Project Manager

2 weeks ago


Mumbai Maharashtra, India AstraZeneca Full time

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 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 Why AstraZeneca At AstraZeneca we re dedicated to being a Great Place to Work Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit There s no better place to make a difference to medicine patients and society An inclusive culture that champions diversity and collaboration and always committed to lifelong learning growth and development We re on an exciting journey to pioneer the future of healthcare Date Posted 11-Jun-2025 Closing Date 30-Jul-2025 AstraZeneca embraces diversity and equality of opportunity We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills We believe that the more inclusive we are the better our work will be We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics We comply with all applicable laws and regulations on non-discrimination in employment and recruitment as well as work authorization and employment eligibility verification requirements


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