Associate Director - Global Study Lead

The Global Study Lead will lead the planning and delivery of a global clinical study and work with cross-functional teams across clinical development, data management, safety, regulatory and external partners. We value clear decision-making, practical problem solving and a collaborative approach. This role offers visible impact, strong learning opportunities and the chance to help deliver work that advances GSK’s mission of uniting science, technology and talent to get ahead of disease together.

Key Responsibilities:

• Provide oversight and support to the appropriate teams on end-to-end clinical study delivery.
• Serves as the point of escalation for Clinical Operations.
• Ensure compliance with ICH [International Council for Harmonisation] /GCP [Good Clinical Practice] guidelines, all applicable laws and regulations, and GSK SOPs [Standard Operating Procedure] for assigned studies. understand study contribution to program/submission.
•  Accountable for translating asset requirements to the study and appropriate communication with the Clinical Operations Asset Lead
•  Balance risk/benefit to make decisions based on clear understanding of impact on the study and project.
• As the SLT [Senior Leadership Team] escalation point for clinical operations, support the Working Groups leads to proactively and effectively identify, oversee, and mitigate study risks.
• Ensure appropriate stakeholder communication, including study status, expectations, risks and issues.
•  Ensure robustness in upfront feasibility and planning
•  Preparation of materials for governance and / or financial review cycles.
•  Effectively build and lead empowered matrix teams.
• Provide strategic oversight on operational input into protocol and informed consent form development, and other key study documents.
• Oversee quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies.
• Lead / contribute to ways of working and process improvement initiatives.
•  Leads assessment and selection of FSO [Full-Service Outsourcing] vendors in collaboration with COAL [Clinical Operations Asset Lead] and be an escalation point for vendor issues.
• Ambassadors in increasing utilisation of AIML [Artificial Intelligence & Machine Learning] tools, driving automation of manual processes, finding efficiencies and more effective ways of working.

Skills

Agile Thinking, Clinical Operations, Clinical Studies, Clinical Trial Designs, Clinical Trials, Communication, Decision Making, Fostering Collaboration, Influencing Without Authority, People Management, Pharmaceutical Industry, Project Management, Risk Management, Stakeholder Management

 

 

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.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at [email protected] to discuss your needs.

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