Global Study Director

hace 3 semanas

Barcelona, España AstraZeneca A tiempo completo

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 dedication to sustainability is also central fit 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.

**What you’ll do**:
The **Global Study Director** is a business-critical role within Study Management Late, Haematology whose main accountability is the operational design, planning and delivery of high priority and complex clinical studies within a program, or across multiple studies in a program and/or therapy area that are deemed most critical to the business.

As a Global Study Director, you are responsible for leading a cross-functional study team (core and extended) and for providing the team with direction and guidance to enable successful study delivery. In addition, when working across a program/therapy area, the Global Study Director will provide guidance and support synergistic ways of working across all studies within the program.

You may provide input to early study planning activities based on operational expertise and are accountable for the delivery of studies by ensuring an effective partnership and teamwork within the study team.

**Responsibilities**:

- Lead and coordinate a team of experts in accordance with the study team operating model and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of timelines, budget and quality standards
- Contribute to vendor/external service provider selection activities at the study level, including bid defense, and lead operational oversight
- Assist the Senior Global Clinical Operations Director/Director Study Management with planning for upcoming clinical studies
- Collaborate with other functions to establish strategies and identify common practices aimed at increasing efficiency of global study teams
- Lead and facilitate communication across functions and provide guidance to study team members as needed
- For outsourced studies, be the primary AZ point of contact for the CRO Study Manager to ensure study delivery, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, following relevant AZ SOPs and guidelines (e.g. description of services and transfer of obligations)
- Provide operational expertise into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)
- Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities
- Develop and maintain relevant study plans including required input into study level quality and risk management planning with risk response strategies and clear issue resolution pathways
- Oversee study level performance against agreed upon plans, timelines and key performance indicators (quality and operational) by using company tracking systems and project timelines, while communicating any risks to timelines and/or quality, along with proposed mitigations
- Identify and report quality issues that have occurred and collaborate with all functions as necessary to overcome barriers and achieve desired outcomes
- Oversee Trial Master File (TMF) completion including ensuring the TMF plan and Expected Document List are in place and that QC activities are performed on an ongoing basis
- Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, budget attestations, Clinical Trial Transparency)
- Responsible for study budget re-forecasting following initial budget estimate provided by the Clinical Program Team and accountable for budget management through the study lifecycle
- Ensure studies are inspection-ready at all times, according to ICH-GCP and AZ SOP and relevant policies/guidelines
- Support professional development of team by providing regular feedback on individual performance
- Provide guidance, training, expertise, mentoring and support to less experienced study management colleagues
- Leads non-drug project work such as SMO representative in process improvements and/or leading imp

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