Senior Consultant, Clinical Compliance & Operational Excellence

Just In Time GCP; Warrington Township (Bucks County); Hybrid; USD 110,000 - 170,000; Full time

Benefits offered by this job

Flexible work environment

Remote and hybrid roles

Competitive compensation

PTO & holidays

Healthcare & life insurance

Retirement plan match

Collaborative culture

Job summary

Just in Time GCP is seeking a Senior Consultant, Clinical Compliance & Operational Excellence to lead complex engagements across the life sciences sector. You will guide client discussions, shape delivery plans, and drive quality outcomes with independence.

The role requires 7+ years in consulting or clinical operations, with advanced knowledge in TMF, clinical compliance, and inspection readiness. Flexible remote/hybrid work options and a collaborative, growth-focused team await.

Qualifications

• Bachelor’s degree in a relevant field or equivalent combination of education and experience.
• Typically 7+ years of relevant consulting, clinical operations, quality, technology, or life sciences experience.
• Proven ability to lead complex workstreams or defined consulting engagements with substantial independence.
• Advanced knowledge in Just in Time GCP consulting domains such as business process, TMF, clinical compliance, clinical systems, inspection readiness, migration, validation.

Responsibilities

• Lead complex workstreams or defined engagements within agreed outcomes, scope, quality expectations and timelines.
• Guide client discussions, workshops, analysis, and recommendations; coordinate delivery activities and manage issues or escalations.
• Support scoping, proposal development, client presentations, and expansion discussions using delivery experience and client insight.
• Identify emerging client needs and communicate opportunities to account or engagement leadership.
• Provide focused expertise in one or more consulting domains and guide others on complex issues.
• Develop or improve consulting methods, templates, accelerators, and reusable assets.
• Coach Consultants and Associate Consultants, review work for quality, and develop consulting judgment.
• Lead focused improvements to delivery methods, tools, or internal processes.

Skills

Leadership

Stakeholder management

Workshop facilitation

Analytical skills

Recommendation development

Education

Bachelor's degree

Job description

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 Senior 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 Delivery

• Lead complex workstreams or defined engagements within agreed outcomes, scope, quality expectations, and timelines.
• Guide client discussions, workshops, analysis, and recommendations; coordinate delivery activities and ensure issues and dependencies are addressed or escalated appropriately.

Business Growth & Market Influence

• Support scoping, proposal development, client presentations, and expansion discussions by applying delivery experience and client insight.
• Identify emerging client needs and communicate relevant opportunities to account or engagement leadership.

Domain / Capability Leadership

• Provide focused expertise in one or more consulting domains, guide others on complex issues, and contribute to quality and risk decisions.

Methods, Assets & Offerings

• Develop or materially improve consulting methods, templates, accelerators, and reusable assets based on project experience.

People & Practice Development

• Coach Consultants and Associate Consultants, review work for quality, and help develop stronger consulting judgment and delivery capability.

Innovation & Continuous Improvement

• Lead focused improvements to delivery methods, tools, or internal processes and help teams adopt more effective ways of working.

What You Bring

• Bachelor’s degree in a relevant field or equivalent combination of education and experience.
• Typically 7+ years of relevant consulting, clinical operations, quality, technology, or life sciences experience.
• Proven ability to lead complex workstreams or defined consulting engagements with substantial independence.
• Advanced knowledge in one or more Just in Time GCP consulting domains, such as business process, TMF, clinical compliance, clinical systems, inspection readiness, migration, validation, or related areas.
• Demonstrated mentoring, stakeholder‑management, workshop, analytical, and recommendation‑development skills.

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

• Community. We build meaningful relationships with our employees, clients, and partners, fostering a collaborative environment where everyone feels supported, valued, and empowered
• Pioneer. We lead with curiosity and innovation, continuously seeking better ways to solve complex challenges
• Premier. We are committed to excellence, delivering high-quality solutions that exceed expectations
• Steadfast. We act with integrity and reliability, standing firm in our commitment to our clients, our team, and our mission

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, South Carolina, Massachusetts, Texas, Georgia or New Jersey.

Ready to Make an Impact?

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.

Just in Time GCP endeavors to make the application process accessible to all users. If you need assistance completing the application process, please contact Just in Time GCP Human Resources at [e-mail]. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

Just in Time GCP is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Just in Time GCP. Empowered People. Trusted Partners. Meaningful Impact.