Consultant, Clinical Compliance & Operational Excellence

Just in Time GCP; Warrington Township (Bucks County); Remote; USD 130,000 - 145,000; Full time

Job summary

A leading company in clinical compliance is seeking a Consultant for Clinical Compliance & Operational Excellence. This role involves engaging clients, optimizing processes, and ensuring inspection readiness. Ideal candidates will have significant experience in clinical operations and a strong grasp of regulatory standards.

Benefits

Flexible Work Environment

Competitive Compensation

Work-Life Balance

Comprehensive Healthcare

Retirement Savings Plan

Collaborative Culture

Qualifications

• Minimum 8 years of experience in clinical development or compliance.
• Strong understanding of GCP, ICH, and inspection readiness.

Responsibilities

• Contribute subject matter expertise to projects focused on process optimization.
• Conduct process reviews and contribute to SOP development.
• Develop client-facing tools to promote sustainability.

Skills

Communication

Analytical

Problem Solving

Education

Bachelor's degree

Job description

Consultant, Clinical Compliance & Operational Excellence

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Consultant, Clinical Compliance & Operational Excellence

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Join to apply for the Consultant, Clinical Compliance & Operational Excellence role at Just in Time GCP

**Join the Just in Time GCP Team**

At Just in Time GCP, we simplify clinical compliance to clear the path forward for biotech and pharma sponsors. Our work helps organizations meet GCP expectations with confidence---so that compliance never slows down progress.

We're currently looking for a Consultant, Clinical Compliance & Operational Excellence to join our team of experts delivering high-quality support across the life sciences industry.

**What You'll Do**

In this role, you'll contribute to our mission of helping clients build strong, inspection-ready systems and processes.

Responsibilities Include

**Client Engagement & Delivery**

• Contribute subject matter expertise and hands-on support to projects focused on process optimization, compliance, and inspection readiness
• Lead and/or support assigned workstream and activities and develop/contribute to key deliverables such as reports, analysis, and visualizations to ensure quality outputs
  
  

**Clinical Compliance & Operational Expertise**

• Conduct process reviews, gap analyses, and risk assessments and contribute to SOP development aligned with GCP, while supporting compliance assessments to identify gaps and areas for improvement
• Apply knowledge of global GCP, ICH, and regulatory standards to support the development of client solutions
  
  

**Collaboration & Team Contribution**

• Collaborate with internal JiT team members to ensure effective execution of project activities and shared delivery of work products
• Provide input and analysis to assist senior consultants in driving client programs forward, while contributing to internal knowledge-sharing by refining tools, templates, and methodologies
  
  

**Client Enablement & Education**

• Develop client-facing tools (e.g., checklists, frameworks) to promote sustainability and operational readiness
• Participate in client workshops and working sessions to guide clients on process development and change adoption
  
  

**Continuous Improvement & Process Excellence**

• Identify and propose enhancements to improve consulting delivery, internal tools, and service offerings
• Stay up to date with regulatory trends and industry best practices to improve project outcomes.
  
  

**What You Bring**

We're looking for someone who brings a combination of expertise, initiative, and collaboration. Ideal candidates will have:

• Bachelor's degree required or equivalent combination of education and experience
• Minimum 8 years of experience in clinical development, clinical operations, or clinical compliance, with a focus on GCP, quality, and/or inspection readiness
• Strong understanding of GCP, ICH, inspection readiness, and relevant clinical trial regulations, with the ability to apply them in practical settings
• Experience managing or supporting consulting projects, managing workstreams, and engaging with client stakeholders
• Excellent written and verbal communication skills with an ability to clearly convey complex topics to diverse audiences
• Strong analytical, critical thinking, and problem-solving skills to identify gaps, inefficiencies, and risks within clinical trial processes
  
  

You'll thrive here if you value high-quality outcomes, communicate with clarity, and embrace innovation to make an impact.

• Why Choose Just in Time GCP for Your Next Career Move?**
  
  

At Just In Time GCP, We Take Pride In Knowing Our Work Helps Bring Safe, Effective Treatments To Patients Faster. Our Team Operates In a Dynamic, Results-driven Environment Shaped By Our Core Values

• **Quality** -- We strive to exceed expectations in every experience
• **Visionary Thinking** -- We anticipate change and shape better outcomes
• **Entrepreneurial Spirit** -- We believe creativity and leadership build smarter solutions
• **Collaboration** -- We build strong partnerships through communication and strategy
• **Innovation** -- We embrace change to solve problems and drive progress
  
  

You'll be part of a team that values people, purpose, and performance in equal measure.

**What You'll Enjoy as Part of Our Team**

• **Flexible Work Environment** -- Remote and hybrid roles available
• **Competitive Compensation** -- Reflective of your skills and the value you bring
• ** Work-Life Balance** -- PTO, paid holidays, and summer half-day Fridays
• **Comprehensive Healthcare** -- Medical, dental, vision, life insurance, and income protection
• **Retirement Savings Plan** -- Includes a company match
• **Collaborative Culture** -- Join a team that enjoys what we do and supports one another
  
  

**Location Requirement**

To be eligible for consideration, candidates must reside in one of the following states: Pennsylvania, North Carolina, Kansas, Missouri, Florida, Indiana, Virginia, South Carolina, Texas, or New Jersey.

• Ready to Make an Impact?**
  
  

If this sounds like the right fit, we invite you to apply and join a team that's moving clinical research forward with confidence.

Applicants must be authorized to work in the United States at the time of application. We do not offer visa sponsorship and are not considering candidates with F-1/OPT work authorization.

Need an accommodation during the application process? Reach out to [e-mail] --- we're happy to assist.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Business Consulting and Services

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