Sr. Business Analyst, Clinical Development

Job Title – Sr. Business Analyst, Clinical Development
 
Location – home-based, US – Remote

Duration – 6 months with potential for longer term and/or full-time
  
  • This position is remote, but candidates must reside in the US, be setup to work from home, and be willing to travel as needed (up to 25%).
 
Job Description:
Oracle is the leading provider of clinical trial operations software. Our market-leading SaaS-based products help pharmaceutical, biotech and medical device companies cut costs and dramatically accelerate the process of bringing new treatments to market.
Oracle ClearTrial is an integrated planning and forecasting Software-as-a-Service (SaaS) solution that employs sophisticated, rules-based algorithms wrapped in an elegant, easy-to-use, web-based user interface that enables rapid scenario planning of clinical studies and programs.
As a consultant for product strategy and management, you will utilize your industry expertise to analyze and communicate customer needs into product requirements. You will also evaluate existing system capabilities and work with clients and the industry to define product and clinical intelligence updates and enhancements.
Work is non-routine and complex, involving the application of advanced technical and business skills. This position will act independently as an individual contributor and as a team member. This role requires a critical thinker with strategic agility and strong verbal and written communication skills. BS/MS or equivalent experience and 5 years of pharmaceutical industry experience supporting clinical development is also required.

Responsibilities

This is an exciting opportunity to drive the design and development of innovative software products. You will decipher customer needs, translate needs into requirements, and define functional specifications for clinical software. You will work with life sciences industry experts and the software engineering team to transform complex needs into tangible solutions.

• Understand and document the business needs of customers
• Break high level requirements into thorough, detailed, user-focused specifications
• Facilitate the design and development of product features
• Interview subject matter experts, customers, and other stakeholders to identify and clarify requirements
• Use your own industry subject matter expertise to analyze and recommend updates to existing clinical intelligence
• Review the application's resource planning and level of effort costing rules and specify updates to remain current with industry standards
• Engage the ClearTrial customer community to understand, interpret, and document new product requirements and enhancements
• Communicate requirements and specifications to internal product management and development
• Provide guidance and recommendations on the strategic direction of the product

Qualifications-
 
 • 5+ years of business analyst experience working in an end-user environment within the pharmaceutical industry (e.g., pharma, biotech, device, CRO, and/or software vendor) 
 • Strong working knowledge of various clinical development functions (e.g., clinical operations, data management, biostatistics, outsourcing, etc.) 
 • Experience translating business issues into well-defined requirements and functional specifications 
 • Excellent analytical, listening, presentation, and communication skills 
 • Customer-facing experience
 • Entrepreneurial drive and ability to deliver results with limited supervision
 • Energetic, self-motivated, and assertive 
 • Bachelor’s Degree or equivalent
 
Additional Desired Skills/Experience
o Experience working closely with development and engineering teams through a product development lifecycle
o Experience with Agile development methodologies
o Experience creating wireframes/mock-ups
o Experience with clinical trial systems (CTMS, EDC, IRT, etc.) and processes
o Broad experience in both CRO and sponsor organizations
o Knowledge of clinical trial proposal processes and pricing methodologies
o Knowledge of clinical trial budget management and financial concepts (percent complete, revenue recognition methods, variance analysis, etc.)
o Hands-on experience with ClearTrial or other budgeting and forecasting software
 
Best,
Kushal Shah
APN Software Service INC
kushal@apninc.com
609-357-9180 (Direct)

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