Clinical Documentation Systems Specialist (eSource)

Akkodis

  • Nederland
  • Vast
  • Voltijds
  • 1 dag geleden
We are looking for a Clinical Documentation Systems Specialist (eSource), Fulltime, 40 hours a week, to join our Akkodis team.📍 Location: Achterhoek area🏡 Hybrid: Remote, with travel to the Achterhoek area 1-2 times per month (if required)📋 Contract: 1 year (this is initially temporary position for 12 months, with the possibility to be extended).Job Overview:The Clinical Documentation Systems Specialist (eSource) will play a critical role in designing and configuring electronic source forms that are utilized in clinical trials. Working closely with internal stakeholders, the specialist will be responsible for creating clinical trial source form templates and configuring these source forms electronically within the eSource system.The most important tasks:
  • Review research protocols, CRF guidelines, and other stakeholder specifications to create accurate, comprehensive source form (CRF) templates.
  • Develop electronic forms from stakeholder specifications and feedback.
  • Build, test, and publish electronic forms to maintain quality of the form design.
  • Conduct and document thorough QA of source form templates.
  • Act as a liaison between end-users and vendors to be able to suggest improvements to enhance the form builder's capabilities.
  • Collaborate with cross-functional teams to ensure successful execution of projects.
  • Support and coordinate user acceptance testing.
  • Develop, document, and implement best practices/SOPs for standardization, QA, and process improvement around source form creation and digitization.
  • Provide mentorship, training, and support to more junior team members to ensure collaboration and consistency across the team and to provide subject matter expertise.
Requirements to properly perform in this role:
  • Prior experience with Electronic Data Capture (EDC) systems to ensure proper data flow from eSource.
  • Awareness of CDISC standards (CDASH and SDTM) for seamless eSource to EDC integration.
  • Understanding of the Operational Data Model (ODM) to facilitate data exchange and mapping.
  • Experience working directly with clients (internal and/or external) and championing their long-term success..
  • Prior experience with a CTMS or other clinical research software tool is preferred.
|||CompanyDetail|||Akkodis is a specialized IT & Engineering consultancy with over 30 years' experience providing consultants to our key partners, globally and in The Netherlands. Currently, we are recruiting a Clinical Documentation Systems Specialist (eSource). This person will be assigned to a project at one of our clients, located in Achterhoek Area. |||CompanyDetail-endCandidateProfile|||Job requirements:
  • Education: Bachelor's degree in computer science, IT, Biological Sciences, or a related field, or a combination or relevant experience and education.
  • Experience: 3+ years of clinical research experience, including experience creating and/or QAing source document templates (CRFs).
Are you interested in this challenge, or do you want to come in touch?Please contact your Talent Acquisition Specialist or apply via . |||CandidateProfile-end|||

Akkodis