Senior Business Analyst - ClinicalApply Now
Location: Cambridge, Massachusetts 02142
Employment Type: Contract
Contract Length: 6+ months (likely to extend)
You will oversee Clinical Development projects supporting compliance remediations and system retirements. You’ll have a critical role in the health and success of projects within a matrixed organization and have direct relationships with various business and IT groups.
Keys to the Role
- High competency in system retirement and compliance remediation projects
- Demonstrate traceable business and functional requirements (show work examples)
- Monitor, manage, and ensure predictable delivery of the project in a deadline-driven environment.
- Early identification and appropriate escalation of risks and issues that require assistance, attention, or executive resolution
- Develop GxP-compliant SDLC deliverables
- Perform risk assessments
- Assist Test Lead validate functional requirements, where needed
- Co-develop IT Support documentation (System Management SOP; Knowledge Base)
- Provide status reports
What You’ll Bring
- 5+ experience as a Business Analyst, including in a GxP environment
- Knowledge of:
- System Validation
- NIST and Regulatory testing
- Data Privacy guidelines.
- CFR 21 Part 11
- Strong knowledge of SDLC
- Ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors
- Excellent interpersonal skills to gain understanding of requirements and priorities, manage stakeholder expectations, recognize non-communicated requirements and bring them to light
- Clinical Development - Biometrics and Data Management experience preferred.
- The following are a PLUS: SAS, Data Hub, electronic data archiving
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