Global Study Manager
AstraZeneca AB / Biomedicinjobb / Göteborg
2022-06-02
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➡️ Klicka här för den senare publicerade platsannonsen "Global Study Manager" (publicerad 2023-09-18) ⬅️
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hela Sverige Make a more meaningful impact to patients' lives around the globe
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.
If your passion is science and you want to be part of a team that makes a bigger impact on patients' lives, then there's no better place to be.
The Global Study Manager (GSM) reports to the Global Study Associate Director who is the overall accountable for the delivery of the study. The GSM supports delivery of early-phase global clinical studies within Biopharmaceuticals R&D from study set-up through maintenance, close-out and study archiving. The GSM works cross-functionally with partners to lead & deliver aspects of the clinical study in accordance with delegation, applicable clinical trial regulations (ex. ICH-GCP), AstraZeneca Standard Operating Procedures (SOPs), AZ policies & standard methodologies and AZ values & behaviours.
The exact accountabilities will differ depending on the nature of the clinical study so you'll need a high degree of flexibility. You may work across many different studies and delivery models concurrently.
Some of the GSM's accountabilities are as follows:
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Perform study management tasks as per agreed delegation by the Global study Associate Director
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In partnership with internal specialists and external service providers, provide oversight (as delegated) to ensure study delivery of both internally-run and outsourced studies.
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Lead/contribute to the preparation of study documents (e.g. Informed Consent Form, applicable study plans, etc.), and external service provider-related documents (e.g. specifications, study specific procedures, etc.)
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Maintain and facilitate interactions with functions to ensure efficient study delivery to time, costs and quality objectives.
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Lead the set-up and maintenance of third-party vendors.
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Proactively contribute to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
Essential requirements
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University degree (or equivalent educational/work experience), preferably in medical or biological sciences or subject area associated with clinical research
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Relevant pharmaceutical industry and/or clinical trial experience
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Deep understanding of ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development
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Validated organizational, time management & analytical skills; excellent attention to detail and ability to multi-task in a fast-paced and dynamic environment
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Proven ability to work well both on a cross-functional team and independently
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Strong collaborative communication skills (verbal & written) in English
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Ability to prioritise appropriately and to be adaptable
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Demonstrated leadership skills
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Computer proficiency in day-to-day tasks
Desirable requirements
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Experience in external service provider management
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Experience in all phases of a clinical study lifecycle
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Demonstrated project management skills
Be empowered to be innovative and creative where difference is valued
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.
Complete your application before the below closing date.
This role is open until June 16th, 2022.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2022-06-02ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2022-06-16
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-135202".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 6705628
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