At a Glance
- Tasks: Lead clinical studies from initiation to completion, ensuring quality and timely delivery.
- Company: Join GSK, a global biopharma leader dedicated to improving health worldwide.
- Benefits: Enjoy competitive pay, flexible working options, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on innovation and patient care.
- Why this job: Make a real impact on global health while working with cutting-edge technology.
- Qualifications: Degree in life sciences and experience in clinical research or study management.
The predicted salary is between 44595 - 54505 £ per year.
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.
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:
- 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 and leading study team to achieve overall study deliverables.
- Accountability for the deliverables according to the Study Team Operating Model (STOM) Full-Service Outsourcing (FSO) model.
- 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 and ensures compliance with ICH/GCP guidelines.
- Proactively identifies, oversees, and mitigates study risks and ensures appropriate stakeholder communication.
- 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.
Location: The successful applicant can be based at GSK HQ (London) or at Stevenage (Hertfordshire). If based at Stevenage site, this role will temporarily be based there but will subsequently change to Cambridge UK, in accordance with timelines set by the Company.
About You: This role is a great opportunity to be instrumental in developing and delivering GSK’s R&D aims. Strong experience of working in complex matrix-environment, with demonstrable clear problem-solving approach to your work is essential. Strong people skills and a proven ability to influence people to achieve and drive performance are also prerequisites for this role.
Basic Qualifications:
- Relevant degree-level education (e.g., life sciences or related discipline).
- Relevant clinical research/study management and operations experience in a pharmaceutical/scientific environment.
- 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.
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.
GSK is an Equal Opportunity Employer. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Global Study Manager in London employer: GlaxoSmithKline plc
GSK is an exceptional employer that fosters a culture of innovation and collaboration, making it an ideal place for professionals seeking to make a meaningful impact in the biopharma industry. With a commitment to employee growth through continuous learning opportunities and a flexible hybrid working model, GSK empowers its workforce to thrive while contributing to groundbreaking advancements in healthcare. Located in vibrant London, employees benefit from a dynamic work environment that prioritises ambition for patients and accountability for results.
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