Global Study Manager

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).Job-purpose:

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.  The GSM role works in consultation with the Global Study Lead (GSL) for end-to-end delivery of the clinical study.

Responsibilities (include..,):

Acting as Working Group (WG) Lead for Clinical Operations, for the 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

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.

Please Note

- Location:

The successful applicant can be based at GSK HQ (London) or at Stevenage (Hertfordshire).  If the successful applicant is based at Stevenage site:  This role will temporarily be based at Stevenage.  However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge UK, in accordance with timelines to be set by the Company.  

The relocation is currently proposed to take effect by early 2029.

About You:

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.

About GSK:

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. 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…