Business Analyst w/ GxP& SAS

  • location: Cambridge, MA
  • type: Contract
  • salary: $60 - $65 per hour
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job description

Business Analyst w/ GxP& SAS

job summary:
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
education: Bachelors
- 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.

- Knowledge:

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.

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