Job
Description
About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world s most serious diseases. But we re more than one of the world s leading pharmaceutical companies. Job Description / Capsule Detailed Roles & Responsibilities: Works in close collaboration with the external service provider (CRO) and Investigators to ensure quality and quantity commitments are achieved in a timely and efficient manner. Responsible for ensuring that the study is conducted in accordance with AZ Procedures/ Applicable SOP s & Guidelines, such as ICH and GCP as well as relevant local regulations. Ensure delivery of the projects according to the commitment & set timelines. Initiate, conduct and deliver non interventional studies (local, regional and global) across TAs, External Service Provider Identification, Selection, and Work in close collaboration Initiate ESP contact (CRO, DM and Laboratory), exchange contracts and negotiate costs along with purchase team for DM, monitoring, central lab, translation, printing service, as applicable. Prepare clinical trial budget and get management approval after discussion. Assist in designing of study Protocol, CRF, ICF and other study related documents. Prepare Monitoring Plan, SDV and QC plan for the study. QC review of study documents, CRO and ASV along with CRO person to check QC Budget Preparation & approval. Work with medical colleagues on study protocol and related documents. Ensure quality conduct of the trial/study. Oversee site/Investigator identification and selection and SDV. Ensure Timely delivery of project from study start-up to DBL & CSR. Ensuring compliance with the Protocol, SOPs, ICH-GCP and other applicable regulatory requirements. Regular coordination with CROs to track progress of trial with target and actual milestones. During the trial, to take CAPA to ensure GCP compliance and reliability of data. Publication Management , Adherence to Publication Policy Essential Degree or equivalent professional qualification in related field Pharm D Experience in handling Clinical trials, observational studies, Publication and ESR Desirable Post-graduate qualification
