4G Clinical · 5 hours ago
RTSM Solutions Architect - New Builds/Amendments
Portland, OR
Full-time
Onsite
Senior Level
5+ years exp4G Clinical is a global leader in randomization and trial supply management, offering innovative solutions for the life sciences industry. The Client Services Lead, Amendments will be responsible for implementing system changes, managing client relationships, and ensuring successful project implementation.
Health CareManagement Information SystemsPharmaceuticalSoftware
Responsibilities
Expert implementation of configuration changes to 4G Clinical’s PRANCER technology, including:
Primary responsibility for defining and managing project scope and implementing technical changes within agreed timelines and at the highest quality
Partner with 4G Clinical Support Leads to manage the client relationship and ensure successful project implementation
Provide change design consultation assistance to 4G Clinical Support Leads during ‘discovery’ phase, prior to formal project request or start-up
Partner with 4G Clinical Validation team to complete project validation, ensuring study changes are fully tested, and related risk areas are regression tested
Partner with 4G Clinical Integration team to ensure that required integration changes are correctly defined, tested and implemented
Escalate mid-project scope changes to 4G Clinical Accounts team to ensure that associated client costs are appropriately assessed and managed
Prepare all technical environments for internal and client use, including client UAT and production change implementation
Ensure that required patient data changes in support of the system changes are defined, scripted and tested
Identify opportunities for product enhancements and collaborate with product development to influence RTSM product feature development, prioritization, and strategy to ensure that the product meets client capability needs, improve the system’s efficiency and user-friendliness
Qualification
Required
A minimum of 5 years (10 for senior) of experience in the clinical research field, particularly clinical supplies operations, RTSM/IRT services delivery and eClinical systems implementation is preferred
Knowledge of US FDA Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) GCP regulations
Knowledge of Electronic Records; Electronic Signatures regulation (21 CFR Part 11) and EU Annex 11 and associated regulatory guidance documents
The candidate should possess at minimum a bachelor's degree in a life sciences, supply chain management, or information technology field, or have equivalent experience
Benefits
Health, dental, and vision benefits
Unlimited Vacation Days for Salaried Full-time Employees
FSA and Dependent Care Accounts
Company Paid Disability and Life Insurance
Global mental health benefit
Generous 401k program
Paid sabbatical program
Option Grants
Company
4G Clinical
4G Clinical provides software and services for clinical drug trials specifically in randomization and trial supply management (RTSM).
201-500 employees
H1B Sponsorship
4G Clinical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2022 (3)
2021 (3)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$252.12MKey Investors
Goldman Sachs Asset ManagementSchooner Capital
2021-06-29Series Unknown· $230M
2019-12-30Series Unknown· $14.62M
2016-10-19Series A· $5M
Leadership Team
David Kelleher
Founder and CEO
Ed Tourtellotte
Founder and Board Director
Recent News
2024-04-14
Company data provided by crunchbase