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Arbetsbeskrivning
Are you a passionate Project Coordinator with knowledge of Clinical Trials? If you can you envision using your expertise to impact patients' lives, then AstraZeneca might be the one for you!
At AstraZeneca, we are building a Data Management function equipped to manage all aspects of data management for clinical trials. With this approach, we will use internal systems, standards and processes and align the right resources to deliver efficient and high-quality services by applying an innovative approach.
Data Management (DM), part of CDI, includes activities and tasks performed on clinical study data, including planning, data capture in CRF/eCRF and quality assurance up to Clean File/Database lock. Join us and be part of a phenomenal place to work and an environment that energizes and empowers each of us to contribute to achieving our goal to develop and deliver life-changing medicines.
What you'll do
As Implementation Leader, you will get the opportunity to secure the success of this important project by being responsible for coordinating dependencies, manage timelines and perform partner management. Additionally, you will build a robust governance organisation and ensure tracking of risks and mitigations.
You are expected to lead the strategical approach of the planning and delivery of the Data Management implementation and build a strong network of local study contacts to support implementation and troubleshooting.
Your overarching project responsibility is combined with detailed systems- and technical knowledge. We will also rely on you to possess a detailed understanding of health authority requirements, in order to collaborate closely with Clinical Quality Assurance to provide input into Clinical Data Management related activities associated with regulatory inspections and audits.
You will be responsible for:
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Ensures that all aspects of internalization have been accurately budgeted and funding is secured
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Collaboration with key partners and sponsors to ensure that systems are in place with relevant support mechanisms to allow for ease of working in a BAU environment
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Taking an infrastructure expert role, providing DM input and project manage system changes
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Set up and ensure timelines in a project plan to allow transition of vendors into AstraZeneca ways of working
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Representing Clinical Data Management at multi-functional forums, meetings and providing feedback to partners
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Support the build of a learning organization by ensuring that any learning associated with the programs is shared with relevant organizations and partners
This is an 18 months temporary role and you can be based in Gothenburg - Sweden, Cambridge - UK, Warsaw - Poland or Bangalore - India.
Essential for the role
You hold a degree in life sciences or related field with experience of excellent management of several parallel projects in a matrix environment. Additionally, you have a solid understanding of clinical trials' methodology, GCP, GDMP and medical terminology, as well as extensive experience of managing vendors, budgets, timelines and risks.
Furthermore, you are known for your good interpersonal, negotiating and communication skills and you pay high attention to cultural awareness.
You also possess:
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Great understanding of IT systems
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High attention to detail and a strong analytical mind-set
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Demonstrable ability to operate effectively in a global environment
Desirable for the role
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Thrives in a fast-paced work environment, comfortable with complexity and uncertainty at times, dedication to deliver outcomes and motivated by the opportunity to rethink our approach to healthcare
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Significant Clinical Data Management experience, preferable both from CRO and Pharma industry in more than one therapeutic area
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PMP certification
Why we love it
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. Here, we truly understand science and apply it every day to strengthen and grow our pipeline.
So, what's next?
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
We open this role from June 1st, 2022 and welcome your application no later than June 15th, 2022
Where can I find out more
Our R&D Story: https://www.youtube.com/watch?v=pmFx_jr2eFo
Sustainability at AstraZeneca: https://www.astrazeneca.com/sustainability.html
Inclusion & Diversity at AstraZeneca: https://careers.astrazeneca.com/inclusion-diversity
Kontaktpersoner på detta företaget
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