Acceptance Testing, Agile Programming Methodologies, Analysis Skills, Biology, Biotech and Pharmaceutical, Bug Tracking/Defect Management, Business Analysis, Change Control, Clinical Data Management, Communication Skills, Dental Insurance, Documentation, Enterprise Applications, GxP, Pinnacle, Regulations, Regulatory Compliance, Regulatory Submissions, Requirements Management, Requirements Validation/Verification, Risk Analysis, Software Administration, Software Development Lifecycle (SDLC), Software Upgrades, Support Documentation, System Validation, Team Player, Test Plan/Schedule, Test Scenario, Testing, Traceability, Validation Documentation, Validation Plan, Validation Testing, Vendor/Supplier Evaluation, Vendor/Supplier Selection, Vision Plan, Waterfall Model of Software Development, Work From Home
Position: Business Analyst Pinnacle 21 Release
Location: Remote Work (Cambridge, MA)
Duration: 6+ Months
Seeking an experienced Business Analyst to support the upcoming Pinnacle 21 Enterprise release. The individual will be responsible for assessing new release functionality and vendor updates against existing business requirements, validated processes, and regulatory obligations. They will partner closely with business stakeholders, technical teams, Quality, and vendors to execute SDLC activities required for a GxP-regulated system.
The role will focus on requirements impact assessments, traceability, validation and testing support, documentation updates, and release readiness activities to ensure a compliant and successful deployment. Pinnacle 21 is a GxP-classified application supporting clinical data quality, CDISC compliance, and regulatory submission readiness.
Required Capabilities:
4+ years of Business Analyst experience supporting enterprise software implementations, upgrades, or releases.
Strong understanding of Software Development Lifecycle (SDLC) methodologies and deliverables.
Experience conducting requirements analysis, impact assessments, and gap assessments for software releases.
Experience supporting GxP-regulated systems within pharmaceutical, biotechnology, life sciences, or other regulated industries.
Ability to evaluate new vendor functionality against approved business requirements and identify required updates to documentation, processes, and testing.
Experience developing and maintaining requirements traceability.
Experience supporting User Acceptance Testing (UAT), including test scenario development, execution support, defect triage, and resolution tracking.
Strong documentation skills, including requirements, impact assessments, validation support documentation, and change control artifacts.
Ability to collaborate effectively with business SMEs, Quality, technical teams, and external vendors.
Strong analytical, communication, and stakeholder management skills.
Strongly Desired Capabilities:
Prior experience supporting Pinnacle 21 Enterprise or similar clinical data management, validation, or regulatory submission platforms.
Knowledge of Takeda computerized system validation (CSV) processes and GxP compliance requirements.
Experience supporting SaaS application releases and vendor-managed platforms.
Understanding of validation deliverables such as URS, requirements traceability, validation planning, risk assessments, and testing documentation. These are core SDLC artifacts referenced for GxP systems.
GxP/Pharma Experience: Preferred
Project Methodology: Agile & Waterfall
Benefits:
We offer a competitive compensation package that includes:
· [Pay Rate]: $60-80 per hour W2
o Note: Pay rate will be commensurate with experience.
· Medical for full time employees
· Dental, and Vision Insurance
· Life Insurance, Short-Term Disability, Long-Term Disability, etc.
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Alpha Business Solutions