Remote eClinical Systems Consultant: Enablement

Just in Time GCP; Warrington Township (Bucks County); Hybrid; USD 110,000 - 150,000; Full time

Benefits offered by this job

Flexible Work Environment

Competitive Compensation

Work-Life Balance

Comprehensive Healthcare

Retirement Savings Plan

Collaborative Culture

Job summary

Just in Time GCP in the United States seeks a Consultant, eClinical Systems & Operational Enablement to lead and support eClinical systems workstreams (eTMF, CTMS, QMS, EDC) with a focus on regulatory compliance and operational efficiency.

You will run client workshops, develop validation plans, translate business needs into technology solutions, and collaborate with vendors and internal teams to deliver high‑quality, compliant deployments.

Qualifications

• Bachelor's degree in a relevant field (e.g., Life Sciences, Information Systems, or equivalent) required.
• 4-6 years of consulting or clinical operations experience with a focus on eClinical systems (e.g., Veeva Vault, Documentum, SharePoint, Medidata, or equivalent)
• Hands-on experience with system validation and migration, including execution of validation documentation and test scripts
• Strong understanding of GCP, 21 CFR Part 11, Annex 11, and industry standards for compliant eClinical system deployment and maintenance
• Proven ability to translate business requirements into technology solutions that ensure compliance, usability, and operational impact
• Demonstrated experience leading system workshops, configuration sessions, and vendor coordination within a regulated environment
• Strong analytical, organizational, and communication skills, with the ability to synthesize information into clear, client-ready deliverables
• Proficiency in Microsoft Office, with ability to prepare polished presentations, summaries, reports, and visual process materials
• Veeva Vault certification or experience across Veeva modules (eTMF, QMS, CTMS) preferred
• Demonstrated ability to work independently and collaboratively across functional teams and client stakeholders
• Contribute to business development through high-quality project delivery, building strong client relationships, identifying potential opportunities for service expansion, and sharing observations that support Just in Time GCP's growth initiatives

Responsibilities

• Lead or support assigned eClinical systems workstreams of moderate complexity, ensuring regulatory compliance, operational efficiency, and alignment with client goals
• Conduct gap assessments and develop process flows, RACI charts, and actionable recommendations that support system optimization and compliance
• Facilitate or support client workshops, stakeholder meetings, and documentation sessions to guide system configuration, validation, migration, and implementation activities
• Prepare and review consulting deliverables, including process documentation, training materials, validation plans, and implementation strategies
• Collaborate closely with client stakeholders, technology vendors, and internal Just in Time GCP teams to maintain alignment on priorities, deliverables, and quality standards
• Ensure all project activities adhere to Good Clinical Practice (GCP), internal SOPs, and applicable regulatory frameworks (e.g., 21 CFR Part 11, Annex 11)
• Support data migration, validation, and user acceptance testing (UAT) processes, ensuring system readiness and compliance
• Contribute to business development by supporting proposals, presenting technical capabilities, and shaping system-related solutions

Skills

eClinical systems

Stakeholder management

Workshop leadership

Regulatory compliance

Education

Bachelor's degree in Life Sciences, Information Systems, or equivalent

Tools

Veeva Vault

Documentum

SharePoint

Medidata

eTMF

CTMS

Job description

Just in Time GCP in the United States seeks a Consultant, eClinical Systems & Operational Enablement to lead and support eClinical systems workstreams (eTMF, CTMS, QMS, EDC) with a focus on regulatory compliance and operational efficiency.

You will run client workshops, develop validation plans, translate business needs into technology solutions, and collaborate with vendors and internal teams to deliver high‑quality, compliant deployments.