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
Lead Manager • Bengaluru, Karnataka, India