IT Project Manager

Insight Global; Groton (CT); On-site; USD 110,000 - 170,000; Full time

Job summary

Insight Global is seeking a Software Development Project Manager / Business Analyst to support a global pharmaceutical client within their External Development and Manufacturing Solutions group. This role will lead end-to-end delivery of enterprise software initiatives across drug development, manufacturing, insourcing, and outsourcing operations.

This role bridges business stakeholders and technical teams, owning requirements, solution design, project execution, implementation, training, and

Qualifications

• Bachelor's degree in a related field (CS/IT/Life Sciences/Pharmacy/Engineering)
• 5+ years of experience in software development project management
• Experience in a GxP environment
• Hands-on experience with SQL-based relational databases in a PM/BA capacity

Responsibilities

• Lead software development projects through the full SDLC in a GxP-regulated, validated environment
• Define and manage scope, timelines, budgets, risks, resources, and deliverables
• Facilitate Agile/Scrum ceremonies like sprint planning, standups, retrospectives, and reviews
• Collaborate with R&D, Manufacturing, Regulatory, Quality, Medical Affairs, and Commercial teams
• Maintain project documentation including charters, status reports, roadmaps, requirements docs, and validation artifacts
• Elicit and validate business and functional requirements (BRDs, FRDs, user stories, use cases)
• Translate pharmaceutical needs into actionable technical specs for .NET teams
• Support regulatory compliance and validation activities related to GxP and 21 CFR Part 11
• Coordinate UAT planning, execution, and business sign-off
• Develop training materials, user guides, and change management plans
• Lead readiness, go-live planning, data migration, cutover, and hypercare support
• Monitor post-launch KPIs and system performance

Skills

Project management

Business analysis

Agile methodologies

Education

Bachelor's degree in Computer Science/IT/Engineering or related field

Tools

SQL databases

Job description

• Bachelor's degree in Computer Science, Information Technology, Life Sciences, Pharmacy, Engineering, or related field required
• 5+ years of experience in software development project management
• experience working in a GxP environment
• Hands-on experience with SQL-based relational databases in a project management or BA capacity

Job Description

Insight Global is seeking a Software Development Project Manager / Business Analyst to support a global pharmaceutical client within their External Development and Manufacturing Solutions group. This individual will lead the end-to-end delivery of enterprise software initiatives supporting critical business functions across drug development, manufacturing, insourcing, and outsourcing operations.

This role will serve as the bridge between business stakeholders and technical teams, owning requirements gathering, solution design, project execution, implementation, training, and post-launch support. The ideal candidate will bring a strong blend of project management, business analysis, technical understanding, and experience working in GxP-regulated, validated systems environments.

Responsibilities:

- Lead software development projects through the full SDLC within a GxP-regulated and validated systems environment.

- Define and manage project scope, timelines, budgets, risks, resources, and deliverables.

- Facilitate Agile/Scrum ceremonies including sprint planning, standups, retrospectives, and reviews.

- Partner with cross-functional stakeholders across R&D, Manufacturing, Regulatory, Quality, Medical Affairs, and Commercial teams.

- Maintain key project documentation including charters, status reports, roadmaps, requirements documentation, and validation artifacts.

- Elicit, document, and validate business and functional requirements, including BRDs, FRDs, user stories, use cases, process flows, and acceptance criteria.

- Translate complex pharmaceutical business needs into actionable technical specifications for .NET development teams.

- Support regulatory compliance and validation activities related to GxP, 21 CFR Part 11, validated systems, and applicable quality processes.

- Coordinate UAT planning, execution, and formal business sign-off.

- Develop training materials, user guides, job aids, and change management plans to support global adoption.

- Lead implementation readiness, go-live planning, data migration coordination, cutover planning, and hypercare support.

- Monitor post-launch KPIs, adoption metrics, system performance, and continuous improvement opportunities.