- Provide oversight to a study delivery area delegated by the Global Study Leader (GSL) in partnership with AZ Process and Enabling Solutions team, other AZ clinical experts and external service providers
- Leads/contributes to the preparation of delegated study documents (e.g. master Informed Consent Form, master Clinical Study Agreement etc), and external service provider related documents (specifications, study specific procedures, descriptions, presentations etc.)
- Maintains and facilitates interactions with delegated internal functions such as Process and Enabling Solutions, Data Management, Procurement, Regulatory, Patient Safety and R&D Quality Assurance, and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives
- Contributes to the planning and conduct of internal and external meetings (e.g. Investigators’/Monitors’ meeting)
- Ensures the supply of investigational product and study materials by liaising with Clinical Supply Chain or external service providers as delegated
- Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues
- Ensures that all study documents in scope of GSAM’s responsibilities are complete and verified for quality in the Trial Master File
- Supports the GSL with budget management, such as external service provider invoice reconciliation
- Adheres to global clinical processes, procedural documents, applicable quality and compliance manual documents and international guidelines such as ICH GCP to ensure study is always inspection ready
- Supports the GSL in project management as per agreed delegation
- For outsourced studies, supports the GSL in the management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards, while ensuring appropriate level of CRO oversight throughout the lifecycle of the study, in accordance with relevant AZ SOPs and guidelines (e.g. description of services and transfer of obligations)
- Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager

Date Posted

Closing Date

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.