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Clinical Systems Manager

Novartis


Location:
Cambridge, Massachusetts
Date:
05/10/2017
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Clinical Operations
Novartis
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Job Details

 

               

Job Description

Novartis is undertaking a strategic project, referred to as STRIDE, to replace several core systems used to execute drug development across its divisions including Portfolio/Project Management (PPM) and Clinical Trial Management (CTMS) applications. This position will play a central role in supporting NIBR Clinical Science & Innovation (CS&I) participation in this project. These applications are used by CS&I and broader organization to centrally plan and track schedules, resources, and external costs related to clinical studies at trial, disease area, and portfolio levels. Data in the applications populates a suite of centralized management reports (as well as enabling ad hoc analyses) which are used to inform tollgate approvals by applicable governance boards, highlight and mitigate risks, inform decision making, and enable benchmarking and performance improvement over time.

 

1. Project Planning, Management, and Oversight: Take lead role in developing project plans and managing timelines to ensure NIBR Clinical contribution to STRIDE timelines and milestones are met. Coordinate agenda and minutes for team meetings. Assist with development of management presentations to highlight scope, timeline, risks and mitigation steps related to major releases as well as outlook for future application roadmap. 2. System Specifications: Responsible for coordination of NIBR “sub-team” meetings to collect and document requirements from system users and other key stakeholders. Translate requirements into use cases that describe how the functionality will be used on a daily basis within the organization. Actively participate in and/or lead workshops designed to align on and document application requirements. 3. Process Flows: In parallel with developing system specifications, determine how deployment of system functionality impacts existing business processes including timing and quality of key data inputs and outputs as well as roles and responsibilities for execution of major tasks in the system. 4. System Design & Configuration: Interface with technical development team to ensure that specifications are documented at appropriate levels of detail and understood. Clarify any ambiguous requirements with users on behalf of technical team and reflect refinements in documentation. Assist in coordinating review/testing of any initial prototypes. Document feedback on prototypes vs requirements as applicable. 5. System Testing and Release: Provide input to testing plan to ensure that applications are functioning according to documented system specifications including “scripts” or scenarios for users to test. Document whether application meets desired requirements or not including explanation and prioritization of any gaps. Align with management team on clear go/no go criteria for system release to production.

 

 

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

 

 

Minimum requirements

Bachelor degree or equivalent education/degree in business, mgmt information systems, or science/healthcare field is required. Advanced degree in mgmt information systems or applicable preferred. Fluent English (oral and written) 1. 5+ years’ experience in pharmaceutical indus- try, such as in Clinical Development, Finance or Project Management or similar length of experience working within consulting industry supporting systems and process design/re-engineering. 2. Knowledge of and experience within various aspects of system design lifecycle including requirements gathering/system specifications, system design & configuration, testing, training, and system administration. 3. Knowledge of and experience using portfolio and project management (PMP) software to plan and manage schedules, resources, and costs across a portfolio of projects. 4. Strong verbal and written communication skills 5. Great attention to accuracy and detail. 6. Excellent planning and organizational skills 7. Ability to work independently, but also to manage a team comprised of internal and external participants globally.