• Us Citizen

• Green Card

• Corp-Corp

• Consulting/Contract

• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 1st Jul 2021

The Sr. IT Business Analyst for Research and Development (R & D) will support the Research and clinical development groups to analyze informatics needs, document gaps, propose solutions. The individual will be responsible for business analysis in R&D IT projects, and work closely with business users to support existing R&D informatics systems.

Essential Functions and Duties

• Review business process and data process, review informatics systems.

• Perform gap analysis, define future state process workflow and data flow

• Evaluate industry trends and vendors in R&D informatics domain

• Provide business analysis for new systems and services related to the functional and technical requirements in the areas of research, clinpharm, clinical operations, data management and biostatical analysis in accordance with the IT project lifecycle management framework, lead UAT testing in project

• Establish and maintain positive relationships with internal business partners

• Coordinate and collaborate with the infrastructure and security teams to ensure proper security, efficient utilization, allocation and user access

• Stay abreast of IT best practices around pharmaceutical and other industry technologies and their relevance to Akebia

• Assist in the writing and management of controlled processes around systems including validation, change control, electronic signature, and system-specific sysadmin documentation

• Develop and manage application training materials and support standards for the user community supported

• Work closely support team as second-line support for applications within R&D domain.

Skills and Experience

• Bachelor’s degree in life science or computer science is required; Master’s degree preferred

• At least 4-6 years of working experience with demonstrated success as a business analyst in the pharmaceutical or biotech industry

• Understanding of the pharmaceutical industry and its application environment needs including discovery, pre-clinical and clinical

• Working knowledge of the processes associated with Research, Clinical Development and Clinical Operations, working experience in the life science is a plus

• Knowledge of cGMP and validation requirements is highly desired

• Familiarity with clinical process and clinical systems such as electronic trial master file (eTMF), electronic data capture (EDC), clinical trial management system (CTMS), and statistical applications

• Familiar with research discovery process, and informatics tools such as ELN, Inventory management systems, LIMS, and research data analysis platforms

• Understanding of the relationship between applications, cloud-based technologies, SaaS applications, databases, operating systems, storage platforms, internet use and networks

• Experience in complete project lifecycle management including requirements gathering, stakeholder management, system and user documentation, application design, vendor selection and management, contract management, change management, deployment and training

• Strong analytical skills, able to translate complex process to simple requirement.

• Excellent communication and influencing skills, with demonstrated ability to work collaboratively and effectively across the organization

• Self-motivated, goal-driven, and high-performing team member