Software Integrations Lead

Xtalks; Wellesley (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

4G Clinical is seeking an Integration Project Lead to guide client integration projects and ensure smooth implementation of Prancer RTSM/Admin systems. You will manage client engagement, project activities, and issue resolution while upholding high-quality standards.

Ideal candidates have 3+ years in clinical research or 7+ years in system implementations, with experience in RTSM/IRT, eClinical systems, and cross-functional project leadership.

Qualifications

• 3+ years in clinical research or 7+ years in system implementations.
• Experience with RTSM/IRT services delivery and eClinical systems.
• Project management with cross-functional teams.
• Knowledge of FDA GCP/21 CFR Part 11 is a plus.

Responsibilities

• Primary client engagement contact for Integration projects.
• Lead client meetings and requirements discussions with support from the Integrations Analyst.
• Ensure integration design is compatible with Prancer study design.
• Log, track, and drive resolution of functional and technical issues.
• Ensure adherence to SOP/WI deliverables and milestones.
• Drive study testing and UAT.

Skills

Client engagement

Project management

RTSM/IRT

eClinical systems

Systems integration

Education

Bachelor's degree

Tools

Prancer RTSM

Job description

Preferred Location is US EastJoin 4G Clinical as an Integration Project Lead and lead client integration projects, ensuring smooth implementation of our Prancer RTSM/Admin systems. This role involves client engagement, managing project activities, and resolving issues, all while maintaining high-quality standards. Ideal candidates have experience in clinical supplies operations, eClinical systems, and project management.

Description

Preferred Location is US EastJoin 4G Clinical as an Integration Project Lead and lead client integration projects, ensuring smooth implementation of our Prancer RTSM/Admin systems. This role involves client engagement, managing project activities, and resolving issues, all while maintaining high-quality standards. Ideal candidates have experience in clinical supplies operations, eClinical systems, and project management.

Key Accountabilities of the Integrations Project Lead include the following:

• Primary Client engagement contact for Integration projects
• Leading client meetings and requirements discussions with support from the Integrations Analyst
• Maintain knowledge of Prancer RTSM/Admin and serve as the SME ensuring integration design is compatible with Prancer study design
• Logs, tracks and drives resolution of functional and technical issues discovered during implementation and prior to go-live
• Ensures adherence to required deliverables and milestones as defined in applicable SOP/WIs
• Drives project activities, including study testing and UAT

Requirements

• The position requires a minimum of 3 years of experience in the clinical research field, particularly clinical supplies operations, RTSM/IRT services delivery and eClinical systems and integrations implementation, or over 7 years of relevant system implementation experience in related industry.
• Software implementation and testing experience required in clinical research or a 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.

Education And/or Certification Requirements

The candidate must possess at minimum a bachelor's degree in a life science, supply chain management, or information technology field, or equivalent experience.