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, eClinical Systems & Operational Enablement to join our team of experts delivering high-quality support excellence 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:
- Lead or support assigned eClinical systems (eTMF, CTMS, QMS, EDC, and related platforms) 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
What You Bring
You’ll thrive here if you value high-quality outcomes, communicate with clarity, and embrace innovation to make an impact. 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 (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
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. 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: Paid time off, 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, Massachusetts, Texas, Georgia, 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.
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
[email protected]. 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.
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 H-1B or F-1/OPT work authorization.