Global Study Management Associate Director

1 week ago


Mississauga, Canada GlaxoSmithKline Full time

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

As a Clinical Support Manager, you will be responsible for supporting 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 put together to assess transformational initiatives/ tools to help simplify ways of working and accelerate portfolio delivery

- Identify future capability and competency requirements in line with the R&D strategy and the constantly changing and evolving internal and external environment

- Supports capability development globally across the Local Operating Companies (LOCs) in partnership with the Regional Directors and LOC Clinical Operational Heads

- Sponsor and oversee communities across the Global In-Country Clinical Operations Team to ensure alignment between the communities and that the activities 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 launch of risk register and management monitoring templates to each LOC and have regular holistic quality discussions with the LOCs based on collective intelligence in partnership with the Regional Directors

- Partners with different business areas to analyse the global management monitoring output looking for local, regional, and global trends and share learnings with the LOCs

- Supports the Director of Quality, Training and Capability Development to build an effective Quality Management System (QMS) in partnership with other business areas

- Works with Clinical Quality Assurance (CQA) to support and facilitate regulatory inspections, identify root causes for findings and appropriate corrective and preventative actions

- Leads Global In-Country Clinical operations teams put together to improve processes, quality, and evolve ways of working to optimise clinical operations and foster stronger quality relationships with sites

**_Why you? _**:
**Basic Qualifications**:
We are looking for professionals with these required skills to achieve our goals:

- Bachelor’s degree
- 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 a 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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

**Important notice to Employment businesses/ Agencies



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