Senior Technical Architect - Clinical Data Relevant Educational Qualifications Job2 months ago - Other categories - Houston - 83 views
Tired of working with old EDC technology? Looking for an opportunity to change how clinical trials, data and data are managed? Veeva's Vault CDMS Electronic Data Capture (EDC) application will truly change how the industry runs clinical trials and we want you on our team!
As a Senior Technical Architect, you will be a leading member of the Veeva Systems Professional CDMS Services group working on providing consulting and technical architecture design on project teams implementing Veeva Vault CDMS (EDC) to companies in the life sciences industry.
As a key member of our Professional Services team, the Senior Technical Architect will lead customer implementations by providing expertise with Technical architecture design, technical integration design, and Vault CDMS (EDC) best practices. The Senior Technical Architect is a customer advocate working closely with other Veeva teams (Product, Sales, Strategy) to ensure customer success today and in the future.
This is a work anywhere, full-time permanent role with Veeva. Our work processes are designed so that you can be productive in the environment that works best for you. This is a customer-facing role and we have no work location requirement if you are in close proximity to an airport and able to meet future travel requirements.
Veeva Systems does not anticipate providing sponsorship for employment visa status (e.g., H-1B, OPT) for this employment position.
What You'll Do
- Provide subject matter expertise on the Veeva Systems implementation, Vault CDMS (EDC) product suite, Vault Platform, technical design, and Software as a Service (SaaS) implementation best practices
- Design and implement cloud-based integrations
- Leading business process discovery and application design workshops
- Taking complex client and Technical concepts and articulating them to audiences of varying perception levels
- Design and provide subject matter expertise for development of custom applications
- Manage integration and development projects and resources
- Contribute to our professional services knowledge base
- Develop internal and external tools to help our customers and our consultants
- Partner with other parts of the organization to deliver technical presentations to current and prospective customers to evangelize the value of Veeva's Technical
- Support developers and testers during the project lifecycle
- Support the requirements gathering and specification creation process for all study integrations
- Support user acceptance testing with the customer for all custom integrations
- Create user acceptance testing scripts (if applicable) for all custom integrations
- Support go live activities for the study to ensure a smooth transition of the study to the customer
- Review requirements as part of the change management process and update specifications and configurations as necessary with associated scoping activities
- Act as the customers trusted advisor to ensure that the custom Technical is configured in such a way that it meets the customer's goals and offers the full benefits of Veeva's CDMS (EDC) application
- Notify project management of project risks and develop contingency plans as necessary
- Ensure customer success from beginning to end of the project life cycle
- Assure process compliance with all regulatory and Veeva procedural requirements
- Participate and contribute to process, product, or best practices initiatives
- Adherence to all Veeva and EDC Services procedures and policies
- 5+ years' direct experience working with EDC clinical software Technical in clinical operations, and/or trial management in a consultant role
- 5+ years' direct experience with integrations such as IVRS/IRT, Coding Labs, Imaging, eCOA/Pro, etc.
- 2+ years' experience in SAS/SDTM data extracts.
- 2+ years' experience in writing custom reports.
- Experience in interpreting clinical protocols and translating requirements into software specifications including writing and reviewing technical documentation
- Experience in a customer-facing role, preferably with a software professional services organization or consulting background is preferred
- Ability to quickly understand customer requirements and create corresponding Technical designs
- Ability to articulate integration design patterns
- Proven ability to manage diverse customers and/or stakeholders, and ensure delivery to a high degree of satisfaction
- Working Knowledge of Clinical Trial processes across pharmaceuticals, device and/or biotech sectors, specifically as they relate to design, document, and data collection
- Ability and willingness to "roll up your sleeves" to implement a clinical Technical
- Ability to quickly understand business requirements
- Proven ability to work independently in a dynamic, fast-moving environment, but also as part of a team
- Logical approach to problem solving
- Ability to manage multiple tasks and project deliverables
- Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and quality results
- Demonstrated success with customers during project assessment, planning, development, training and implementation.
- Excellent verbal and written communication, interpersonal, and presentation skills
- Expert on life sciences compliance and computer systems validation requirements
- Ability to travel 25-30% (may include international)
- 4-year college degree required
- Qualified candidates must be legally authorized to be employed in the United States. Veeva Systems does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Nice to Have
- Previous development experience with JAVA
- Experience with document management platforms
- Experience with GxP regulations and software validation process
- Experience with source code control systems
- Single Sign On experience
- Life sciences industry experience and knowledge of clinical trial process preferred (pharmaceutical, biotech, medical device companies, CRO's and academic & public health organizations).
- Direct experience with EDC systems such as Medidata RAVE or Oracle/Phase Forward InForm
- Experience working with system integrators for IVRS, medical coding, eSource, CTMS, eTMF, and other clinical technologies
- Life Science, computer science or related degree
- Familiarity with CDISC, ODM and other data management industry standards
- SaaS/Cloud experience in the delivery of clinical trials
- Enterprise experience and knowledge transfer for running clinical trials with EDC
- Consulting experience
Perks & Benefits
- Flexible PTO
- Allocations for continuous learning & development
- Health & wellness programs
This is a remote position. This is a work anywhere, full time permanent role with Veeva. Our work processes are designed so that you can be productive in the environment that works best for you. This is a customer facing role and we have no work location requirement if you are in close proximity to an airport and able to meet future travel requirements.
Veeva's headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.