Global Study Manager Haematology
hace 6 meses
**Location: Barcelona (On-site)**
**Why AstraZeneca?**
At AstraZeneca, we are united in our vision to eliminate cancer as a cause of death. We are a science-based, leading and crucial Oncology enterprise, constantly pushing the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. With one of the broadest and deepest Oncology pipelines in the industry, we offer many opportunities to work with new and novel drugs and help discover what's next.
We are diligent and committed to our science-driven approach, with a sharp focus on outcomes. To stay at the forefront we remain fearless and agile for our rapidly changing markets. We transform the way cancer is treated to make an important difference to people and patients.
Our commitment to patients and pioneering spirit are truly embedded and it's what makes our pipeline unique. We dig deeper into the data, using different methodologies and complex models to have a greater impact and challenge ourselves along the way. We champion a mindset of courage, where everyone is empowered to step up, innovate and work at pace.
**Accountabilities**:
As a GSM, you will contribute to the development of study documents, manage the set-up of third-party vendors, provide oversight to ensure study delivery, maintain interactions with internal and external functions, ensure the supply of Investigational product and study materials, support risk management and quality efforts, support budget management, adhere to global clinical processes, support the study team in the implementation of audits and regulatory inspections, and take on assignments on non-drug project work in process improvements.
**Crucial Skills/Experience**:
- University level bachelor’s degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
- Minimum of 5 years progressive experience in clinical research, with at least 3 years of clinical development project management experience, or equivalent.
- Extensive knowledge of clinical research regulatory requirements (incl ICH-GCP) and demonstrated abilities in clinical study management processes and clinical/drug development.
- Extensive and validated experience in driving operational delivery to timelines, costs, and quality.
- Shown experience leading delivery through internal and external organizations.
- Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and partners.
- Experience in providing clear requirements and selection of external contracts.
- Excellent communication and interpersonal skills.
- Strong strategic and critical thinking abilities.
- Strong organizational and problem-solving skills.
- Ability to lead challenging priorities.
**Desirable Skills/Experience**:
- Higher university degree e.g., PhD, MSc or equivalent experience.
- Experience in all phases of a clinical study lifecycle.
- Basic knowledge of GXP outside of GCP (i.e., GMP/GLP).
- Experience in haematology therapeutic area.
- Vendor management experience (e.g., IRT, labs etc.).
At AstraZeneca, we are committed to pushing the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what's next. We foster an attitude of courage, where everyone is empowered to step up, innovate and work at pace.
Our pipeline is a testament to our growth, both now and in the future. Our values are evidence of our dedication to Oncology and our people. By working with diverse functions, we get exposure to multidisciplinary learning and different perspectives.
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