R&D Business Systems Lead (BSA/PM) with Life Sciences -GxP Expereince

Hi ,

This is Sagar from KSource Inc. We have an excellent job opportunity for you below is the JD please have a look.

Job Title: R&D Business Systems Lead (BSA/PM)

Location: Cambridge, MA (Remote)

Duration: 12+ months

Qualifications & Experience

Required:

• 8+ years of combined experience in Life Sciences IT, including:
• Minimum 4 years in a GxP-regulated system administrator or support capacity.
• Minimum 4 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.

Tools/Platforms (preferred):

• Veeva Vault (Clinical, Regulatory, eTMF)
• Medidata Clinical Cloud (EDC, RTSM)
• ArisG or similar safety systems
• JIRA, Smartsheet, or similar PM tools

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.

1. 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.

1. 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.

1. 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.

Thanks & Regards,