Senior Business Analyst

CSG is seeking a Senior Business Analyst to participate in the lifecycle of Global Clinical Operations and Clinical Development technology solutions. The role involves defining business needs, project planning, vendor selection, and providing ongoing management for related systems while ensuring effective communication with stakeholders.

Responsibilities:

• Takes part in the lifecycle of Global Clinical Operations and Clinical Development technology solutions - defining business need, project planning, vendor selection, development, deployment, and end user adoption and provide ongoing management and functional operational oversight for all related systems
• Understands Clinical business areas, processes, and applicable regulatory environments. Hold in-depth and specialized knowledge in the core disciplines of Software Development Life Cycle (SDLC), project management, business analysis, and solution design/delivery
• Measures and communicates business value, e.g. improved efficiency
• Identifies and mitigates key cross-functional and vendor issues escalating to management as needed
• Excellent interpersonal skills, ability to develop relationships with key stakeholders, good conflict management and negotiation skills
• Exceptional written and verbal communication skills and ability to present in a clear and concise manner to audiences at all levels of an organization
• Strong analytical, quantitative, problem-solving and prioritization skills. Demonstrated ability to analyze complex issues, to develop relevant and realistic recommendations and plans, and meet multiple project deadlines while mitigating risks
• Proven ability to interpret internal and external customer needs
• High degree of motivation - results oriented
• Proven experience in Global Clinical Operations and/or Clinical Development and with business system requirements elicitation
• Knowledge and/or experience with broad array of Clinical systems including: elluminate, Clinical Trials Management System (CTMS), Risk Based Study Monitoring (RBSM), Electronic Trial Master File (eTMF), Clinical Trial Site Feasibility and Transparency, Safety Letter Distribution, Electronic Data Capture (EDC), Clinical Studies Operational Data Warehouse & Analytics, Site Portal Engagement/Training and Resource Management etc
• Significant experience in pharmaceutical/biotechnology and extensive knowledge of ICH-GCP guidelines, 21 CRF Part 11, and major Health Authority regulations as they pertain to the operational aspects of clinical studies
• Experience with Agile development and other program management methodologies (Waterfall, etc)
• Required proficiency:
• MS Office (Outlook, Word, Excel, PowerPoint, Visio)
• Advanced experience with MS Excel (formulas, pivot tables, graphical representations of data, etc)

Requirements:

• Takes part in the lifecycle of Global Clinical Operations and Clinical Development technology solutions - defining business need, project planning, vendor selection, development, deployment, and end user adoption and provide ongoing management and functional operational oversight for all related systems
• Understands Clinical business areas, processes, and applicable regulatory environments
• Hold in-depth and specialized knowledge in the core disciplines of Software Development Life Cycle (SDLC), project management, business analysis, and solution design/delivery
• Measures and communicates business value, e.g. improved efficiency
• Identifies and mitigates key cross-functional and vendor issues escalating to management as needed
• Excellent interpersonal skills, ability to develop relationships with key stakeholders, good conflict management and negotiation skills
• Exceptional written and verbal communication skills and ability to present in a clear and concise manner to audiences at all levels of an organization
• Strong analytical, quantitative, problem-solving and prioritization skills
• Demonstrated ability to analyze complex issues, to develop relevant and realistic recommendations and plans, and meet multiple project deadlines while mitigating risks
• Proven ability to interpret internal and external customer needs
• High degree of motivation - results oriented
• Proven experience in Global Clinical Operations and/or Clinical Development and with business system requirements elicitation
• Knowledge and/or experience with broad array of Clinical systems including: elluminate, Clinical Trials Management System (CTMS), Risk Based Study Monitoring (RBSM), Electronic Trial Master File (eTMF), Clinical Trial Site Feasibility and Transparency, Safety Letter Distribution, Electronic Data Capture (EDC), Clinical Studies Operational Data Warehouse & Analytics, Site Portal Engagement/Training and Resource Management etc
• Significant experience in pharmaceutical/biotechnology and extensive knowledge of ICH-GCP guidelines, 21 CRF Part 11, and major Health Authority regulations as they pertain to the operational aspects of clinical studies
• Experience with Agile development and other program management methodologies (Waterfall, etc)
• Required proficiency: MS Office (Outlook, Word, Excel, PowerPoint, Visio)
• Advanced experience with MS Excel (formulas, pivot tables, graphical representations of data, etc)
• B.A. / B.S. degree in computer science, scientific, or allied health field
• 5+ years of relevant work experience, preferably in an FDA GxP-regulated environment
• Experience with Veeva Vault platforms strongly preferred