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|Job Category :
||Associate Director Study Data Manager
||Gaithersburg, MD 20878
|Job Description :
||Do you have significant Lead Clinical Data Management experience? Can you envision using your expertise to make a positive impact on changing patients’ lives? If so, then this role might be the one for you!
AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease.
Development Operations is here to deliver science through a wide range of specialist expertise, operational excellence and data driven innovation. These enable us to drive extensive clinical trial programs from design to regulatory submission and approval. Providing the key connection between science and commercialisation, we deliver trials and submissions to the highest standards of quality, efficiency and ethics to thousands of patients globally.
Data Management (DM), part of Clinical Data and Insights (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 Associate Director Study Data Manager, you’ll provide leadership and operational knowledge in the planning and delivery of Clinical Data Management (CDM) work at a study level. You will coordinate CDM tasks on clinical studies assigned to you, where you are the main point of contact for DM (for vendors and in-house). Furthermore you are expected to communicate with and provide guidance and supervision tointernal and external partners .
This role will be responsible for:
Providing oversight of the day to day operational aspects of CDM for assigned studies; Responsible to identify risks and collaborate with the DM Vendor to mitigate the same.
Drive alignment to AZ CDM standards and processes for data quality and consistency of data collecting for assigned studies. Understanding therapeutic area, indication or program specific data capture standards.
Provide input into CDM related activities associated with regulatory inspections/audits for assigned studies.
Responsible for compliance to Trial Master File requirements.
Review, assess and lead DM Vendor delivery against critical metrics, timelines, budget and overall performance.
Maintain an awareness of the external and internal models in order to participate in change initiatives and continuous improvement activities related to CDM operating models.
Demonstrates willingness to tackle ad hoc activities consistent with current or experience in support of CDM.
You can be based in either of the following offices in Gothenburg – Sweden, Cambridge – UK, Warsaw – Poland, Bangalore – India or Gaithersburg – US
Essential for the role
You hold a university degree in life sciences or related field, which is complemented by significant Clinical Data Management experience from Pharma or CRO. Your communications and collaboration skills are excellent, showcasing the ability to operate tactfully in a global setting across several cultures.
Collaboration is key in this role, and we expect you to nurture a well-functioning partnership with external as well as internal collaborators. You are not afraid of holding others accountable for their responsibilities, and you communicate in a clear and respectful way.
You also possess:
Proven current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements
Demonstrate understanding and experience in query management process and reconciliation activities
Ability to work independently without close supervision
Ability to work in a distributed team environment
Excellent organizational and analytical skills and high attention to detail
Desirable for the role
Knowledge of clinical and pharmaceutical drug development process
State of the art understanding of database structures, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting
Understanding of clinical data system design, development, validation and system interoperability
Experience as a lead of early phase trials
Specific knowledge in the TA area of Respiratory & Immunology
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 March 2nd, 2022 and welcome your application no later than March 16th, 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
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