4G ClinicalRemote
RTSM Technical Project Manager - Level I
United States of America
Full Time
1 hour ago
H1B Sponsor Likely
Key skills
RTSMIRT services deliveryeClinical systems implementationSoftware implementationSoftware testingClinical researchSupply chain industryUS FDA Good Clinical Practice (GCP)International Conference on Harmonization (ICH) GCP regulationsElectronic RecordsElectronic Signatures regulation (21 CFR Part 11)EU Annex 11Project managementGCPProject Management
About this role
4G Clinical is a global leader in randomization and trial supply management software for the life sciences industry. The RTSM Technical Project Manager will support the implementation and operations of the PRANCER technology, ensuring adherence to project deliverables and assisting with client user acceptance testing.
Responsibilities:
- Partnering closely with project leads in support of the implementation of configuration changes 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
- Supports project validation activities including testing, setup, and implementation activities
- 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
Requirements:
- 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
- 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
- The candidate must possess at minimum a bachelor's degree in a life science, supply chain management, or information technology field, or equivalent experience