Clinical Solution Architect

JOB DESCRIPTION
EDETEK is building a comprehensive set of technologies to greatly improve management of processes and information in Pharmaceutical Clinical R&D. We are an industry leader offering a comprehensive clinical informatics platform CONFORM™ to numerous large and small biopharmaceutical companies and CROs.

We are looking for highly motivated and experienced clinical business technology visionaries that have a passion for development of innovative industry leading processes and systems to improve and further differentiate our products.

Solution Architect will be responsible for conceptual design as well as business, regulatory and technical requirements definitions of EDETEK products. The ideal candidate must possess expert-level knowledge of clinical patient and operational information flows. He/She must be skilled in current and future technologies applicable to clinical trials.

Solution Architect will be the ultimate resident expert of multiple EDETEK products. He/She will be guiding and collaborating with the architecture and product engineering teams internally while facing EDETEK’s customers externally. Solution Architect will drive and balance product innovation and practical design specifications. He/She will provide business and technological ideas based on market needs, make recommendations for product’s road map to improve usability, performance and level of services.

MAJOR ACTIVITIES

  • Develop product strategy in one or more than one clinical application areas
  • Lead design of new solution concepts leveraging existing and/or future platform components
  • Collaborate with product management, business analysts, subject matter experts and product engineering to develop functional and business requirements for new applications
  • Clearly translate business and technical requirements to the analysts, engineers and QA specialists
  • Assess complexity, cost and timing of new solutions from business and technology perspectives
  • Develop and document process and information flows
  • Develop specifications for information integration within EDETEK CONFORM™ applications, and up and down stream external systems
  • Prepare and participate in customer demonstrations and proof of concepts
  • Lead and/or participate in RFP/RFI writing and bid defenses as a solution expert
  • Prepare and participate in industry forums and conferences
  • Participate in solution implementation, if required
  • Participate in corporate audits, if required

EXPERIENCE AND EDUCATION REQUIRED

  • 10+ years of hands-on experience in pharmaceutical clinical business or information technology
  • Expert knowledge of CR&D processes and methods
  • Demonstrated experience as a leader and solution architect in multiple clinical processes and applications (i.e. data collection, trial management and operations, data standardization, data transformation, data warehousing, analytics)
  • Practical experience with Clinical SaaS platforms
  • Excellent knowledge of clinical systems and vendors commonly used in the industry
  • Understanding of quality and information privacy requirements applicable to clinical systems
  • Outstanding communication and presentation abilities
  • BS/BA in computer science, engineering, mathematics, business, life sciences or relevant field, MS/MBA preferred

DESIRED MANAGEMENT, TECHNICAL SKILLS & EXPERIENCE

  • Knowledge of Clinical Data Standards (CDISC, HL7, etc.)
  • Demonstrated experience and understanding of Cloud Computing
  • Understanding of event driven processes and technologies
  • Practical experience or good understanding of data modeling
  • Knowledge of GxP, 21 CFR Part 11 and HIPAA requirements
  • Understanding of product development and SDLC
  • Understanding of architectural patterns to support horizontally scalable applications
  • Visionary business and technical mindset with great attention to detail
  • High quality organizational and leadership skills
  • Business and technical presentation skills and experience

WORK REQUIREMENTS

  • Being able to work in the corporate office (Princeton, NJ) and home office remotely
  • The ideal candidate must reside within one-hour commute distance from Princeton, NJ. Remote locations may be considered
  • Availability in early and late hours to participate in scheduled global online meetings over the Internet/Skype
  • Cross-functional and client interactions
  • USA Residents or Citizens only

TRAINING

  • Complete Training Requirements per current Training Requirements List