Planning and leading the delivery of assigned studies to timelines, quality, budget, company standards and scientific requirements; from concept to a handover point applicable to the study type, which may be up to final study report and archiving.
Supporting the coordination and delivery of a fully feasible Study Protocol and any other relevant study documentation.
Supporting the Scientific Lead in the assessment and selection of appropriate vendors and leads on the engagement and management of selected vendors.
Working with matrix partners, manager and / or NIS P&D TA Study Delivery Head to develop and manage study level budget within project budget allocation.
Ensuring prompt escalation of study and project level issues and risks to manager or NIS P&D TA Study Delivery Head, as appropriate.
Working effectively in partnership with the Scientific Lead (and extended team, if required) to deliver assigned studies. Interacts 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 for their designated studies.
May lead or contribute to initiatives to improve processes and / or ways of working.
Delivery Lead • Bengaluru, Karnataka, India