Job Role: Business Analyst with Project Management (BA/PM)

Location: Cambridge MA - Remote

Mode: Long Term Project

Job Required:

We need emphasize on Gxp, CRO, Biotech, change requests, requirement traceability matirx, decommisioning applications, small projects , vendor management and stake holder management.
10+ years of combined experience in Life Sciences IT, including:
Minimum 5 years in a GxP-regulated system administrator or support capacity.
Minimum 5 years in project management, delivering cross-functional systems in R&D or Clinical domains.
Strong working knowledge of clinical trial operations, safety, regulatory workflows, and associated SaaS platforms.
Demonstrated application of GAMP 5, 21 CFR Part 11, CSV principles, and QMS processes.
Familiarity with managed service or FSP support models.

Education:

Bachelor’s Degree in Life Sciences, Computer Science, Pharmacy, or a related field is plus.

Tools/Platforms (preferred):

Core Responsibilities:

1. Strategic Systems Planning and Project Leadership

Lead end-to-end delivery of R&D-focused technology initiatives aligned with the MRI IT Roadmap and scientific portfolio.
Define business requirements through interviews, workshops, and process mapping.
Develop and manage project plans, RAID logs, timelines, and communication cadences with leadership and stakeholders.
Facilitate system design reviews, UAT coordination, go-live readiness, and change management across departments.

2. GxP Systems Operations and Compliance Oversight

Administer and support validated GxP systems including Veeva Vault (Clinical, Regulatory), Medidata EDC, ArisG Safety, SAS, and future platforms.
Perform system configuration, user access management, audit trail review, and routine periodic review attestations.
Manage change requests, deviations, CAPAs, and quality event documentation in compliance with 21 CFR Part 11 and GAMP 5.
Interface with managed service providers and CROs to coordinate issue resolution and ensure systems remain inspection-ready.

3. Stakeholder & Vendor Management

Act as the bridge between MRI’s scientific and operational stakeholders, external vendors, and the IT organization.
Support business process owners with vendor onboarding, contract alignment, service-level tracking, and compliance assurance.
Participate in vendor performance reviews and support FSP models where system stewardship is distributed.

4. Knowledge Management & Enablement

Create and maintain user guides, SOPs, work instructions, and training resources.
Serve as the primary contact for user onboarding, technical guidance, and data integrity practices for supported systems.

Business Analyst

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