(+45) 29 44 00 80 / kontakt@beirholmsearch.dk

EDC System Manager

EDC System Manager
marts 26, 2019 Hanne Beirholm
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Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.

The Role

You will be responsible for the overall system strategy, management and daily operations of the EDC system (Rave), including the system role, use, configurations and processes. The position is new and you will have high influence on the global system implementation, set-up and processes and report to the VP, Head of Clinical Operations.

You will be Company subject matter expert in the clinical data-flows and systems and set up of processes (what is done where) and integrations with related systems (ePRO, IRT, Safety, 3rd party reporting (QlikSense)).

You are not necessarily system expert in Rave trial build or custom functions programming, but expert in how the system should be used and configured to support the processes and not least ask the right questions to the system and understand the vendors.

Key Accountabilities

  • Overall clinical system and data flow subject matter expert. Provide input and evaluate alternatives for decision making, etc. in how systems are used and interact.
  • Process design/detailing and requirements specifications for configuration, custom functions and standard reports.
  • Technical design of data flows and interfaces.
  • Ensure consistent and quality implementation and use of the system on trials.
  • Ensure system is kept in validated state. Lead periodic reviews, issue management, patch (risk) assessment etc.

Skills and experience

Extensive experience and in depth understanding of clinical data processes, data flow and clinical data systems and associated business and regulatory requirements.

Including as much as possible of:

  • EDC workflows and configurations
  • Set-up and use of standard libraries
  • Data cleaning processes and steps / levels
  • Reports (for Status management, workflow support etc)
  • Data interchange (methods, technology)
  • Embedded SAE forms and integration with Safety systems
  • Methods and technology for loading 3rd party data, including complex biomarker data from a variety of sources.
  • Randomization, cohort management and IMP allocation.
  • In depth experience with IRT a plus

Besides all the technical and educational requirements, we need a person with strong communication skills, for strategic / decision making communication with cross functional stakeholders as well as technical experts.

You hold a holistic understanding of the overall dataflow in clinical trials, capability to extend that understanding into complex oncology trials, with a variety of external data and a highly dataflow and to new situations. Adaptability for changing needs, changed plans and capability to handle a series of parallel tasks and discussions.

Other

Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.

Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.

 

If you would like additional information about this position before applying using the link, please contact Beirholm Search, Hanne Beirholm tel. 29 44 00 80





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