RTSM Solutions Architect — New Build Amendments

4G Clinical LLC.

Wellesley (MA)

Remote

USD 120,000 - 180,000

Full time

6 days ago
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Benefits offered by this job

Health, dental, and vision benefits
Unlimited Vacation Days for Salaried F
FSA and Dependent Care Accounts
Company Paid Disability and Life

Job summary

4G Clinical LLC. is seeking a Client Services Lead to drive system implementation and product development for RTSM/IRT solutions.

The role will oversee configuration changes to the PRANCER technology, manage project scope, and partner with Support, Validation, and Integration teams to ensure successful client deployments. The ideal candidate brings 5+ years in clinical research, a strong grasp of GCP/21 CFR Part 11, and experience delivering high-quality, validated deployments in a fast-paced

Qualifications

  • Minimum 5 years in clinical research, especially clinical supplies ops, RTSM/IRT services delivery
  • Knowledge of US FDA GCP and ICH GCP regulations, 21 CFR Part 11 and EU Annex 11 is essential

Responsibilities

  • Expert implementation of configurations to PRANCER technology.
  • Define and manage project scope with timelines and high quality deliverables.
  • Partner with Support Leads to manage client relationships and ensure successful implementations.
  • Provide change design consultation during discovery phase.
  • Coordinate validation with the Validation team to ensure thorough testing.
  • Work with Integration team to define and implement required changes.
  • Prepare technical environments for client use including UAT and production changes.
  • Identify opportunities for product enhancements with the Product Development team.

Skills

5+ years in clinical research
GCP knowledge
21 CFR Part 11
electronic records; electronic signatu

Education

Bachelor's degree in life sciences, supply chain, or IT

Tools

RTSM/IRT systems

Job description

4G Clinical LLC. is seeking a Client Services Lead to drive system implementation and product development for RTSM/IRT solutions.

The role will oversee configuration changes to the PRANCER technology, manage project scope, and partner with Support, Validation, and Integration teams to ensure successful client deployments. The ideal candidate brings 5+ years in clinical research, a strong grasp of GCP/21 CFR Part 11, and experience delivering high-quality, validated deployments in a fast-paced

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