Senior Consultant, eClinical Systems & Operational Enablement

Just in Time GCP; Warrington Township (Bucks County); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Flexible work environment

Competitive compensation

Job summary

Just in Time GCP is seeking a Senior Consultant to align clinical technology, processes, data, and quality to support inspection-ready systems across the life sciences sector.

You will lead complex eClinical workstreams, run cross-functional workshops, and translate business needs into actionable system requirements, configurations, and migrations, while advancing AI-enabled improvements in regulated environments.

Qualifications

• Bachelor's degree in a relevant field or equivalent combination of education and experience.
• Typically 7+ years of relevant eClinical systems, clinical technology, clinical operations, life sciences consulting, or related regulated-industry experience.
• Proven ability to lead complex workstreams or defined consulting engagements with substantial independence.
• Experience with Veeva Vault (Clinical, Quality), or comparable regulated life sciences technology platforms is preferred. Certifications or qualifications desirable.
• Working knowledge of GCP, 21 CFR Part 11, Annex 11, data integrity principles, and computerized system validation expectations relevant to regulated clinical technology.
• Strong client-facing consulting, workshop facilitation, stakeholder management, problem solving, recommendation development, and communication skills.
• Curiosity and learning agility to deepen expertise in one area while expanding into adjacent clinical technologies and emerging capabilities, including an interest in exploring how AI and automation can improve clinical systems, processes, and delivery.

Responsibilities

• Independently lead complex eClinical workstreams or defined engagements involving system implementation, configuration, optimization, migration, requirements gathering, process and workflow design, validation and UAT, solution design, operational readiness, and system or process assessments.
• Lead cross-functional workshops and solutioning sessions with client Clinical Operations, Quality, IT, Data Management, and technology or vendor stakeholders.
• Translate clinical and business needs into practical system requirements, workflows, configurations, data mapping, system and data migration, reconciliation, transition requirements, and implementation recommendations.
• Exercise sound judgment to guide analysis, delivery activities, risks, dependencies, and delivery issues appropriately.
• Support scoping, proposal development, client presentations, and expansion discussions for eClinical systems and technology-enabled services by applying delivery experience and client insight.
• Identify emerging client needs related to clinical technology, system adoption, data, operational readiness, and technology-enabled service opportunities; communicate relevant opportunities to account or engagement leadership.
• Provide focused expertise in one or more eClinical technology domains, with emphasis on Veeva Vault; guide clients and team members on complex issues and how technology supports clinical operations, quality, GCP compliance, data integrity, oversight, and inspection readiness.
• Develop or materially improve eClinical methods, templates, tools, accelerators, migration approaches, and other reusable assets based on project experience.
• Coach Consultants and Associate Consultants, review work for quality, share expertise, and help develop stronger consulting and eClinical delivery capabilities.
• Lead focused improvements to eClinical delivery methods, tools, or internal processes, including practical uses of automation and AI in regulated environments.

Skills

eClinical systems

Veeva Vault

GCP compliance

data integrity

stakeholder management

workshop facilitation

client-facing

change enablement

AI in regulated environments

systems validation

Education

Bachelor's degree or equivalent

Tools

Veeva Vault

Regulated life sciences platforms

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, eClinical Systems & Operational Enablement** to join our team of experts delivering high-quality support across the life sciences industry.

**What You'll Do**

In this role, you'll help clients align clinical technology, business processes, data, people, and regulatory and quality expectations to build strong, inspection-ready systems and ways of working.

**Responsibilities Include**

**Client Delivery**

• Independently lead complex eClinical workstreams or defined engagements involving system implementation, configuration, optimization, migration, requirements gathering, process and workflow design, validation and UAT, solution design, operational readiness, and system or process assessments.
• Lead cross-functional workshops and solutioning sessions with client Clinical Operations, Quality, IT, Data Management, and technology or vendor stakeholders.
• Translate clinical and business needs into practical system requirements, workflows, configurations, data mapping, system and data migration, reconciliation, transition requirements, and implementation recommendations.
• Exercise sound judgment to guide analysis, delivery activities, risks, dependencies, and delivery issues appropriately.

**Business Growth & Market Influence**

• Support scoping, proposal development, client presentations, and expansion discussions for eClinical systems and technology-enabled services by applying delivery experience and client insight.
• Identify emerging client needs related to clinical technology, system adoption, data, operational readiness, and technology-enabled service opportunities; communicate relevant opportunities to account or engagement leadership.

**Domain / Capability Leadership**

• Provide focused expertise in one or more eClinical technology domains, with particular emphasis on Veeva Vault (e.g. Clinical, Quality). Experience with other comparable regulated life sciences technology platforms is also valued.
• Guide clients and team members on complex issues and how technology supports clinical operations, quality, GCP compliance, data integrity, oversight, and inspection readiness.

**Methods, Assets & Offerings**

• Develop or materially improve eClinical methods, templates, tools, accelerators, migration approaches, and other reusable assets based on project experience.

**People & Practice Development**

• Coach Consultants and Associate Consultants, review work for quality, share expertise, and help develop stronger consulting and eClinical delivery capabilities.

**Innovation & Continuous Improvement**

• Lead focused improvements to eClinical delivery methods, tools, or internal processes, including practical uses of automation and AI in regulated environments, and help teams adopt more effective ways of working.

**What You Bring**

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

• Bachelor's degree in a relevant field or equivalent combination of education and experience.
• Typically 7+ years of relevant eClinical systems, clinical technology, clinical operations, life sciences consulting, or related regulated-industry experience.
• Proven ability to lead complex workstreams or defined consulting engagements with substantial independence.
• Experience in one or more areas such as system implementation or configuration, optimization, data and system migration, requirements or process design, testing/UAT, validation, operational readiness, and training/change enablement.
• Experience with Veeva Vault (Clinical, Quality), or comparable regulated life sciences t chnology platforms is preferred. Veeva certifications or other relevant system certifications or qualifications are desirable.
• Working knowledge of GCP, 21 CFR Part 11, Annex 11, data integrity principles, and computerized system validation expectations relevant to regulated clinical technology.
• Strong understanding of clinical operations and/or clinical quality processes, with the ability to connect technology decisions to the business processes, data, roles, and GCP responsibilities they support.
• Strong client-facing consulting, workshop facilitation, stakeholder management, problem solving, recommendation development, and communication skills with both technical and non-technical audiences.
• Curiosity and learning agility to deepen expertise in one area while expanding into adjacent clinical technologies and emerging capabilities, including an interest in exploring how AI and automation can improve clinical systems, processes, and delivery.

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

• **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.

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

• Flexible Work Environment.** Remote and hybrid roles available.
• Competitive Compensation.** Reflective of your skills and the value you bring.

**Work-Life Balance.**