Clinical Study Manager 60-80%

Universitätsspital Basel

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  • Veröffentlicht:

    14 Dezember 2023
  • Pensum:

    60 – 80%
  • Vertrag:

    Festanstellung
  • Arbeitsort:

    Basel Universitätsspital

Clinical Study Manager 60-80%

Aufgaben


  • Plan, establish, conduct, and document external national and global clinical studies (Phase I-IV) in the Dermatology Department, following Good Clinical Practice (GCP) guidelines.

  • Supervise and oversee academic and internal Investigator-Initiated Trials on a global scale.

  • Develop and implement new Investigator-Initiated Trials (IITs) and associated documents, in consultation with the Principal Investigator.

  • Manage projects, including planning, strategy, optimization, cost control, and reporting.

  • Coordinate submission procedures with authorities and ethics committees (Ethics Committee, Swissmedic).

  • Perform feasibility assessments and select sites for clinical trials.

  • Lead the planning and execution of trial recruitment and enrollment strategies.

  • Collaborate with external vendors (such as CROs) and service providers for trial-related activities.

  • Monitor and manage trial progress and milestones.

  • Manage trial budgets and resources.

  • Handle data management, monitoring, and analysis of trial data.

  • Prepare and take responsibility for studies, including monitoring visits.

  • Manage relationships with key opinion leaders and scientific advisory boards.

  • Contribute to the revision and expansion of Standard Operating Procedures (SOPs).

Profil


  • University degree (BSc or MSc in Biology, Biomedicine, Biochemistry or Pharmacy).

  • At least 5 years of professional experience as a Global Clinical Study Manager.

  • Current knowledge of the regulatory environment in Switzerland.

  • Very good knowledge of English language in spoken and written form, good knowledge of German and French.

  • Accurate, conscientious and goal-oriented working style and high sense of responsibility and quality awareness as well as high social competence.

  • Assertiveness and organizational talent, strong team and communication skills, resilience and the ability to act proactively.

  • Enjoyment in close collaboration with various professional groups and disciplines.

  • Service orientation and pronounced teamwork; open, appreciative communication.

Benefits

Fragen zur Stelle?

myrna.afeche@usb.ch


Kontakt

  • Universitätsspital Basel

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