Senior Manager, Clinical Analytical Systems

Job Summary

This is an exciting opportunity to partner alongside R&D Clinical business functions at Otsuka driving adoption of technology solutions and delivering measurable business outcomes. This business facing role involves business analysis, project management, demand management, vendor management, service management, developing roadmaps, establishing best practices and assessing new technologies.

Job Description

• The Senior Manager, Clinical Analytical Systems will engage and partner with cross functional business teams to gather business requirements, perform gap analysis, develop functional requirements, define solution recommendations, partner with internal and external development teams to execute the projects, lead UAT and provide operational support to current production systems.

• The role will have oversight responsibility of our vendor and MSP teams and will require leading Business Analysis and Project Management efforts. The candidate should possess in-depth expertise and experience implementing and hand on knowledge of products/solutions such as EDC/eSource, Clinical Data Hubs/ Data Warehouse, SAS, SDTM conversion tools, metadata repositories. The Senior Manager will collaborate closely with a number of Clinical Business Functions including Data Management, Clinical Programming, Biostatics functions to assess new initiatives and technologies, propose recommendations, and plan and execute related initiatives. The position will report to the Director, Clinical IT. This role will have end to end IT ownership (projects, enhancements and operations) across our clinical business functions

Core Responsibilities:

• Business Analysis: Lead the requirement gathering effort, analyze business needs, including decomposing abstract and complex details/concepts into business and functional requirements; develop business cases; evaluate and qualify opportunities. and defines measurable business outcomes. Identify opportunities for business process and technology improvements. Provides key insight toward development of multi-year strategic roadmaps.

• Subject Matter Expert:  Serve as a SME for assigned areas, understand business needs, maintain awareness of industry trends, and provide recommendations to facilitate decision making.

• Project Management:  Oversee multiple project deliveries with end-to-end responsibility throughout the project lifecycle, including risk management, defining project timelines, documentation, and providing status updates.

• Vendor Management:  Participate in vendor evaluations, selection, and management for assigned projects, working with the IT organization.

• Service Management: Provide oversight for the day-to-day operations of assigned area working with the support partners. Align with relevant IT teams to apply necessary incident and change management best practices and tools. Measure KPIs and drive teams to achieve operational excellence.

• Governance:  Build and maintain a project portfolio for assigned area.  Lead technology governance processes, working with cross functional stakeholders to gain alignment.  Drive prioritization of the backlog; shape and manage demand.  Coordinate closely with the IT Portfolio and Project Management Office.

Specific Job Responsibilities

• End-to-End IT ownership including projects, enhancements and operations of key areas and related business processes.

• Serve as IT point of contact for assigned areas. Lead demand management, estimation, prioritization, build, test, deployment and support for applications in scope.

• Evaluate, assess and qualify new demand in assigned areas. Shape demand by working with customers, vendor and technology partners. Propose technology solutions with cost and time estimates. Lead projects through review and approval process working with internal stakeholders.

• Assess and document technology roadmaps to align strategically with business and IT strategy.

Qualifications

Required

• Bachelor’s degree or equivalent.

• Minimum 8 years of relevant work experience.

• Experience with clinical systems across data management, clinical programming, biostatics – systems such as EDC/eSource, Clinical Data Hubs/ Data Warehouse, SAS, SDTM conversion tools, metadata repositories.

• Deep understanding of GxP / validation

• Project management and Vendor management experience.

• Strong analytical and problem-solving skills are required.

• Proficiency using collaboration tools, like Office 365 or similar

• Ability to communicate effectively with all levels of the organization.

• An understanding of systems development lifecycle and change management methodologies

• Strong negotiation and collaboration skills

• Strong relationship management skills.

• Up to 10% travel is required based upon business needs.

Preferred

• Experience in pharmaceutical industry

• Knowledge with Agile methodologies

• Experience with Office 365

• Understanding of databases, integration methods, APIs, and cloud hosting technologies like AWS is highly desirable

• Understanding of HIPAA, compliance, and privacy requirements for delivering projects in the healthcare industry

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer:  This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Statement Regarding Job Recruiting Fraud Scams

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