Study Delivery Lead - Non-Interventional Study

Job Purpose

We are looking for a Study Delivery Lead to join our team on a permanent basis.

This exciting role will allow you to lead the design, execution, and reporting of studies within the Non-Interventional Study (NIS) portfolio, including primary data collection studies and site-based studies delivered via Third Party suppliers. The NIS P&D SDL is accountable for the assessment, selection, engagement, and management of appropriate vendors and acts as the primary contact for vendor at study level.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK.

• Planning and leading the delivery of assigned studies to timelines, quality, budget, company standards and scientific requirements; from concept to final study report and archiving.
• Accountable for a study delivery strategy (e.g. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms/tools etc) which ensures consistency with asset plans.
• Accountable for the coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents and Clinical Study Reports.
• Taking ownership of operational problem-solving and decision-making. Making informed decisions that weigh risk verse benefit, with a clear understanding of the impact on the study and project. Proactively addresses risks and escalates issues to the NIS P&D TA Study Delivery Head when necessary.
• Building productive partnerships to support your studies and collaborating with therapy aligned staff in other functions. Interacting effectively across boundaries with other global functions using influencing and relationship-building skills.
• Ensuring compliance with ICH/GCP & ENCePP guidelines and/or applicable guidelines for NIS such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations, and GSK SOPs, for all products and services delivered on your designated studies.

• Bachelor’s degree (or equivalent) in life sciences or related discipline +
• Proven experience in clinical operations or related research, specifically in study management.
• Knowledge and experience of Non-Interventional Studies (NIS), Registry studies, Phase IV clinical trials or PASS/PAES.
• Ability to work independently and proactively and to take on leadership roles in cross-functional teams.
• Demonstrated experience leading in a matrix environment to deliver studies, develop clinical plans, and manage change.
• Ability to establish and build internal and external relationships (e.g. Third Party suppliers) at all levels in a highly dynamic and matrixed environment.

• Advanced degree (e.g. MS, PhD, Pharm
  
  D) or equivalent experience.
• Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
• Proven experience in managing relationships with vendors to ensure successful delivery of studies.
• Demonstrated in-depth knowledge of study management, essential regulatory guidelines worldwide, and the clinical development process.
• Experience with budgeting and forecasting, commercial and financial acumen.

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in…