Qualifications

• Bachelor’s degree required; Master’s degree strongly preferred.
• Minimum 7–10 years of progressive clinical research operations experience including 3–5 years in leadership.
• Experience building multi-location clinical research operations from scratch.

Responsibilities

• Design, launch, and stabilize a scalable cardiovascular research pilot across multiple sites.
• Align research strategy with institutional priorities through leadership collaboration.
• Establish SOPs, workflows, and enterprise-wide performance metrics.
• Strengthen investigator engagement and expand participation across service lines.
• Develop infrastructure and activation frameworks to reduce timelines and improve start-up reliability.
• Lead cross-functional initiatives in matrixed, academic-clinical environments.

Skills

Leadership experience

Strategic planning

Cross-functional collaboration

Stakeholder engagement

CTMS (OnCore)

Epic research integration

Regulatory compliance

Education

Bachelor’s degree

Master’s degree in Clinical Research Administration/ related field

Tools

OnCore CTMS

Epic Research

Job description

Director, Clinical Research Operations Transformation

ABOUT VITALIEF Vitalief is a trusted partner to Sponsors, CROs, and Sites across the research and clinical trials landscape. By blending deep subject matter expertise with strong business acumen, we deliver Consulting and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients.

POSITION OVERVIEW

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.

WHY VITALIEF?

• Professional Growth: Join a team of experienced practitioners who bring both business acumen and domain expertise.
• Impactful Work: Contribute to scientific advancements that directly improve patient lives.
• People-First Culture: Thrive in an environment that fosters growth, innovation, and collaboration.
• Comprehensive Benefits: Enjoy 20 PTO days, 9 paid holidays, company-paid life insurance, short- and long-term disability, a 401(k) retirement plan, and robust healthcare options.
• Flexible Work Location: Hybrid role with 2-3 days per week onsite in the Orange, NJ area.
• Competitive Compensation: $160,000 to $190,000 plus performance bonus, and equity incentives.

KEY RESPONSIBILITIES – What Success Looks Like

• 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.

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, 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.
• 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 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.

PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs.

IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on‑site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.

Do you currently live within daily commutable distance to the Orange, NJ area?

Do you have a Bachelor’s degree?

Will you now, or in the future, require visa sponsorship for employment (e.g., currently OPT, H-1B visa)?

Do you have at least 3 years of progressive clinical research operations management experience?

Do you have experience building, launching and leading a clinical research multi‑location operation from scratch, enabling timely initiation of multiple studies across diverse therapeutic areas?

Do you have experience conducting cardiovascular clinical trials, either as an individual contributor or in an operational management role?

Please list the different types of clinical research sites you have worked at: Academic Medical Centers Outpatient Medical Centers University Hospitals Non-Academic Community Hospitals Private Physician Practices Independent Research Centers Site Management Organizations (SMO) Contract Research Organizations (CRO) - Affiliated Sites Site Networks / Multi-site Research Networks Virtual / Decentralized Clinical Trial (DCT) Sites