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Global Study Manager
2 weeks ago
At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
**Introduction to role**:
The Global Study Manager (GSM) plays a crucial role in the extended global study team, ensuring the successful delivery of clinical studies within BioPharmaceuticals Clinical Operations. From the development of the Clinical Study Protocol (CSP) through to study archiving, the GSM supports the entire lifecycle of clinical studies, focusing on time, cost, and quality. Collaborating with internal and external partners, the GSM ensures that all aspects of clinical study execution align with AstraZeneca's standards, regulations, and values.
**Accountabilities**:
In partnership with the AZ team, other AZ clinical experts, and external service providers, the GSM 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 and external functions including CROs and other external service providers to ensure 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 collaborating closely 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 GSM’s responsibilities are complete and verified for quality in Trial Master File.
- Supports GSD and/or GSAD 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 GSD and/or GSAD with overall project management as per agreed delegation.
- For outsourced studies, supports GSD and/or GSAD 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.
**Essential Skills/Experience**:
- University degree (or equivalent experience), preferably in a field related to medical or biological sciences or clinical research.
- Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
- Relevant experience in cell therapy area.
- 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.
**Desirable Skills/Experience**:
- Experience in all phases of a clinical study lifecycle.
- Basic knowledge of GXP outside of GCP (i.e., GMP/GLP).
LI-Hybrid
