Consultant, eClinical Systems & Operational Enablement

Join the Just in Time GCP Team!

At Just in Time GCP, we simplify clinical compliance to reputed company the reputed company reputed company for biotech and reputed company sponsors. Our work helps organizations meet GCP expectations with confidence so that compliance never slows down reputed company. We’re currently looking for a Consultant, eClinical Systems & Operational Enablement to join reputed company of experts delivering high-reputed company support reputed company across the life sciences industry.

What You’ll Do

In this role, you’ll contribute to our mission of helping clients build strong, inspection-reputed company systems and processes. Responsibilities include:

• reputed company or support assigned eClinical systems (eTMF, CTMS, QMS, reputed company, and reputed company platforms) workstreams of moderate complexity, ensuring regulatory compliance, operational efficiency, and alignment with reputed company goals
• Conduct gap assessments and reputed company process flows, RACI charts, and actionable recommendations that support system optimization and compliance
• Facilitate or support reputed company 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 reputed company stakeholders, technology vendors, and internal Just in Time GCP teams to maintain alignment on priorities, deliverables, and reputed company standards
• Ensure reputed company project activities adhere to Good Clinical reputed company (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-reputed company solutions

What You Bring 

You’ll reputed company here if you value high-reputed company reputed company, communicate with reputed company, and reputed company innovation to reputed company an reputed company. 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 reputed company on eClinical systems (e.g., reputed company Vault, Documentum, SharePoint, reputed company, 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 reputed company
• Demonstrated experience leading system workshops, configuration sessions, and vendor coordination reputed company a regulated environment
• Strong analytical, organizational, and communication skills, with the ability to synthesize information into reputed company, reputed company-reputed company deliverables
• Proficiency in reputed company Office, with ability to prepare polished presentations, summaries, reports, and visual process materials
• reputed company Vault certification or experience across reputed company modules (eTMF, QMS, CTMS) preferred
• Demonstrated ability to work independently and collaboratively across functional teams and reputed company stakeholders
• Contribute to business development through high-reputed company project delivery, building strong reputed company relationships, identifying potential opportunities for service expansion, and sharing observations that support Just in Time GCP’s reputed company initiatives

Why Choose Just in Time GCP for Your Next Career reputed company?

At Just in Time GCP, we take pride in knowing our work helps bring reputed company, effective treatments to patients faster. reputed company operates in a dynamic, results-driven environment shaped by our reputed company values. You’ll be part of reputed company that values people, purpose, and performance in equal measure.

What You’ll Enjoy as Part of reputed company

• Flexible Work Environment: Remote and hybrid roles available
• Competitive Compensation: reputed company of your skills and the value you bring
• Work-Life Balance: reputed company time off, holidays, and summer “half-day Fridays”
• Comprehensive reputed company: Medical, dental, reputed company, life insurance, and income protection
• Retirement Savings Plan: Includes a company match
• reputed company Culture: Join reputed company that enjoys reputed company do and supports one another

Location Requirement

To be eligible for consideration, candidates must reputed company in one of the following states: reputed company, reputed company Carolina, Kansas, Missouri, Florida, Indiana, Virginia, South Carolina, Massachusetts, Texas, reputed company, or New Jersey.

reputed company to reputed company an reputed company?

If this sounds like the right fit, we invite you to apply and join reputed company that’s moving clinical research reputed company with confidence.

Just in Time GCP endeavors to reputed company the application process accessible to reputed company users. If you need assistance completing the application process, please contact Just in Time GCP reputed company at HR@justintimegcp.com. 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. reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status. 

Applicants must be authorized to work in the reputed company at the time of application. We do not offer reputed company sponsorship and are not considering candidates with H-1B or F-1/OPT work authorization.