Global Study Manager

The Global Study Manager (GSM) is a vital member of the extended global study team, ensuring the delivery of clinical studies within BioPharmaceuticals Clinical Operations. From the development of the Clinical Study Protocol (CSP) through study set-up, maintenance, close-out, and the creation of the Clinical Study Report (CSR) to study archiving, the GSM plays a crucial role. Collaborating cross-functionally with internal and external partners, the GSM supports the Global Study Director (GSD) or Global Study Associate Director (GSAD) in executing clinical studies according to the Delivery Model, AZ Project Management Framework, current clinical trial regulations (e.g., ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), policies, best practices, and values.

Accountabilities

- In partnership with AZ 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 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 and/or 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 GSD and/or GSAD with overall project management as per agreed delegation.
- For outsourced studies, supports GSD and/or 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 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.

Essential Skills/Experience

- 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

Desirable Skills/Experience

- Advanced degree
- Experience in all phases of a clinical study lifecycle
- Basic knowledge of GXP outside of GCP (i.e GMP/GLP)
- Having experience in cell therapy will be valued.

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.

Thrive in a place where the brightest and most curious minds seamlessly come together in our inclusive environment. Here all doors are open, and every voice is heard. From working side-by-side with academia to innovating with biotech, we are forever expanding our horizons. By sharing and increasing our knowledge we are empowered to be the best we can be and accelerate progress.

Ready to make a difference? Apply now!

Location: Barcelona. Please apply with an english resume

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.