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Product Director, Clinical Data Delivery

4 months ago

Gaithersburg, United States AstraZeneca Full time

Are you ready to be part of the future of healthcare? Are you able to think big, be bold, and harness the power of digital and AI to tackle longstanding life sciences challenges? Then Evinova, a new health tech business part of AstraZeneca might be for you

As the Product Director, Clinical Data Delivery, you will have ownership responsibilities of the design and delivery of innovative solutions that streamline access to clinical data for Evinova clients. You will provide thought leadership and expertise related to eCOA and digital medical device data, especially focused on the preparation of clinical data in harmony with CDISC standards. In collaboration with other study implementation team members, you will also act as a primary point of contact for clients’ data management and statistical programming teams.

  • Own the roadmap for Platform Services that automate data transformations and enable scalability of data delivery based on industry data standards (e.g., CDISC, FHIR, etc.)
  • Collaborate closely with platform and data engineering teams to deliver the Evinova Platform clinical data delivery roadmap
  • Contribute to a clinical data strategy aligned with Evinova's objectives and customer needs, considering a range of customer abilities and systems
  • Directly interact with customers, especially data management and statistical programming teams
  • Maintain knowledge of data management best practices and statistical methodologies in relevant areas to promote, investigate and implement novel approaches
  • Provide input into data-related activities associated with regulatory inspections/audits

Basic Qualifications:

  • BA/BS in Mathematics, Statistics, Computer Science, Life or Social Sciences or related field and 8+ years of experience.
  • OR MS Degree and 6+ years of industry experience
  • Experience with Digital Patient Solutions (e.g., eCOA, digital medical devices, decentralized clinical trials, etc.) in the context of clinical trials
  • Wide-ranging knowledge of CDISC data standards, industry trends, and best practices
  • Knowledge of and experience with clinical systems, including Electronic Data Capture Systems (EDC), Clinical Trial Management Systems (CTMS), etc.
  • Experience with clinical databases and other data management systems
  • Demonstrated understanding of GCP and regulatory requirements as they relate to data management systems and activities
  • Attention to detail and ability to manage concurrent projects and activities
  • Proven stakeholder management skills
  • Exemplary communication skills with the ability to consult, present, and influence effectively to clients and all seniority levels
  • Excellent decision-making and problem-solving skills with the ability to think broadly to identify and anticipate and remove potential barriers

Preferred Qualifications:

  • Statistical programming expertise within clinical drug development
  • Strong data management experience in the Biotech/Pharma/CRO industry
  • Significant product management experience and expertise
  • Familiarity and experience with FHIR data standards
  • Meticulous attention to detail to ensure data integrity, accuracy, and compliance
  • Ability to drive innovation

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.

There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all.

Are you ready to be part of a team that pushes the boundaries of science by digitally empowering a deeper understanding of the patients we’re helping?

Apply now and join us in our mission to transform healthcare and improve patients' lives

Why Evinova (AstraZeneca)?

Evinova draws on AstraZeneca’s deep experience developing novel therapeutics, informed by insights from thousands of patients and clinical researchers. Together, we can accelerate the delivery of life-changing medicines, improve the design and delivery of clinical trials for better patient experiences and outcomes, and think more holistically about patient care before, during, and after treatment. We know that regulators, healthcare professionals, and care teams at clinical trial sites do not want a fragmented approach. They do not want a future where every pharmaceutical company provides its own, different digital solutions. They want solutions that work across the sector, simplify their workload, and benefit patients broadly. By bringing our solutions to the wider healthcare community, we can help build more unified approaches to how we all develop and deploy digital technologies, better serving our teams, physicians, and ultimately patients. Evinova represents a unique opportunity to deliver meaningful outcomes with digital and AI to serve the wider healthcare community and create new standards for the sector. Join us on our journey of building a new kind of health-tech business to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting-edge methods, and bringing unexpected teams together.

Interested? Come and join our journey.

Date Posted

26-Apr-2024

Closing Date

09-May-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.