Global Study Manager

As a Global Study Manager (GSM), you will be an integral part of the extended global study team, supporting the delivery of clinical studies in Haematology Clinical Operations. From the development of the Clinical Study Protocol (CSP) through to study set-up, maintenance, close-out, and the creation of the Clinical Study Report (CSR), you will ensure that studies are conducted to time, cost, and quality standards. You will provide country and vendor oversight, working cross-functionally with internal and external partners to deliver delegated aspects of the clinical study in accordance with the Global Study Director (GSD) or Global Study Associate Director (GSAD). Your role will adhere to the Study team Operating Model for Internal Delivery (SOLID) or SOLIS, AZ Project Management Framework, current clinical trial regulations (e.g., ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies, and best practices.

Accountabilities

- Contribute to the development and updates of study documents, ensuring template and version compliance.
- Lead or contribute to the preparation of delegated study documents and external service provider-related documents.
- Manage the set-up of third-party vendors, including initial statement of work, budget assessment, and change order processes.
- Provide oversight to ensure study delivery in partnership with AZ enablement team, other AZ clinical experts, and external service providers.
- Maintain interactions with internal functions such as Enablement, Data Management, Procurement, Regulatory, Patient Safety, and Quality Assurance, as well as external functions including CROs and other service providers.
- Contribute to the planning and conduct of internal and external meetings.
- Ensure the supply of Investigational product and study materials by liaising with Global Clinical Supply or external service providers.
- Support risk management and quality efforts to ensure study compliance.
- Ensure that all study documents within GSM’s responsibilities are complete and verified for quality in the Trial Master File.
- Support GSD/GSAD with budget management, including external service provider invoice reconciliation.
- Adhere 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.
- Support GSADs in project management as per agreed delegation.
- For outsourced studies, support GSD/GSAD in managing the CRO Project Manager to ensure study delivery according to agreed timelines, budget, and quality standards.
- Support the study team in implementing audits and regulatory inspections.
- Contribute to reviewing new/amended/unique SOPs and guidance documents throughout the lifecycle of the study.
- Take on assignments in process improvements or leading improvement projects as discussed and agreed upon with their manager.

Essential 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 proven experience in driving operational delivery to timelines, costs, and quality.
- Proven experience leading delivery through internal and external organizations.
- Strong, demonstrated abilities/skills in matrix team leadership.
- Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills.
- 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 manage competing priorities.

Desirable Skills/Experience

- Higher university degree e.g., PhD, MSc.
- 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.).

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are dedicated to pioneering new science and breaking boundaries with our ambitious and innovative pipeline. Our focus on evaluating novelty and clinical development movement has led us to achieve top rankings on the invention scale by IDEA Pharma in 2019 and 2020. With an ambitious goal to deliver 6 new molecular entities by 2025, we continue to push forward with bold innovations and integrated healthcare systems. Our collaborative research environment unites academia and industry to expedite research in some of the hardest-to-treat cancers. Join us to build a rewarding career while improving the lives of millions with cancer.

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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.