Sr. Analyst, Clinical Development

Title: Senior Analyst, Clinical Development

 Location – Remote or from Chicago, IL, 60606

 Contract duration – 6 months with potential for longer term and/or full-time

 Travel required – up to 30%

 There was no specifically matching job title in Oracle's system, so I added the title into the description. This title is most similar to the type of position we are seeking. Please note that a location was selected only based on the majority of the team's location, but this position can work anywhere in the US, remotely.
 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. With immense pressure on biopharma companies to increase productivity, reduce costs and compress cycle times in drug development, our innovative software has been rapidly adopted by our blue chip customers, including 7 of the top 10 global biopharma companies in the world. 
 Join a team of experienced professionals working in a fast-paced culture where each member has significant autonomy and responsibility. We value innovative thinking, elegant and pragmatic design, exceptional team chemistry, and an innate passion to make an impact.
 •       Act as the chief clinical subject matter expert 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.
 •       7+ years’ experience in clinical outsourcing, financial planning, and/or clinical project or program management, with strong experience in the following areas:
        o        Actively negotiating clinical CRO bids
        o        Constructing or analyzing clinical budget proposals
        o        Building and managing costing models
        o        Reviewing Request for Proposals (RFPs), CRO bids, and protocols to identify specifications that impact cost and strategy
 •       3+ years as a clinical trial finance, program, or project manager for a biotech/pharmaceutical company or CRO
 •       Strong analytical 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 with clinical trial systems (CTMS, EDC, IRT, etc.) and processes
        o        Broad experience in both CRO and sponsor clinical operations
        o        PMP certification
        o        Business analysis
        o        Hands-on experience with ClearTrial or other budgeting and forecasting software
 Detailed Description:
 As a consultant for product strategy and management, you will utilize your industry expertise to analyze and communicate external customer needs into product requirements. 
You will 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 very complex, involving the application of advanced technical and business skills. 
This position will act independently as an individual contributor and as a team member, providing guidance and mentoring to others. This role requires a critical thinker with strategic agility, financial modeling expertise, strong business acumen and organizational prowess.  
BS or MS degree or equivalent experience relevant to functional area. 7 years of pharmaceutical industry contracting, business planning, budgeting or related experience required.
Kushal Shah
APN Software Service INC

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