Global Study Manager in Letchworth

Role Overview

The Global Study Manager (GSM - reporting into a Global Study Management Team Leader) delivers the clinical operation activities of the study / studies from CSI (Commit to Study Initiation) until study archiving. This involves generating robust and accelerated delivery plans to target or stretch thresholds and with quality.

This role is a great opportunity to be instrumental in developing and delivering GSK's R&D aims. As this role is multi-faceted and includes collaborating / liaising with a wide variety of stakeholders and matrix teams you must have strong experience of working in complex matrix-environment, with demonstrable clear problem-solving approach to your work. Strong people skills and a proven ability to influence people to achieve and drive performance are also pre-requisites for this role.

The GSM role works in consultation with the Global Study Lead (GSL) for end-to-end delivery of the clinical study. Please do not contact the recruiter directly. This job is with GSK, an inclusive employer and a member of myGwork - the largest global platform for the LGBTQ+ business community.

This role sits within Global Clinical Study Delivery (GCSD) as part of the Global Clinical Operations (GCO) function in GSK's Research & Development (R&D) division. GCO brings together Study Delivery Leadership and Study Management expertise into one organization (to deliver clinical studies consistently and efficiently for the organization).

Responsibilities

• Accountability for the deliverables (to be adjusted accordingly for the Study Team Operating Model (STOM) Full-Service Outsourcing (FSO) model (including Study Initiation Meeting, Activity & Delivery Plans, Vendors Oversight & Results Dissemination Plans, Recruitment & Budget tracking, Safety & Deviation management Plans, etc)).
• Supports assessment and selection of FSO vendors (and is accountable for oversight according to the FSO handbook).
• Responsible for assessment and selection of study vendors under GCSD responsibility (in consultation with Global Study Lead - GSL) and ensures compliance with ICH/GCP guidelines (including applicable laws and regulations, and SOPs for assigned studies).
• Proactively identifies, oversees, and mitigates study risks and ensures appropriate stakeholder communication (including study status, expectations, risks and issues).
• Acts as an ambassador for increased utilisation of Artificial Intelligence Machine Learning (AIML) tools, driving automation of manual processes, finding efficiencies and more effective ways of working.
• Acting as Working Group (WG) Lead for Clinical Operations for operational delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements, supporting decision-making (at pace) and leading study team to achieve overall study deliverables.

Qualifications

• Relevant degree-level education (eg; life sciences or related discipline).
• Relevant clinical research / study management and operations experience in a pharmaceutical/scientific environment (eg; Hands on experience across the study lifecycle: feasibility, start up/recruitment, vendor management and close out).
• Experience of working across multiple types of study designs, and in-depth knowledge of GCPs and ICH guidelines.
• Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available).
• Strong people skills and a proven ability to influence people to achieve and drive performance.

Skills

• Agile Thinking
• Business Acumen
• Clinical Development
• Clinical Research
• Clinical Sciences
• Clinical Trial Designs
• Communication
• Creativity
• Decision Making
• Fostering Collaboration
• Good Clinical Practice (GCP)
• Influencing Without Authority
• Pharmaceutical Industry
• Project Management
• Time Management

Company Culture and Values

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.

GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

Equal Opportunity Employer

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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