Urgent! IT Business Analyst (Clinical Data/GxP)- Remote then Cambridge

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Posted 6 days ago United States Salary undisclosed

Job Description

Kelly Services is seeking an IT BA PM for a multinational biotechnology company at Cambridge, MA. If this position may be interested to you, please email me back at (with your most up to date resume in word format) and advise the best time and number at which you can be reached Job Title Sr IT Business Analyst Project Manager Location Remote then Cambridge, MA Type Only W2 Assignment Length 6 months w possible extension Pay rate 75 - 80.73 per hour Call note ?Senior level BA ?clinical dev IT space, dealing with data sciences and clinical data all the way through to the analystics. ?two projects (SAS grid remediation) ?Would need to understand GXP validation ?Understand Nist security requirements ?Data privacy with remediation ?Help work on the project GXP system (clinical data) ?Arcade is the name of the project (clinical data hub) ?Understand these two applications where they need to see where the GAPs are where requirements are missing or testing is needed. ?They need to remediation and retirement ?Required to be onsite once everyone goes back ?Gxp is 100 required for the role ?Team structure but should work on own ?Extremely good communication skills ?SAS is in flight, the other project is soon (next 1-2 weeks) The RD 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. This role requires the following abilities bull High competency in system retirement and compliance remediation projects leverages BA tools and techniques bull Demonstrate traceable business and functional requirements (show work examples) bull Monitor, manage, and ensure predictable delivery of the project in a deadline-driven environment. bull Drive delivery and accountability of project peers and vendors bull Early identification and appropriate escalation of risks and issues that require assistance, attention, or executive resolution bull Effective communication of all project aspects to team and leadership, verbally or in written form The key activities for this position include bull Develop GxP-compliant SDLC deliverables bull Perform risk assessments bull Assist Test Lead validate functional requirements, where needed bull Co-develop IT Support documentation (System Management SOP Knowledge Base) bull Complete other ad hoc tasks, as requested bull Provide status reports Qualifications bull 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 bull 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 bull Excellent oral and written communication skills able to organize and clearly present ideas in a convincing and compelling manner bull Excellent interpersonal skills to gain understanding of requirements and priorities, manage stakeholder expectations, recognize non-communicated requirements and bring them to light bull Ability to operate effectively in a matrix environment team player yet able to work independently with minimal direction bull Familiarity with GxP, CFR 21 Part 11 and system validation bull Clinical Development - Biometrics and Data Management experience preferred. bull Knowledge 1. Minimum 5 years of experience in PharmaceuticalBiotech industry - Clinical Data Management and Biometrics business processes. SAS statistical programming knowledge is highly desirable. 2. SaaS vendors relationship with Biogen internal ADS group 3. Tools and Technology awareness desired SAS, Data Hub, electronic data archiving Education BA or BS in Biostatistics, Statistics or Computer Science required. Advanced degree is strongly preferred CBAP is strongly preferred. Thanks Soma Patanaik Professional Technical Recruiter Kelly Services, Inc Why Kelly Registered ? As a worker today, it's up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what's next is what we're all about. We know what's going on in the evolving world of work-just ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined. About Kelly Registered At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporarynontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. KellyGTS