Principal Data Acquisition Standards Coordinator
We are now looking for a professional with experience in leading global clinical trial data management and strong organizational skills to work in a challenging global role based in a growing Data Science & Analytics (DS&A) team in Finland in Espoo as
PRINCIPAL DATA ACQUISITION STANDARDS COORDINATOR
YOUR TASKS AND RESPONSIBILITIES
• Create, test and maintain standards library elements, such as electronic Case Report Forms (eCRF), code lists, database, edit checks and test cases which are used for the development of study eCRFs.
• Ensure consistency across Data Acquisition / EDC (electronic data capture) libraries and standard elements
• Translate medical and technical requirements into the appropriate specifications like eCRF annotations, standard edit check specifications or standard test case definitions.
• Ensure availability of standard library content for use in all clinical studies Phase I – IV according to study start up timelines.
• Support study teams in assessing requests for new / updated standards content
• Recommend appropriate standards additions and/or modifications that would improve the collection and processing of clinical data
• Ensure all deployed library elements meet quality measures as defined in applicable data model rule books, system technical requirements and in accordance with the underlying SOPs
• Globally monitor usage and ensure adherence to established standards and functionality
• Maintain the standard library for lab analytes, units and conversion factors in the electronic data capture (EDC) system
• Manage competing priorities through effective project/time management and delegation
• Provide guidance, direction and delegate work to external staff. Perform oversight (Quality Control) and ensure timelines are met of delegated work
• Working collaboratively with global Data Acquisition & Integration (DA&I) colleagues to meet shared objectives, understanding different working cultures and present the results to the community
• Proactively identifying gaps or improvements in systems/tools and processes
• Leading functional initiatives and/or represent function in broad cross-functional initiatives and projects.
• Develop robust solutions by reaching out to necessary stakeholders and having the priorities of different stakeholders in mind
• Coaching and mentoring junior colleagues and serving as subject matter expert to peers on one or more topics
WHO YOU ARE
• University degree (Bachelor or Master) in natural sciences, statistics, computer science or a related field
• Hands-on experience with the development of electronic Case Report Forms in EDC systems like Medidata Rave, InForm or Veeva across different therapeutic areas and phases of drug development
• Knowledge of the clinical trial data management process
• Understanding the usage of medical data standards (i.e. sponsor specific or CDISC) in context of clinical trials is required
• Experience in driving global cross-functional teams with effective project management and moderation
• Customer- and results-oriented team player
• High ability and willingness to solve problems and to structure and simplify complex tasks
• Willingness to broaden skills and knowledge in order to apply it to future data collection methods.
• Strong organizational skills and able to collaborate with minimal supervision
• Fluent English skills, both spoken and written
We offer a competitive compensation, independent and challenging role in an international environment with a chance to develop your skills and experience further. To be considered for this exciting opportunity, please submit your application by Thursday February 25, 2021. Candidates will be reviewed on continuous basis.
If you feel this unique role is just what you are looking for, we are keen to hear from you! For further information, please contact Luiz Giorgiani, Head of Clinical Data Management RED II, Data Sciences & Analytics, Friday February 19, 2021 at 15.00–16.00 (EET), phone +358 400 807868.
Functional area: Clinical Development & Operations
Seniority level: Professional
Location: This position can be filled in Espoo- Finland, Reading, UK