Business Analyst w/ GxP& SAS
The R&D IT Senior Business Analyst (BA) will oversee Clinical Development projects supporting compliance remediations and system retirements. The BA plays a key role in the health and success of projects within a matrixed organization. Has direct relationships with various business and IT groups.
location: , 0
job type: Contract
salary: $60 - 65 per hour
work hours: 9am to 5pm
- 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)
- Complete other ad hoc tasks, as requested
- Provide status reports
- Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors
- 5-7 years' experience as a Sr. Business Analyst, with working command of GxP, System Validation, NIST and Regulatory testing, and Data Privacy guidelines. Highly experienced in SDLC
- Excellent oral and written communication skills; able to organize and clearly present ideas in a convincing and compelling manner
- Excellent interpersonal skills to gain understanding of requirements and priorities, manage stakeholder expectations, recognize non-communicated requirements and bring them to light
- Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction
- Familiarity with GxP, CFR 21 Part 11 and system validation
- Clinical Development - Biometrics and Data Management experience preferred.
1. Minimum 5 years of experience in Pharmaceutical/Biotech industry - Clinical Data Management and Biometrics business processes. SAS statistical programming knowledge is highly desirable.
2. SaaS vendors; relationship with internal ADS group
3. Tools and Technology awareness desired: SAS, Data Hub, electronic data archiving
skills: - High competency in system retirement and compliance remediation projects; leverages BA tools and techniques
- Demonstrate traceable business and functional requirements (show work examples)
- Monitor, manage, and ensure predictable delivery of the project in a deadline-driven environment.
- Drive delivery and accountability of project peers and vendors
- Early identification and appropriate escalation of risks and issues that require assistance, attention, or executive resolution
- Effective communication of all project aspects to team and leadership, verbally or in written form
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.