IT R&D Business Solutions Manager
IT R&D BUSINESS SOLUTIONS MANAGER
Global Blood Therapeutics (GBT) is seeking an IT Research and Development (R&D) Business Solutions Manager to partner with GBT’s business units in the development and execution of a systems roadmap that supports our continued growth. This position will play a critical role in leading and implementing critical business systems as GBT approaches commercialization.
The position will encompass varying responsibilities including project management, requirements/process definition, and change management. The IT R&D Business Solutions Manager will be expected to have an understanding of the overall clinical development process, including the flow of data between systems at various stages of trial conduct.
The successful candidate must have strong project and program management experience and know-how to plan, execute, and deliver a wide range of projects from complex cross-functional system implementation projects to upgrades and enhancements. This individual must be an excellent communicator and capable of interfacing and influencing people within all levels of the organization.
Essential Duties and Responsibilities:
- Act as an IT subject matter expert in understanding the “big picture” of pharmaceutical development and how the related systems fit together
- Assist in building the IT strategy and roadmap for assigned business units and for assisting business units in developing business cases for IT governance prioritization
- Lead and manage cross-functional clinical systems projects in partnership with stakeholders in R&D
- Develop understanding and documentation of clinical business processes, data, and systems. Identify gaps where system investments could make a meaningful impact
- Partner with business process owners and business leaders to evaluate and identify process improvement opportunities
- Meet with business leads on a regular basis to collect potential projects. Budget or forecast financial needs to implement projects
- Conduct analysis of features and changes, determine their impact, and inform business partners
- Create, develop, and document detailed support plans, and maintain runbooks for common issues for the support team to troubleshoot and resolve basic end-user requests
- Prepare and present written and oral reports containing detailed findings and recommendations to present project status, improve services and operations, and changes in business partner prioritization
- Work with user and development groups to identify and document system recommendations for current and future development. Work with users to refine process and procedural guidelines
- Help to streamline and/or optimize business processes with appropriate IT tools
- Encourage system adoption and provide tier 2-3 support if/when needed
- Bachelor's degree from four-year college or university and 8 years of experience, preferably in R&D in the life sciences industry
- Strong IT project management experience; PMP certification a plus
- Ability to manage many competing priorities from various departments
- Extensive experience in both structured and agile SDLC methodologies as well as computer systems validation (CSV) processes. Instills an agile and continuous improvement culture
- Demonstrated experience as a business and/or functional analyst, particularly in definition of business requirements, process design/documentation, and change management
- Strong understanding of clinical systems and processes, from trial start to regulatory submission
- Must have strong business and data analysis skills and be ability to understand complex business processes to develop agile and insightful data-rich solutions
- Solid understanding of cloud infrastructure technologies and SaaS
- Experience implementing and managing ongoing operations of systems including user support, run books, system enhancements, and upgrades
- Thorough knowledge of GxP regulations related to CSV including 21 CFR Part 11 and GAMP standards
- Proficient with Microsoft Project or Smartsheet, Office and Visio
- Excellent organizational and follow-up skills with strong attention to detail
- Must possess excellent communication (oral and written) and problem-solving skills
Fit with GBT culture:
- Ability to build strong relationships with co-workers of various backgrounds and expertise
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
- Values-based leadership consistent with GBT's Core Values
- Excitement about the vision and mission of GBT
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.