Sr. Business Analyst with Pharma Experience :: (Need Experience in Clinical Trail or Clinical Trail Management and GXP) :: NJ (Remote)

Hi,      
Hope you are doing great!!      
Please go through the below job description and let me know your thoughts. 
 
Title: Sr. Business Analyst  
Location: NJ (Remote) 
MOI: Phone and Skype 
 

• Operational systems used in clinical research: CTMS (Oracle Siebel preferred), TMF, Site/study monitoring systems 
• Clinical data systems (EDC, data management/reporting systems) and industry standards (CDISC-SDTM) 
• Leading detailed requirements gathering, analysis and documentation activities; ability to translate requirements to technical/development teams 
• Working in integration (ETL) development projects and conducting data scoping/mapping activities 
• Leading and contributing to SDLC artifacts, specifically for validated (GxP) systems 
• Experience preparing and facilitating UAT activities 
• Good business acumen, communication and facilitation skills 
• Clinical Trials Operations experience must have 
• Risk Monitoring – Issue control, risk mitigation, deviation detections, etc. 
• Pharma - GxP experience needed 
• SDLC experience in an agile environment 
• Data integration experience nice-to-have 
• Elicit requirements using interviews, document analysis, requirements workshops, surveys, site visits, business process descriptions, use cases, scenarios, business analysis, task and workflow analysis. 
• Critically evaluate information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, abstract up from low-level information to a general understanding, and distinguish user requests from the underlying true needs. 
• Proactively communicate and collaborate with the business to analyze information needs and functional requirements and deliver artifacts as needed, such as Business Requirements Documents and Use Cases. 
• Experience in using enterprise-wide requirements definition and management systems and methodologies are required. 
• Successfully engage in multiple initiatives simultaneously 
• Work independently with users to define concepts and under direction of project managers 
• Drive and challenge business units on their assumptions of how they will successfully execute their plans 
• Strong analytical skills required, including a thorough understanding of how to interpret business needs and translate them into application and operational requirements. 
• Serves as the conduit between the internal customer community and the software development team through which requirements flow. 
• Develop requirements specifications according to standard templates, using natural language. 
• Collaborate with developers and subject matter experts to establish the technical vision and analyze tradeoffs between usability and performance needs 
• Be the liaison between the business units, technology teams and support teams 

Remarks: 
1. Clinical Trials Experience
2. Pharma GxP
3. Data Integration experience

Client Domain: R&D Clinical 
 

Regards,
 
Shivam Dwivedi
Cybertec, Inc.,
11710 Plaza America Drive
Suite #2000, Reston, VA 20190
Direct: (732) 436-3439
Fax: 703-871-5291
Email: shivam@cy-tec.com
URL: www.cy-tec.com

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