Principal Product Management, Clinical Solutions
Location:
Bedford , Massachusetts
Posted:
February 08, 2017
Reference:
160014VJ
Principal Product Manager
Oracle Health Science Global Business Group
Bedford, MA

Oracle ClearTrial is the leading provider of clinical trial operations software. Our market-leading Software as a Service (SaaS)-based products help pharmaceutical, biotech and medical device companies cut cost and dramatically accelerate the process of bringing new treatments to market.

Oracle ClearTrial is an integrated planning and forecasting, software as a service, that employs sophisticated rules-based algorithms, wrapped in an elegant, easy-to-use web-based system to enable 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 rapidly been adopted by our blue chip customers, including Abbott Vascular, Astellas, Gilead, Regeneron, Takeda, GSK, Genentech, Merck, Roche, Sanofi-Aventis and 7 of the top 10 biotech companies in the world.

Your teammates are exceptionally bright, talented, and experienced professionals working in a fast-paced culture where every team member has significant autonomy and responsibility. We value innovative thinking, elegant and pragmatic design, exceptional team chemistry, and innate passion to make an impact.

• Act as the clinical Subject Matter Expert to assist in product development enhancements, updates or improvements.

• Algorithm owner to manage and maintain the application's 900 resource planning and level of effort costing algorithms to remain current with industry standards.

• Fluently understands the components of a clinical study, the relationships between those activities and be able to interpret and communicate such information to internal product development and the broader ClearTrial customer community.

• Clinical expert across major clinical functional and/or therapeutic area indications for industry best practices and new product requirements.

• 8 years experience in clinical outsourcing and clinical project 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 project manager for a biotech, pharmaceutical company.

• Very strong analytical skills

• Customer facing

• Strong project management background

• Entrepreneurial drive and ability to deliver results with limited supervision

• High energy, self-motivated, assertive; consummate professional

• Bachelors Degree or equivalent

Additional Capabilities/Experience Desired

• Experience with clinical trial systems (CTMS, EDC, IVR, etc.) and clinical trial processes

• PMP certification

• Broad experience in both CRO and sponsor clinical operations
Qualifications:
Lead a team that acts as the central resource and driving force for the design, process, manufacturing, test, quality and marketing of product(s) as they move from conception to distribution. Organize interdepartmental activities ensuring completion of the project/product on schedule and within budget.

As a member of the product development division, you will analyze and integrate external customer specifications. Suggest and justify product directions and specifications. Specify, design and implement moderate changes to existing software architecture. Build new products and development tools. Build and execute unit tests and unit test plans. Review integration and regression test plans created by QA. Communicate with QA and porting engineering to discuss major changes to functionality.

Work is non-routine and very complex, involving the application of advanced technical/business skills in area of specialization. Leading contributor individually and as a team member, providing direction and mentoring to others. BS or MS degree or equivalent experience relevant to functional area. 7 years of software engineering or related experience.

Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans status or any other characteristic protected by law.

A little about us:
Oracle is shifting the complexity from IT, moving it out of the enterprise by engineering hardware and software to work together—in the cloud.

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