SalaryUSD TBD TBD
VDart – We are a Global Information Technology Services & Workforce Solutions firm headquartered out of Atlanta, GA with presence in US, Canada, MX, UK, Belgium, Japan & India. Founded in 2007, Our team of over 2550+ professionals continually create impact for our customers worldwide in solving complex technology challenges with cutting edge technologies. We specialize in providing the Fortune 1000 companies, niche hard to find skills in technologies including Social, Mobile, Big Data Analytics, Data Sciences, Cyber Security, IoT, Cloud, Machine Learning, and Artificial Intelligence. With delivery centers in the UK, Mexico, Canada, and India, we provide global workforce solutions to our customers covering EMEA, APAC & Americas. VDart is an award-winning organization recognized by Inc 5000 Hall of Fame; Atlanta Business Chronicles Fastest Growing Companies; NMSDCs National Supplier of the Year; Ernst & Youngs Regional Entrepreneur of the Year and more. Title: Senior Solutions Architect (Clinical and Regulatory) Location: Research Triangle Park, NC (Remote: Yes, until COVID ends) Hire Type: Contract Skills: Clinical, Regulatory, PV, eTMF, CTMS Primary Job Responsibilities:
- Application Development, Implementation and Support
- Provide technical and project management expertise to design, implement and support key information systems for regulated processes for Client Clinical and Regulatory teams including PV, eTMF, CTMS
- In partnership with key vendors, provide operational support and system administration for implemented systems and services.
- Manage application vendors according to negotiated contracts and documented support SLAs. Perform performance assessments and establish a review process of issues.
- Work closely with the Client IT team to help define the company's application architecture that will facilitate efficient implementation and integration of "best-in-class" SaaS business systems and services.
- Develop approach and implement technical solutions to address the aggregation, analysis, and reporting of data from independent data systems and services.
- Provide consulting and technical leadership in identifying and implementing new information systems and services.
- Provide technical guidance to other personnel.
- Ensure all work meets Client security and compliance requirements and standards.
- Develop and document DR strategies for delivered systems and services.
- Act as an IT liaison and project manager between the business areas and IT partner to manage project formation, functional requirements, technical specifications, project deliverables and acceptance criteria, vendor selection, resource management, project milestone review, development, testing, validation, training, documentation, implementation, and support.
- Coordinate activities across multiple projects, products, and technologies to ensure integration, consistent implementation, and compliance with technical standards.
- Establish configuration standards and ensures project documentation requirements are met.
- Partner with senior IT and business leaders to better understand the needs of the business, and work to ensure that resources and projects are properly aligned with business priorities.
- Direct the planning and coordination of key business initiatives (i.e., Document Management, Quality Management, CTMS, eTMF, PV, PV ESG, Pharmacovigilance, Regulatory Submissions).
- Assist in the assessment, selection and management of systems and services vendors. Help negotiate vendor contracts and establish vendor SLAs.
- Assist management in budgeting for implementation and operation of applications and services.
- Review status of business applications and prepare recommendations for system improvements.
- Monitor and manage the application projects and report on the status.
- Develop and document financial business cases for planned projects. Participate in Client IT Steering Committee as required to help document, plan and prioritize project work.
- Help establish and maintain effective governance for IT controls.
- Assist in regulatory inspections. Represent application design, functionality and technical controls during regulatory audits if needed.
- Author technical documents, including SOPs, validation documents, RFP's, white papers, strategy documents, monthly reports, status reports, and user manuals as may be required.
- Other duties as assigned.