Senior Director, Clinical Research Operations

Vitalief; New Jersey; Hybrid; USD 100,000 - 140,000; Full time

Benefits offered by this job

20 PTO days

9 paid holidays

Company-paid life insurance

401(k) retirement plan

Robust healthcare options

Performance bonuses

Equity incentives

Job summary

A healthcare consulting firm is seeking a Clinical Research Operations Leader in New Jersey to enhance clinical research operations. The role involves launching and managing a Cardiovascular research pilot across hospital sites and requires 7-10 years of experience in clinical research operations, with leadership responsibilities. Candidates should possess a Bachelor's degree, with a Master's preferred, and have experience with multi-site operations. The position supports professional growth, offers a hybrid work environment, and includes comprehensive benefits.

Qualifications

• Bachelor's degree required; Master's degree preferred.
• 7 to 10 years of clinical research operations experience.
• Experience in leadership roles.
• Experience with multi-site clinical research settings.
• Expertise in regulatory compliance.

Responsibilities

• Design, launch, and stabilize Cardiovascular research pilot.
• Align research strategy with executive leadership.
• Establish standardized workflows for research operations.
• Strengthen investigator engagement and increase participation.
• Manage cross-functional initiatives within complex governance.

Skills

Clinical research operations experience

Leadership

Communication

Project management

Relationship building with sponsors

Education

Bachelor's degree

Master's degree in Clinical Research Administration or related field

Tools

CTMS platforms (e.g., OnCore)

Epic research integration

Job description

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: Base salary, 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 building 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 require 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.