Senior eClinical Systems & Ops Enablement Consultant

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

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.