Global Study Manager (m/f)

Vor Ort
12 MM++
Hays AG
in Central Switzerland/Swiss Plateau region
flag_no Deutschland
Katharina Tuschhoff-M?ller

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Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.

We are looking for a
Global Study Manager (m/f)

Referenz: en
Beginn: asap
Dauer: 12 MM++
Ort: in Central Switzerland/Swiss Plateau region
Branche: Chemie/Pharma

Ihre Aufgaben:
  • The Global Study Manager is a member of the Clinical Science Team and collaborates with colleagues and Clinical Trials (if applicable) to manage clinical studies - globally
  • To ensures delivery of high quality results that meet customer (internal and external) needs, on time and on budget
  • Supports Clinical Science Leader in achieving successful execution of all sponsored and investigator-initiated study activities
  • Participate in protocol conceptual phase and review
  • Management of protocol and proposal review process
  • Project/Study planning and management
  • Resource planning and management
  • Contract management, ensuring proper engagement contracts with investigators and CRO's in close collaboration with the legal department
  • Ensuring that payments of milestones and deliverables are made according to contractual agreements
  • Study Material ordering according to study agreements
  • Identifying project priorities and identifying and resolving budget and resource management issues as soon as these become apparent
  • Selecting Clinical Research Organizations (CROs) and developing and managing CRO contracts, resources, and activities for contracted out operational tasks. Identifying any issues and proposing corrective action plans.
  • Ensuring notifications and updates of the Clinical Study database
  • Delivering ongoing project updates
  • Communicating results in agreed upon formats (e.g., presentation, abstract, manuscript, etc.)
  • Maintaining agreed upon up-to-date documentation of all assigned Clinical Science work
  • Providing input into study procedures documentation, Case Report Forms and final study reports
  • Organizing study implementation and site selection with the Affiliates' staff.
  • Tracking of study progress (recruitment, documentation)
  • Follow-up on contractually agreed final study reports, publications, abstracts, and poster submissions
  • Organization and management of investigator meetings

Ihre Qualifikation
  • Masters degree in a biomedical discipline
  • Professional experience in multinational clinical study management, within the pharmaceutical industry or in a Contract Research Organization, preferably with large or multiple registration programs
  • Proven ability to identify and resolve complex clinical study design and methodology problems
  • Training experience of investigators/study site coordinators
  • Ability to build and foster global relationships
  • Ability to interface with physicians and other clinicians on an international basis
  • Excellent organization and presentation skills
  • Ability to work independently, multi tasking
  • Precise working style
  • Fluent in English and German
  • Ability to travel approximately 30% of time
  • Laboratory/Technical experience is an asset

- Clinical Project Management