Site Name: USA - Pennsylvania - Philadelphia Posted Date: Aug 20 2021 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. 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 If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. 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