Centralized Monitoring

2 weeks ago

Bengaluru Karnataka, India GSK Full time

**Site Name**: Bengaluru Luxor North Tower

**Posted Date**: May 14 2024

Would you like to be part of GSK’s emerging clinical leadership, with an opportunity to accelerate quality efforts across clinical operations on national and global scale? If so, this could be an excellent opportunity to explore.

As a Clinical Study Manager, you will be responsible for leading Global In-Country Clinical operations teams to improve quality processes and evolve the ways of working to optimise clinical operations and foster stronger quality relationships with the sites. You will also support the Director of Quality, Training and Capability Development with all required activities to achieve business goals.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following
- Lead and participate in cross functional teams to assess transformational initiatives and tools to help simplify ways of working and accelerate portfolio delivery
- Identify future capability and competency requirements in line with R&D strategy and the constantly changing and evolving internal and external environment
- Support capability development globally across the Local Operating Countries (LOCs) in partnership with the Regional Directors and LOC Clinical Operational Heads
- Sponsor and oversee the different communities across the Global In-Country Clinical Operations Team to ensure alignment between the communities and that the activities to bring simplification and value to the business
- Foster a culture of simplification, standardisation, sharing best practices, working across boundaries and continuous improvement through a variety of mechanisms
- Develop and drive the implementation of the risk register and management monitoring templates to each LOC and continuously look for opportunities to simplify and evolve management monitoring activities to the next level
- Conduct regular holistic quality discussions with the LOCs based on collective intelligence in partnership with the Regional Directors
- Partner with various business areas to analyse the global management monitoring output looking for local, regional, and global trends and share those learnings with the LOCs
- Support the Director of Quality, Training and Capability Development to build an effective Quality Management System (QMS) in partnership with other business areas
- Work with Clinical Quality Assurance (CQA) to support and where possible facilitate regulatory inspections, identify root causes for findings, and identify appropriate corrective and preventative actions; Ensure these learnings are shared with the business

**_Why you?_**

Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:

- Bachelor’s Degree
- 5 or more than years of experience developing quality programs for clinical operations
- Experience with Good Clinical Practices (GCP) and International Council for Harmonization (ICH) guidelines
- Experience working across geographies with clinical and corporate governance principals

Preferred Qualifications:
If you have the following characteristics, it would be a plus:

- Master’s Degree in science related field
- Advanced knowledge of the drug development processes and key operational interfaces
- Ability to plan, manage and lead cross-functional projects
- Excellent communication skills and able to explain complex situations

**_Why GSK? _**
- Our values and expectations are at the heart of everything we do and form an important part of our culture._
- 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

**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included.

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