- 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

Job Related Experience:

- 3 to 8 years of experience

- 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

- Nice To Have

Familiarity with supporting the below from a validation and operational support perspective:

- InForm EDC (Electronic Data Capture)

- Oracle Health Central Designer

- Medidata Rave EDC

- SQL and DataSets

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

- Operating at pace and agile decision-making using evidence and applying judgement to balance pace, rigour and risk.

- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

- Continuously looking for opportunities to learn, build skills and share learning..

Sustaining energy and well-being.

- Building strong relationships and collaboration, honest and open conversations.

- Budgeting and cost-consciousness.

Note: For your candidature to be considered on this job, you need to apply necessarily on the redirected career page of the company as well.

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.