Records Management Specialist

Posted 2 weeks ago

We are looking for a Records Management Specialist.

Job Description

  • Review of Clinical trial files for accuracy, completeness and ensure TMF inspection ready
  • Preparation, handling, distribution, filing, and archiving of clinical trials documentation according to the scope of work and standard operating procedures
  • Provide training and support to systems users (such as CTMS, eTMF)

Requirements

  • 1 year of experience in similar position in well-established CRO, pharmaceutical, medical device company or 1 year of experience as a Study coordinator – significant advantage
  • Awareness of knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, TMF RM – required
  • Knowledge of regulatory requirements in the EU, APAC, East-Europe and south-America regions- significant advantage
  • BSc/BA diploma or equivalent
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
  • Ability to prioritize, self-control and diligence in completing big demanding projects
  • Strong written and verbal communication skills including good command of English language
  • Effective time management and organizational skills
  • Permanent attention to details, accuracy in work
  • Ability to establish and maintain effective working relationships with coworkers, managers and vendors

Apply Online