Regulatory Sr Clin Ops Specialist_Madrid
Syneos Health
, Hernani, Calle, Madrid, ESP, Europe , Spain
hace 3 días


The position is responsible for providing clerical,technical and administrative support to one or more business units or clientswithin Clinical Operations.

Provides overall study support to functional leadsto ensure the successful completion of project deliverables. Mentors and / ortrains less experienced staff.


  • Responsible for performing activities in compliancewith applicable Corporate and Clinical Operations Policies, Standard OperatingProcedures and Work Instructions
  • Assists Clinical Monitoring staff with sitemanagement activities, including serving as a Sponsor representative for siteson assigned studies, and communicating with sites to ensure compliance withprotocol requirements, study procedures and relevant guidelines
  • Creates and assists with maintenance of projectfiles, handles project correspondence
  • Participates in file audits
  • Prepares and maintains site manuals, referencetools and other documents
  • Maintains, updates, and inputs clinical trackinginformation into databases
  • Tracks incoming and outgoing clinical andregulatory documents and updates for investigator sites, studies, project team,or client
  • Manages shared mailbox, processes site requests androutes correspondence appropriately
  • Coordinates the ordering, packaging, shipping andtracking of site supplies and materials
  • Assists with coordination of team meetings, attendsmeetings and prepares accurate meeting minutes and action items
  • Routinely anticipates, identifies and resolvespotential issues and implements corrective actions, seeking guidance as neededto resolve more complex issues
  • Maintains overall awareness in the field ofclinical research, as well as assigned areas, by completing all necessary andassigned training.
  • May provide training or mentorship to more juniorlevel Clinical Operations Specialists (COS).
  • Qualifications

    QUALIFICATION REQUIREMENTS (pleaseindicate if preferred’)

  • Associates degree preferred orequivalent
  • Experience in clinicalresearch / pharma / biotech or related field considered in lieu of degree
  • Good knowledge of medical terminology,clinical data, and ICH / GCP preferred
  • Ability to successfully prioritize andwork on multiple tasks
  • Strong attention to detail, accuracyand organizational skills
  • Excellent communication, presentation,and interpersonal skills
  • Ability to embrace new technologies
  • Minimal travel up to 10% may be required
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