Note: The job is a remote job and is open to candidates in USA. 4G Clinical is a global leader in cloud-based randomization and trial supply management software for the life sciences industry. The RTSM Technical Project Manager - Level I supports system implementations, configuration changes, validation, testing, integrations, and client user acceptance activities, while also assisting with operational support and audits.
Responsibilities
- Partnering closely with project leads in support of the implementation of configuration changes and to enable client start-up targets to 4G Clinical’s PRANCER technology
- Attend client meetings and design sessions as appropriate
- Support logging, tracking and resolution of functional and technical issues discovered during implementation and prior to applying changes to production
- Reviews and understands change impacts and risks with project leads to focus project testing efforts accordingly
- Ensures adherence to required deliverables and milestones of Project Management SOP
- Drive project specific validation activities including Build Verification Testing, Validation Testing, system setup and implementation activities
- Supports project validation activities including testing, setup, and implementation activities
- Develops and executes scripts for testing
- Supports changes to integrations, including implementing changes to integration specifications
- Assist with client user acceptance testing (UAT) activities
- Serve as Customer Support point of escalation for any system or support issues where required; assist with creation of training materials
- Maintain issue logs for builds or validation activities of the RTSM
- Participate in client audits as needed
Skills
- 1-3 years of experience in the clinical research field
- RTSM/IRT services delivery and eClinical systems implementation
- Software implementation and testing experience required in clinical research or supply chain related industry
- Project management experience working with cross-functional business and technical teams as project lead is required
- The candidate must possess at minimum a bachelor's degree in a life science, supply chain management, or information technology field, or equivalent experience
- Knowledge of US FDA Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) GCP regulations, Electronic Records; Electronic Signatures regulation (21 CFR Part 11) and EU Annex 11 is a plus
Benefits
- For U.S.-based candidates: Health, dental, and vision benefits
- For U.S.-based Salaried Full-time Employees: Unlimited Vacation Days
- For U.S.-based candidates: FSA and Dependent Care Accounts
- For U.S.-based candidates: Company Paid Disability and Life Insurance
- For U.S.-based candidates: Global mental health benefit
- For U.S.-based candidates: Generous 401k program
- For U.S.-based candidates: Paid sabbatical program
- For U.S.-based candidates: Option Grants
Company Overview
Company H1B Sponsorship