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Senior Data Standards Developer in R&D - Global Development - Denmark  

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Posted on : 28 March 2017

Project Description


Job Description
  • Do you wish to take your experience with clinical data standards to the next level and work in a highly professional, engaged and global environment bringing clinical projects to registration and market? Then you may be our new colleague.
  • In Global Development, we are responsible for managing clinical drug development worldwide, ensuring that the process lives up to uniform global standards, regulations and business ethics.
  •  We ensure medical and scientific documentation for clinical submissions and authorities and work in Global Project teams with focus on delivering viable products that make a difference to patients and ultimately benefit society.
 


About the department
  • Clinical Data Standards is a part of Clinical Operations, and our main responsibility is to develop standards for collection and reporting of clinical data and to support the use of clinical data standards from early trial design to Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM) compliant data and documentation.
  • Our department consists of 27 enthusiastic and highly engaged people working closely with multi-functional and international teams on a variety of clinical and technical projects in a pleasant and informal atmosphere.
 

The position
  • You will become part of a team dedicated to the data standards related to early trial design, protocol and planning of data collection. 
  • This entails hands-on with trial metadata, controlled terminology and global Case Report Form (CRFs) as well as interaction with the stakeholders in a complex data flow through systems and processes. 
  • As Senior Data Standards Developer, you will be involved in designing new standard CRFs, promoting frequently used trial specific CRFs to global standard, specifying global mappings of data from the point of data collection to generation of SDTM data. 
  • In addition to your focus on global data standards, you will also play an important role in the day-to-day assessments of need for trial specific solutions and ensure that these are evaluated against the global standards.
  • You will have close collaboration with primary stakeholders such as Biostatistics, Data Management, SDTM programmers and Trial Management in order to define optimal data standards to be used across clinical projects in our company.
  • Teamwork, guiding and teaching colleagues as well as continuous focus on process improvement are key elements in the job.
 



Qualifications
  • You have an B.Sc. or M.Sc. within Health and Natural Sciences or other relevant degree. 
  • Being a senior means that you bring experience with clinical trials and that you understand the impact and challenges of data standardization. 
  • Your background can be from trial management, biostatistics or data management, and we expect that you have at least three years of experience working with clinical data.
  • The preferred candidate is well versed with CDISC standards and has documented experience with standards governance and standards development.
  • You are technically strong, have an analytical approach and a demonstrated ability to understand data structures. 
  • You have high attention to detail and thrive when performing careful meticulous work.
  • You have good communication skills and navigate at ease across departments, hierarchies, and skill types. 
  • Cultural awareness and good English skills are absolutely essential, our teams are multinational and the daily work language is English
  • Additional desirable skills are experience with project management, teaching, CRF design, Oracle Clinical (OC) set-up, clinical data warehouse, Statistic Analysis System (SAS) programming, statistical analysis, and knowledge of laboratory or genetic data in clinical trials.
  • The job comes with a high degree of individual responsibility, and we expect you to be capable of working independently, taking responsibility, and showing initiative.
  • In return, we offer an interesting and challenging job with good personal development opportunities in an international atmosphere. 



Working with Us:
  • Your skills, dedication and ambition help us change lives for the better.
  • In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.