Oracle Life Sciences Hub Solution Architect
About The Position
7-10+ Years in the Clinical Data Domain. Must have worked at a pharma company - ideally "big" pharma OR could have come from Big 5 consulting exclusively focused in the Clinical Data Domain Deep understanding of clinical data including data constructs and data models for pre-clinical, clinical, and post clinical data. This means they can explain the types of data captured throughout the R&D value chain, the relationships between these data elements, and how such data is typically modeled (ideally within Oracle Life Sciences Hub) Deep understanding of the analysis and reporting needs within the clinical domain space. This means understanding the common consumers of various reports, the timing of consumption, and the data elements you may find within these reports. It also means a functional understanding of the common reporting technology including Oracle OBIEE and/or Oracle's Clinical Development Analytics. SAS reporting, while different and more technically focused on Bio-statistical reporting is also a plus here. Good understanding of the FDA submission process including how the data must be aggregated and presented to the FDA. This may include SDTM Modeling (Standard Data Tabulation Modeling) Deep functional understanding of Oracle Life Sciences Hub and must have deployed it at least twice OR thoroughly led a long term (5+ yr) implementation at Big Pharma (or in the context of consulting) Other clinical data product technology could be beneficial (but Oracle LSH is a must) Ideal candidate has completed at minimum 2 OLSH engagements - preferably at the senior level, must be hands on not just the project manager Ideal candidate should also be very familiar and have responsiblity with Sales activities - we are expecting that they have managed sales initatives that have generated 3 to 5 million in sales Ideal candidate is still hands on and involved in managing the engagement, helping to guide the client and also establishing best practices with the practice This resource must be functional and be willing to travel 100%, possibly even internationally Excellent communication skills a must
Requirements
- 7-10+ Years in the Clinical Data Domain
- Must have worked at a pharma company - ideally "big" pharma OR could have come from Big 5 consulting exclusively focused in the Clinical Data Domain
- Deep understanding of clinical data including data constructs and data models for pre-clinical, clinical, and post clinical data
- Deep understanding of the analysis and reporting needs within the clinical domain space
- Good understanding of the FDA submission process including how the data must be aggregated and presented to the FDA. This may include SDTM Modeling (Standard Data Tabulation Modeling)
- Deep functional understanding of Oracle Life Sciences Hub and must have deployed it at least twice OR thoroughly led a long term (5+ yr) implementation at Big Pharma (or in the context of consulting)
- Functional Oracle Life Sciences Hub experience
- Clinical Data Domain experience
- Good understanding of the FDA Submission process
- Willingness to Travel - Always
- Excellent communication skills a must
Nice To Haves
- SAS reporting, while different and more technically focused on Bio-statistical reporting is also a plus here.
- Other clinical data product technology could be beneficial (but Oracle LSH is a must)
- Clinical Development Analytics experience
- Ideal candidate has completed at minimum 2 OLSH engagements - preferably at the senior level, must be hands on not just the project manager
- Ideal candidate should also be very familiar and have responsiblity with Sales activities - we are expecting that they have managed sales initatives that have generated 3 to 5 million in sales
- Ideal candidate is still hands on and involved in managing the engagement, helping to guide the client and also establishing best practices with the practice
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
