Clinical Systems – Production Support Manager

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 a motivated and experienced application support manager.

Production support manager is the primary contact for end users of EDETEK software products. He/She will be managing a team of support analysts in the USA and Eastern Europe. Production support manager will coordinate work with application development, IT support and QA managers in the USA, Eastern Europe and China. The ideal candidate must possess good knowledge of clinical trials information flows and clinical applications.

MAJOR ACTIVITIES

  • Provide high quality support to users of EDETEK software products
  • Manage team of up to 5 support specialists (10+ in 2018/2019)
  • Assist users with application specific questions
  • Troubleshoot issues by accessing systems logs and data changes
  • Record and resolve issues in timely fashion
  • Clearly communicate business and technical requirements to internal staff
  • Review change requests for clarity, completeness and impact
  • Develop and document production support flows
  • Ensure compliance with internal policies and procedures

EXPERIENCE AND EDUCATION REQUIRED

  • 8+ years of hands-on experience in IT, application development and support
  • 3+ years of user-facing role and application troubleshooting
  • Previous management experience
  • Knowledge of drug development processes and methods
  • Ability to multi-task in a rapidly growing environment
  • Ability to learn and master new computer applications
  • Practical experience with Clinical SaaS platforms
  • Outstanding communication and presentation English skills
  • BS/BA in related disciplines

DESIRED MANAGEMENT, TECHNICAL SKILLS & EXPERIENCE

  • Knowledge of Clinical Data Standards (CDISC, HL7, etc.)
  • Experience and understanding of Cloud Computing and SaaS
  • Knowledge of GxP, 21 CFR Part 11 and HIPAA requirements
  • Understanding of programming languages and systems SAS, Java
  • Business and technical presentation skills and experience

WORK REQUIREMENTS

  • Being able to work in the corporate office (Princeton, NJ) and home office remotely
  • 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