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Arbetsbeskrivning
We are now recruiting a DCT Logistic Project Manager to Digital Health R&D
Digital Health R&D's ambition is to transform healthcare, powered by digital, science and partnerships, to deliver the healthcare outcomes and experience that patients care about the most. Now we are further accelerating our transformation efforts to ensure we demonstrate the best in new technology and leading-edge capabilities to keep us at the forefront of future drug development.
Digital Health R&D is reimagining how we work to position AstraZeneca as an industry leader, making the development & delivery of new medicines easier. We're doing this by harnessing the latest innovations enabled by digital, data & analytics and working with our people to design and build the technology and working practices.
AstraZeneca's Digital Health R&D Patient Health & Innovation organisation develops digital solutions to support our development and commercial drug portfolios. These digital solutions (e.g. Unify) encompass connected monitoring devices and sensors coupled with medical device software to:
* Improve clinical development, through optimising data collection and improving communications between AZ, HCP and patients
* Provide enriched data sets to support regulatory submissions, and differentiated labelling
* Optimise real world medication use by patients and deliver digital interventions to improve clinical outcomes
As part of the Digital Health R&D the team will develop and execute AZ's R&D Digital strategy. The program has already delivered the first versions of bespoke digital solutions for clinical trials globally, built on a standardized set of modules to enable identification and recruitment of patients, ongoing engagement and retention, support to sites and collection of data directly from patients.
What you'll do
One of the main challenges in a Decentralized Clinical Trial is to provide required material to the patients in the right time and place. The DCT Logistic Project Manager will lead the development and implementation of suitable supply chain(s) to manage all relevant aspects of a DCT trial with the exemption of IMP or other pharma products. This includes handheld devices (mobile phone/tablet), medical devices, auxiliaries and any other material required in the participation of the clinical trial.
In this role you will collaborate with a range of cross-functional specialist to define and deliver a state of the art experience for the patient as they receive or return any material required for the trial. This include working with Service Design specialists, Clinical trial experts, logistic experts and quality assurance organisations to make sure this is done in compliance with regulations, efficiently and with an excellent user experience.
You will define and deliver suitable strategies for each area involved from sourcing to shipment and to re-use or sustainable decommissioning of the material. This likely include working with internal and external organizations to define an end-to-end process for material.
* Lead the development and implementation of suitable supply chain(s) to manage all relevant aspects of a DCT trial with the exemption of IMP or other pharma products.
* Lead a cross functional team to define an end-to-end process to enable delivery and return of hardware and other material to patients in a clinical trial.
* Collaborate with SMEs across Supply Chain, Procurement, Quality Assurance, Sustainability and Clinical Development.
* Define and implement processes for re-use, re-qualification and storing of key components to minimize carbon footprint and a sustainable process.
* Work closely with the Implementation Director/Leads within DPS & Unify as well as other products in Digital Health.
* You will need a deep understanding of business needs and users' needs to craft the processes, solution and prioritise improvement needs.
* Understand the external landscape of related services
* Help build a learning organisation: ensure that any learning associated with the programs is shared within the Digital Organisation
Essential Requirements
* Life Sciences or Logistic degree or equivalent experience
* Knowledge about Clinical trial delivery
* Excellent Project Management skills with a focus on process driven areas
* Knowledge of GCP, 21 CFR part 11, relevant guidelines ISPOR, ISOQOL, FDA, EMA
* Ability to work collaboratively in a cross functional setting with internal as well as external partners
* Ability to challenge the status quo, take ownership and holds self and others accountable
* Senior Stakeholder management skill with together with proven negotiation, influencing, collaboration and interpersonal leadership skills
* Effective problem and conflict solving skills
* Excellent written and verbal communication skills, with the ability to deal with ambiguity and create clarity
* Passion for Customers, representing the needs of multiple customers in decision making.
Desirable
* Understanding or experience of Service Design
* Thrives in a fast-paced work environment, comfortable with complexity and uncertainty at times, lots of humour, dedication to deliver outcomes and motivated by the opportunity to rethink our approach to healthcare.
* Comfort and skills operating in a heavily matrixed organizations with excellent skills and intuition to manage the needs of various partners.
* Ability to rapidly grasp concepts and excellent ability to handle complexity by simplifying it and providing clear directions to the team
* Ability to manage and influence strategically and persuade tactfully, to acquire desired outcomes while maintaining effective, positive, organizational relationships
* Comprehensive understanding of dynamics affecting the pharmaceutical industry and needs for transformation
* Ability to work globally including international travel
So, what's next?
Are you already imagining yourself in this position? Good, because we can't wait to hear from you! Welcome with your application
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