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Associate Director EDC (Rave) Strategy Lead

Location Mississauga, Ontario, Canada Barcelona, Catalonia, Spain Dublin, Leinster, Ireland Job ID R-201193 Date posted 28/06/2024

This is what you will do:

  • As an Associate Director, EDC (Rave) Strategy Lead, within our Clinical Data Management (CDM) division, your responsibilities will revolve around leading or contributing to Clinical Data Management (CDM) strategies. You'll be tasked with leading and successfully delivering complex studies or projects, while also engaging with external partners. Your proactive approach to sharing insights and experiences with colleagues, both within and outside the department, is crucial. Your role involves overseeing various tasks and implementing process improvements to guarantee the accuracy, completeness, and compliance of data crucial for publications and regulatory submissions. Your involvement in shaping technical landscapes, business strategies, and healthcare environments through contributions to various initiatives is integral.
  • The EDC Rave Strategy Lead is responsible for setting the strategic direction for EDC implementation and for defining and implementing EDC technology solutions in line with the business need and strategic direction of the company. As the Medidata platform expert this individual is accountable for driving the delivery of operational processes, technology solutions and services that meet the needs of the business and enable efficient delivery of clinical studies.

You will be responsible for:

  • Set the strategic direction for EDC implementation at Alexion, ensuring alignment with overall business needs and strategic direction.
  • Provide system expertise and superuser role in the key components and functionality of the Medidata platform, providing technical expertise and recommendations from study start up through study closure.
  • Define best practices and implement robust processes to effectively work within the Medidata platform.
  • Evaluate system upgrades or new functionality on the Medidata platform, determining the risk and impact of implementing these changes.
  • Support the roll out of new functionality or Medidata products, ensuring they are embedded effectively into Alexion processes.
  • Point of contact and escalation point for Medidata system issues, working closely with Medidata to resolve issues as soon as possible.
  • Provide oversight and support of any Rave programming activities outsourced to CROs. Define and monitor key performance indicators to evaluate the overall performance.
  • Serve as CDMS subject matter expert on regulatory audits and inspections.
  • Assist in identifying sources of new Data Management technologies and/or systems to meet corporate goals and business strategies. 

You will need to have:

  • Bachelor’s degree with 8-10 years of experience working with clinical trial technologies.
  • Extensive Medidata platform knowledge including Rave, Coder, Rave Safety Gateway, tSDV, Cloud Admin and RWS.
  • Ability to define and lead improvement, innovation projects and interact with internal and external stakeholders at senior levels of management.
  • Excellent communication skills in both written and spoken English with an a ability to interpret and communicate technical information into business language.
  • High proficiency with technology associated with current and evolving data management practices in electronic data capture.
  • Strong ability to solve complex, abstract problems in cross-functional business collaboration and independent projects while demonstrating proactive drive, sound decision-making, and attention to detail.
  • The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

  • Strong knowledge of emerging, innovative technologies in clinical trial management.
  • Experience of working in a global organization with complex/ geographical context.
  • Experience of agile working practices and a good understanding of project management techniques and methods.
  • Knowledge of the end-to-end clinical trial process.
  • Extensive technical/industry experience.

Working Environment:

  • Hybrid Working Model.
  • Collaborative global team environment with a focus on innovation and continuous improvement.
  • May require occasional travel.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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