Senior Clinical Data Science Lead

As a Senior Clinical Data Science Lead you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Immediate Joiner Required Office-based - Bangalore/Chennai/Trivandrum • Works collaboratively with CROs and third-party vendors to design database, define quality specs, and resolve data management-related issues. • Assists in developing and maintaining DM standards and processes for both in-house and CRO studies in accordance with applicable SOPs and good clinical practices (GCP). • Provides consultation, leadership, and expertise to CRO DM and project teams on data management functions. • Acts as the data management lead for all assigned protocols, including contributing to the development and implementation of project plan. • Ensure standard processes are followed by all CROs for data management activities. Train CRO personnel on current processes. • Uses software applications to monitor and evaluate CRO performance (eg query status, data trends, detecting outliers and study progress). • Acts as a resource to the contract staff to identify problems and propose solutions to maintain projects within designated timelines. • Proactively identifies and implements opportunities for process improvements. • Provides expert review and help in the development of CRF/eCRF/eSource design specifications, validation specifications and report design, etc. Works with external service providers to help troubleshoot and resolve problems. • Ensures the consistency of CRF design and coding across studies and programs. • Contributes to protocols, clinical study reports, Investigator Brochures, Statistical Analysis Plans, INDs and other regulatory documents. • Prepares submission ready Electronic Case Report Forms (eCRFs) to support electronic submissions. Reviews SOW, provides input and ensures consistency across programs for data management activities to be outsourced to CROs. • Manages third-party vendors' (eg, CROs, EDC/eSource, and ancillary) processes, and local/central laboratories on defined data standards, content specifications, and timelines for deliverables. • Communicates and interacts with CRO vendors to ensure that project timelines are met with quality. • Provides status reports on the progress of projects/programs to internal team. • Ensures data management-related presentations for Investigator's meetings adhere to client's requirements. • Provides input in the development of departmental and global SOPs. • Serves as project team member and works closely with biostatistician and programmer to provide quality deliverables. • Other tasks assigned by Associate Director, Director or Sr. Director of Data Management

ICON is the world's largest and most comprehensive contract research organization (CRO). We are a global provider of outsourced drug and device development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We have offices in 53 countries and more than 16,000 employees worldwide.