As R&D efforts follow science without constraint, we need to take full advantage of our internal data and expertise, as well as leverage solutions and technology, to inform, optimize and validate our clinical trial protocols and study delivery plans.
The Feasibility Analytics Lead will support study teams in creating data driven, high quality insights and modelling to support clinical operations project and study team members. Data mining and analyses of internal and external clinical trial, epidemiology, real-world, diversity & inclusivity, pricing & reimbursement and publicly available data sources to generate actionable intelligence to drive global, regional and site level clinical trial strategies to optimize and operationalize clinical trials. This role will directly support clinical operations planning & feasibility activities.
Key Responsibilities:
Partner alongside the Study Strategic Planning Lead (SSPL) with the study teams (Clinical Scientist, Central Monitoring Lead, Clinical Operations Asset Lead, Study Delivery Lead, Global Regulatory, Global Medical, Epidemiology, Global Marketing/Commercial and Local Delivery Lead) within the existing Clinical Delivery Plan (CDP) processes, to provide data informed clinical trial intelligence and insights for the clinical operational plan
Generate and communicate the actionable intelligence generated from current and emerging data sources on clinical trials at a global, country and a site level, relating to study budget and moderator for the clinical trial operational viability meeting
Understand the value of clinical trial solutions (digital [eCOA, ePRO, mobile nursing, DTP, Telemedicine, etc.] and Patient Engagement/Recruitment solutions) to de-risk, optimize and enhance investigator and patient experience within clinical trials and relate ROI to study budget
Working in close partnership with the network of local offices (GMASE and Clinical monitoring), integrating feedback into current processes to impact site selection and clinical trial operational outcomes
Provide timely, high-quality deliverables (e.g. recruitment modelling plans, feasibility report) to SSPL and clinical trial teams to support the clinical trial planning
Coordinating development of feasibility documentation to support the study including Country Pre-Selection Proposals, Feasibility KOM slides, and Feasibility Questionnaires
Identify and share trial informatics best practice and exemplars within Clinical Operations.
Demonstrate ownership and accountability through effective problem solving throughout the feasibility process
Supports the Subject Matter Expert or System Business Owner for tools and systems
Supports the assessment, piloting and embedding of new data analytics and data sources to ensure GSK continues to access best in class solutions
Provide mentoring and coaching to junior members of staff
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree in STEM
9+ years of relevant industry experience
Previous experience in a clinical development operations or study feasibility role at a CRO, pharmaceutical company or other relevant environment
Track record in problem solving.
Results orientated with a drive to set and reach challenging goals with high standards for performance
Excellent written and verbal communication skills
Ability to work in a matrix environment
Understanding of the drug development process
Understanding of all relevant industry guidelines (ie; FDA, GCP and ICH guidelines)
Preferred skills:
Experience utilizing clinical trial recruitment modelling tools
Experience utilizing industry clinical trial related data sources (i.e., CiteLine, DQS, TriNetX, etc.)
Experience across therapeutic areas would be advantageous
Experience with data manipulation, visualization, or advanced analytics
High level of proficiency with Microsoft Office
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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