Clinical Systems Associate Job in Cambridge 02139, Maine US
Infinity is an innovative drug discovery and development company seeking to discover, develop, and deliver to patient’s best-in-class medicines for difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Infinity is a small but fully integrated drug discovery company with capabilities ranging from early discovery to clinical sciences. Through a series of strategic alliances, Infinity is in a position to independently fund the development and commercialization of its drug candidates.
Responsibilities:
- Provide support to Data Management, Statistics and Clinical Operations functions including:
- Assist in the identification of gaps in process or technology and potential solutions to fill these gaps
- Gather and manage user requirements to enable the development and implementation of Commercial Off The Shelf (COTS) or internally-built software solutions
- Develop and report data analysis via (tables, listings, and graphic visualizations) to support customer requests
- Create and maintain user documentation and training materials in support of data warehousing and other technologies, as needed
- Integrate data from a variety of enterprise systems including Electronic Data Capture (EDC), external data sources (e.g., Interactive Voice Response (IVRS), ECG, laboratory data), Clinical Trial Management Systems (CTMS), Data Warehouses and SharePoint.
- Management of validated systems and compliance with associated SOPs and best practices (e.g. system validation support, change control, etc.)
- Mapping raw data into an internal data warehouse using data standardization procedures (e.g., SDTM)
- Documentation of conventions and practices used by Clinical Systems
Requirements:
- BS or equivalent with at least 3 years of professional experience with an understanding of clinical trials and data warehousing strategies
- Working knowledge of relational databases and data structures
- Programming experience such as SQL, C Sharp, Python
- Experience with Business Intelligence software such as Spotfire, Business Objects or similar
- Desire to learn and advance career in biotechnology industry or related field
- Highly organized, proactive and self-motivated
- Good written and verbal communication skills
- Strong sense of customer service and able to follow-up on multiple issues simultaneously
- Demonstrated ability to work as part of a team
Additional skills appreciated, but not required:
· Knowledge of 21CRF Part 11
· Prior exposure to Clinical trials
· Data warehousing experience
· CDISC (SDTM) experience
· Knowledge of SDLC
For consideration, please apply on our website: http://www.infi.com/careers-opportunities.asp
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