Senior Product Development Specialist

Senior Product Development Specialist will participate in design and development of requirements, testing and pre-sales activities of EDETEK’s CONFORM™ product line. Sr. Product Development Specialist will be contributing to one or more than one component of the CONFORM platform. Daily activities will include interactions with the product leadership team, product owners, software engineers, business analysis and quality departments.

Senior Product Development Specialist must ensure that product functions operate in accordance with common CR&D business flows as well as industry regulations.

Senior Product Development Specialist contributes to the preparation of product demonstrations, meeting with customers and participation industry forums.

He/She must possess knowledge of clinical patient and operational information flows, as well as data management and analytical methods applicable to the conduct of clinical trials.

Essential Functions and Responsibilities 

• Consult with managers and business users to determine the role of CONFORM modules in clinical studies.
• Analyze quantitative and qualitative data to help in developing business solutions capable of fulfilling the needs of business users and improving the quality of service.
• Research edging clinical analytics technique and provide detailed information to senior technical and management personnel if any technology can increase the CONFORM’s efficiency and effectiveness.
• Work with other team members to implement emerging business intelligence tool to reduce the operational cost in clinical field by defining KPIs, reports, and dashboards.
• Integrate CONFORM platform with other software under guidance of senior technical personnel from both data and security perspective.
• Assist to apply automation of CONFORM procedures by translating the manual business process into automated processes.
• Devise ways to add new functionality to existing software products with assistance from senior product analytics personnel.
• Draft use cases for CONFORM’s data-driven strategies, collect required resources for analysis and build tentative data models.
• Design and develop new systems under guidance of senior product analytics personnel by choosing and configuring hardware and software.
• Assist the installation and configuration of new systems to customize them for the organization.
• Conduct manual system testing and develop an automated script to ensure that the systems work as expected.
• Assist with UAT, developing and maintaining quality procedures, and ensure that appropriate documentation is in place.
• Assist/guide the system’s end users about major functionalities of existing product and write instruction manuals supporting both internal and external training program.
• Annotated CRF, converted clinical study datasets conform with SDTM standards, and prepared corresponding documentation.
• Performed production and QC programming of analysis datasets, table listings, figure, and patient profile for clinical trials.
• Trained employees in internal SAS macro utility and associated CONFORM tools; provided CDSIC related consulting service for major clients.
• Leaded several full submission deliverable projects and supported sponsors with multiple ongoing studies regular data update.

• 8+ years of hands-on experience in pharmaceutical clinical business and clinical information technology
• Knowledge of CR&D processes and methods
• Demonstrated work experience as a business user and/or clinical business technologist in one or multiple clinical processes and applications (i.e. data collection, trial management and operations, data standardization, data transformation, data warehousing, analytics)
• 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, biology, life sciences or relevant field
• Some travel (5%) may be required with a potential of travel occurring over weekends

DESIRED TECHNICAL SKILLS & EXPERIENCE

• Innovative business application mindset with great attention to detail
• Knowledge of Clinical Data Standards
• Familiarity with Cloud Computing
• Understanding of AI/ML algorithms
• Ability to write analytical and database programs (SQL, Python, SAS, etc)
• Understanding of software product development and SDLC
• Strong organizational and presentation skills

Benefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees.

• Choice of comprehensive Medical, Vision and Dental Insurance plans
• Paid vacation time and sick days
• Corporate holidays annually
• Participation in the 401K Plan
• Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc.
• Health Advocate and Employee Assistance Program

Location

This is a remote position, and we are open to candidates based in the United States.

Equal Opportunity Employer Statement 

EDETEK is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Whenever possible, the company makes reasonable accommodations for qualified individuals with disabilities to the extent required by law.