Global Study Leader
- Experience Level
Locations: Cambridge, UK Gaithersburg, US or Gothenburg, SE
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.
We're investing to enhance our understanding of disease as we work towards creating the next generation of therapeutics and pioneering new approaches to better predict clinical success.
As a GSL you're responsible for delivery of all aspects of global clinical studies. You will lead and maintain oversight for cross-functional teams comprised of internal and external partners. Ensuing delivery of clinical studies are done effectively and in accordance with clinical trial regulations (ex. ICH-GCP), AstraZeneca (AZ) Standard Operating Procedures (SOPs), AZ policies & standard methodologies and AZ values & behaviours.
You will lead, provide guidance and delegate appropriately to a cross-functional study team or lead all aspects of outsourced delivery activities. You will ensure studies are progressed as planned, driving achievement of milestones according to timelines, budget and quality standards. You may work on several studies at any one time. To do this successfully you will be able to lead and facilitate communication across multiple functions, work with multiple external service providers, ensuring delivery and performance to contracted goals and timelines/budget.
You will be accountable for leading the identification of overall study-level risk management activities and ensure mitigation strategies are implemented effectively. You'll be accountable for study budget management (and re-forecasting where required) through the study lifecycle and be able to drive and contribute to all aspects of study operations, including protocol writing, feasibility, vendor selection/start-up, site communication, database locks etc. You'll also work on non-drug project work such as process improvements as discussed and agreed upon with their line manager. May act as subject matter expert for a particular process or system within Early Study Management.
- You will be experienced in global clinical project management, comfortable with leading and running cross-functional study teams and leading external providers.
- University degree (or equivalent educational/work experience), preferably in medical or biological sciences or field associated with clinical research
- Extensive knowledge of clinical study management, ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development
- Extensive and proven experience in driving operational delivery to timelines, cost and quality and leading cross-functional study teams
- Strong strategic and critical thinking abilities and ability to manage complex situations
- Proven experience leading delivery through internal and external organisations
- Advanced degree, Masters level education (or higher)
- Project management certification
- Proven project management experience on a global level
- Experience in all phases of a clinical study lifecycle.
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.
Where can I find out more?
Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
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Opening date: 28th April 2021.
Closing date: 26th May 2021.