Senior Product Development Specialist - Clinical Business
New
E
EDETEKPharmaceutical Clinical
United StatesFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 8+ years
- Required Skills
- PythonSQLCloud Computing
Requirements
- 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
- Knowledge of clinical patient and operational information flows, as well as data management and analytical methods applicable to the conduct of clinical trials.
- 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
Responsibilities
- Participate in design and development of requirements, testing and pre-sales activities of EDETEK’s CONFORM™ product line.
- Contribute to one or more than one component of the CONFORM platform.
- Ensure that product functions operate in accordance with common CR&D business flows as well as industry regulations.
- Contribute to the preparation of product demonstrations, meeting with customers and participation industry forums.
- 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.
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