Regulatory & Study Start-Up Specialist - office based in Frankfurt or Freiburg/Br
QuintilesIMS
Frankfurt, DE
vor 5 Tg.

RESPONSIBILITIES

  • Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST.
  • Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines.

    Where applicable, act as a Country Lead for projects with no regional Lead assigned.

  • Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
  • Review, prepare and negotiate site contracts and budgets with sites.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • Distribute completed documents to sites and internal project team members.
  • Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics ICF and IP Release documents, in line with project timelines.
  • Perform quality control of documents provided by sites.
  • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
  • Ensure regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
  • Review and provide feedback to management on site performance metrics.
  • Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines.
  • Ensure monitoring measures are in place and implement contingency plan as needed.

  • May contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
  • Assist in pre-award activities including bid defenses, proposals and oversights of the scope of work at country level.
  • May act as Local Regulatory, Ethics and Contract Expert and reviewer of ICF.
  • May act as mentor, and prepare and deliver country-specific training, for less experienced staff.
  • REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Effective communication, organizational and planning skills
  • Ability to work independently and to effectively prioritize tasks
  • Ability to work on multiple projects
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Fluent languages skills in German and good command of English.
  • MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s Degree or apprenticeship in life science or a combination of education and experience; or a background in law or economics and contracting experience.
  • For a Junior Specialist position at least a training in clinical research or law; for a Specialist role at least 3 years of regulatory start-up / submission experience, for a Senior Specialist position at least 5 years of experience.
  • Bewerben
    Zu Favoriten hinzufügen
    Aus Favoriten entfernen
    Bewerben
    E-Mail
    Wenn ich auf "Fortfahren" klicke, gebe ich neuvoo das Einverständnis, meine Informationen zu speichern und mir wie in den Nutzungsbedingungen und Datenschutzbestimmungen beschrieben, personalisierte E-Mail Alerts zu schicken.
    Fortfahren
    Bewerbungsformular