Job Description
Job Description
Competencies:
• Knowledge of the systems used is required to efficiently complete tasks
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Ability to think flexibly in order to meet constantly shifting priorities and timelines.
• Interacts with customers to ensure compliance with systems requirements
• Excellent collaborative skills
Purpose-
This is an advanced-level analyst role within ISS for candidates with <8 years’ relevant experience. This role works in a matrix environment partnership with one or more cross-functional business groups to develop, standardize, improve & maintain business, technical & system functionality & processes to achieve the expected business benefits. Develop proficiency to serve as point of contact for questions related to assigned functional area(s) & Low-high risk systems for internal & external customers, as appropriate. Expected to develop skills as an internal expert in an assigned area or areas. Apply knowledge and experience in execution of job responsibilities.
Key Responsibilities:
1. Support, or act as, business system owner for clinical development systems and ensure that system is fit for purpose
2. Build working relationship with internal business, IT groups and external vendors.
3. Participate in and contribute to cross functional expert user groups
4. Ensure helpdesk support for system-related issues/queries and consistent, high-quality and timely resolution
5. Act as business escalation point in terms of major system issues and ensure that root cause analysis of major incidents is undertaken
6. Consistently coordinate and execute validation procedures and approve/sign off on qualification or validation documentation/system SOPs
7. Ensure that the system is kept audit-ready and is maintained in compliance with all legislative and regulatory requirements
8. Represent system in the event of an audit (internal or external), provide formal responses and ensure implementation of any corrective actions
9. Ensure data integrity is maintained and that all data integrity-related principals and policies are consistently applied and maintained
10. Oversee and engage users, stakeholders and other interfacing functional areas in the defining of user requirements and in user acceptance testing; ensuring that functionality and performance align to business need
11. Oversee release management including change control tracking and follow-up
12. Have knowledge of technical components of system and ability to apply that knowledge to the business need
13. Develop process documents with input from relevant stakeholders
14. Establish system governance for agreement & prioritization of goals, strategic planning and oversight of risk management
15. Ensure appropriate integration with other systems
16. Ensure user documentation for system (User Guide, User Training, Newsletters, Communications etc.)
17. Oversee standardization and dissemination of best practices across area
18. Participate on and contribute to team deliverables
19. Organize and schedule work to meet priorities and customer expectations
20. Involve with all business-related areas of the system development lifecycle for a system, including archival and decommissioning activities at the end of a system’s life.