Global Study Associate Manager
The GSAM is a member of extended global study team supporting delivery of clinical studies within Global Medicines Development (GMD) to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving.
The GSAM works cross-functionally with internal and external partners to deliver delegated aspects of the clinical study in accordance with Global Study Leader (GSL) in delegated aspects of clinical study execution in accordance with the Study Team Operating Model (STOM), AZ Project Management Framework, current clinical trial regulations (e.g. ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and best practices (e.g. AZ guidelines) and in line with AZ values and behaviours.
• In partnership with AZ enablement team, other AZ clinical experts and external service providers, the GSAM provides oversight to ensure study delivery.
• Leads/contributes to the preparation of delegated study documents (e.g. 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 internal functions including but not limited to Enablement, Data Management, Procurement, Regulatory, Patient Safety and 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 appropriate
• 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 Trial Master File
• Supports Global Study Leader (GSL) with budget management, such as external service provider invoice reconciliation
• Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP to ensure study is inspection ready at all times
• Supports Global Study Leaders (GSL) in project management as per agreed delegation
• For outsourced studies, supports Global Study Leader (GSL) in management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented 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
• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
• Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
• Knowledge of clinical development / drug development process in various phases of development and therapy areas
• Excellent knowledge of international guidelines ICH/GCP
• Excellent communication and relationship building skills, including external service provider management skills
• Good project management skills
• Demonstrated ability to collaborate as well as work independently
• Demonstrated leadership skills
• Computer proficiency, advanced computer skills in day-to-day tasks
• Excellent verbal and written communication in English
• Advanced degree
• Experience in all phases of a clinical study lifecycle
• Basic knowledge of GXP outside of GCP (i.e GMP/GLP
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
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 authorisation and employment eligibility verification requirements.