Global Study Manager Oncology

hace 2 semanas

Barcelona, España AstraZeneca A tiempo completo

**Location: Barcelona - On-Site**

**Short role description**

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.

**Typical Accountabilities**
- In partnership with AZ enablement team, other AZ clinical experts and external serviceproviders, the GSM provides oversight to ensure study delivery.
- Leads/contributes to the preparation of delegated study documents (e.g. InformedConsent Form, master Clinical Study Agreement etc), and external service providerrelated documents (specifications, study specific procedures, descriptions,presentations etc.).
- Maintains and facilitates interactions with internal functions including but not limited toEnablement, Data Management, Procurement, Regulatory, Patient Safety and QualityAssurance, and external functions including the CROs and other external serviceproviders 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 SupplyChain or external service providers as appropriate.
- Proactively contributes to risk and issue identification, development of mitigation and/or actionplans for identified risks and issues.
- Ensures that all study documents in scope of GSM’s responsibilities are complete and verifiedfor quality in Trial Master File.
- Supports GSD/GSAD with budget management, such as external service provider invoicereconciliation.
- Adheres to global clinical processes, procedural documents, applicable Quality &Compliance manual documents and international guidelines such as ICH/GCP to ensurestudy 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 toensure study delivery according to agreed timelines, budget and quality standards, whileensuring 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.

**Education, Qualifications, Skills and Experience**

**Essential**:

- University degree (or equivalent),preferably in medical or biologicalsciences or discipline associatedwith clinical research.
- Relevant experience from withinthe pharmaceutical industry orsimilar organization or academicexperience, preferably of at least 3years.
- Knowledge of clinical development /drug development process invarious phases of development andtherapy areas
- Excellent knowledge ofinternational guidelines ICH/GCP
- Excellent communication andrelationship building skills, includingexternal service providermanagement skills
- Good project management skills
- Demonstrated ability to collaborateas well as work independently
- Demonstrated leadership skills
- Computer proficiency, advancedcomputer skills in day-to-day tasks
- Excellent verbal and writtencommunication in English

**Desirable**
- Advanced degree
- Experience in all phases of a clinical studylifecycle
- Basic knowledge of GXP outside ofGCP (i.e GMP/GLP)

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