Global Study Manager
AstraZeneca AB / Biomedicinjobb / Göteborg
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hela Sverige Do you have experience in clinical study management and would like a role where your expertise, as well as your leadership skills, will be highly appreciated? Are you team oriented and do you, as we do, put patients first in your work to make a difference? Then AstraZeneca might be the right place for you to contribute and thrive.
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies.
Here you'll have the opportunity to make a meaningful difference to patients' lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines - for the world's most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.
With deep roots and a proud heritage, AstraZeneca is a well-known brand and respected company, with a strong reputation in both the scientific community and academia.
We are recruiting for a Global Study Manager who will join our Study Management Cardiovascular Renal Metabolic Diseases (CVRM) team - which forms part of BioPharmaceuticals Clinical Operations . The position will be based in one of our vibrant R&D sites, either in Gothenburg, Sweden or in Gaithersburg, US.
Study Management CVRM, are accountable for delivering high quality, cost efficient clinical studies (phase 1 to phase 3) that support drug development within Cardiovascular Renal Metabolism (CVRM).
We expect employees to be on-site for a minimum of three days per week and will therefore be unable to offer remote based working.
What you'll do:
As a Global Study Manager you will play a key role in the study team and work closely with the Global Study Leader to fulfil their accountabilities through coordinating activities that ensures quality, consistency and integration of study data. You will maintain and facilitate interactions with both internal & external functions to provide oversight and ensure efficient study delivery to time, costs and quality objectives, in both internally-run and outsourced studies. The exact accountabilities will differ depending on the exact nature of the clinical program so a high degree of flexibility is required.
The responsibilities will also include:
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To support the Study leader in project management as per agreed delegation.
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Lead the preparation of delegated study documents (e.g. Informed Consent Form, applicable study plans, etc.), and external service provider-related documents such as specifications, study specific procedures, contracts etc.
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Management of study vendors.
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To ensure adequate supply of study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
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Proactively contribute to risk and issue identification, identification of critical to quality factors, development of mitigation and/or action plans for identified risks and issues.
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Adhere to AZ SOPs, global process, applicable Quality & Compliance manual documents and international guidelines (e.g. ICH-GCP) to ensure study is inspection ready at all times.
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Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their line manager.
Essential Requirements:
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Experience working within a global clinical study team and managing third party vendors.
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Experience working with country/regional study teams.
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University degree (or equivalent educational/work experience), preferably in medical or biological sciences or discipline associated with clinical research.
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Experience from pharmaceutical industry and clinical trial experience.
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Good understanding of the drug development process, study management, drug handling and data management as well as deep understanding of ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development.
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Proven organizational, time management and analytical skills; demonstrate very high quality in English, both in written & verbal communication.
To succeed in the role, we also believe that you are team oriented and have ability to prioritize appropriately and manage multiple deliverables. We would like you to have demonstrated leadership skills and hope that you enjoy managing change and actively seek and champion more efficient and effective processes. You work independently and have good communication, collaboration and interpersonal skills.
Desirable Requirements:
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Knowledge about our therapeutic areas (CVRM )
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Experience from independently leading workstreams within clinical studies
Why AstraZeneca?
At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
So, what's next?
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. We welcome your application, no later than October 2nd.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2023-10-02
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-180174".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Kontakt AstraZeneca
birgitta.nystrom@astrazeneca.com Jobbnummer 8120461
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