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Global Study Manager
3 weeks ago
The GSM is a member of extended global study team supporting delivery of clinical studies within Late
Development Oncology (LDO) 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 GSM works cross-functionally with internal and external partners to deliver delegated aspects of the clinical study in accordance with the Global Study Director (GSD) / Global Study Associate Director (GSAD) 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.
Accountabilities
- In partnership with AZ enablement 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 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 GSM’s responsibilities are complete and verified for quality in Trial Master File.
- Supports GSD/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 GSADs in project management as per agreed delegation.
- For outsourced studies, supports GSD/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
**Qualifications**:
- 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
