G1 Therapeutics
  • Durham, NC, USA
  • Full Time

G1 Therapeutics is seeking an experienced IT Senior Solutions Architect to join the IT team.

Responsibilities:

 Application Development, Implementation and Support

  • Provide technical and project management expertise to design, implement and support key information systems for regulated processes for G1's Clinical and Regulatory teams
  • 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 G1 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 G1 security and compliance requirements and standards.
  • Develop and document DR strategies for delivered systems and services.

 

Project Management

  • 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.

 

Strategy and Governance

  • 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, eTMF, 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 G1 IT Steering Committee as required to help document, plan and prioritize project work.

Requirements:

  • BA/BS degree or equivalent required, advance degree is preferred
  • 8 years experience successfully developing, implementing, and supporting information systems and services in FDA regulated environment
  • 3 years experience in deployment and support of cloud-based SaaS systems and services is preferred
  • 3 years experience in SaaS vendor management is preferred
  • A broad knowledge of clinical and regulatory business processes and technologies
  • Experience with life science information systems and services from Oracle and Veeva is preferred
  • Demonstrated experience in key compliance areas such as GxP, HIPAA, SOX, Sunshine Act, EU Data Protection and other compliance driven requirements
  • Demonstrated experience delivering technical solutions with validation, documentation, training and support in a FDA regulated environment
  • In depth knowledge of software development tools, practices, and lifecycle methodologies
  • Experience with the use of SDLC methodologies in project delivery
  • Demonstrated experience planning, coordinating, and executing multiple projects concurrently
  • Demonstrated experience with application development tools including Oracle, MS SQL, JavaScript, .Net Framework
  • Demonstrated experience with BI analytics tools and reporting applications
  •  Strong analytical and problem-solving skills
  • Superior organization, planning, and project management skills
  • Excellent interpersonal, communication, and business partnering skills
  • Ability to drive continuous improvement across the organization
  • Ability to facilitate and resolve conflicts at both the senior and staff level
  • Ability to operate in a cross-functional / matrixed environment

G1 Therapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. G1 Therapeutics complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

G1 Therapeutics
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