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 motivated and experienced clinical data standards solution consultants for multiple roles, both internal and external facing.
Clinical Data Standards Solution Consultants help define product requirements and support our clients and prospective clients using our portfolio of technology solutions. EDETEK Solution Consultants require practical experience in Clinical Data Standards, eSubmissions and the flow of data throughout the Clinical Data Lifecycle. The ideal candidates must also possess a practical knowledge of the implementation of data standards (CDISC, HL7, etc.).
- Establish and drive client implementations of EDETEK’s industry leading platform (CONFORM™) to manage global data standards and processes.
- Provide product training and guidance to EDETEK clients and prospective clients.
- Provide data standards and eSubmission expertise to EDETEK clients and facilitate data standards strategies and best practices.
- Lead and contribute to multiple components of EDETEK’s CONFORM™ platform development, definition, validation and support in collaboration with internal and external stakeholders.
- Translate market feedback into solution requirements and contribute to business case documentation.
- Develop and maintain business documentation including business rules and guidelines where applicable.
- Monitor relevant data standards and health authority guidances and their impact on solution sets.
- As a member of the EDETEK team, participate in industry working groups (e.g. PhUSE, CDISC) to provide thought leadership in clinical data standards arena.
- Collaborate with marketing and sales team to create content (white papers, industry presentations, webinars, etc.) and design solution demonstrations that articulate the value of EDETEK solutions to the marketplace.
- Ensure compliance with internal policies and procedures.
EXPERIENCE AND EDUCATION REQUIRED
- 8+ years of experience supporting clinical trials and data standardization across multiple therapeutic areas.
- Practical experience in the implementation of data standards (CDISC) and the change management processes required for successful implementation.
- Practical knowledge of metadata tracking, storage and use in clinical trial systems and processes, including analysis and reporting.
- Energy, enthusiasm and interest in delivering solutions that change data into assets.
- Ability to multi-task in a rapidly growing environment.
- Ability to learn and master new computer applications.
- Outstanding communication and presentation English skills.
- BS/BA in related disciplines.
DESIRED MANAGEMNT, TECHNICAL SKILLS & EXPERIENCE
- Understanding of programming languages (e.g.SAS, R) and commonly used technologies.
- Knowledge of and participation in Clinical Data Standards (CDISC, PhUSE, HL7, etc.).
- Experience and understanding of Cloud Computing and SaaS.
- Knowledge of GxP, 21 CFR Part 11 and HIPAA requirements.
- Strong business and technical presentation skills and experience.
- Ability to work in the corporate office (Princeton, NJ) and/or a home office remotely.
- Ability to support cross-functional and client interactions.
- Ability to travel for client interactions and industry events.
- USA Residents or Citizens only.
- Complete Training Requirements per current Training Requirements List