Project Manager
Project Manager
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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 worlds most serious diseases. But were more than one of the worlds 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 SOPs & 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 were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres 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. Were on an exciting journey to pioneer the future of healthcare.
Date Posted
11-Jun-2025Closing Date
30-Jul-2025AstraZeneca 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.
Required Experience:
IC
Employment Type
Full-Time
