Clinical Project Manager (m/f)

in Switzerland  ‐ Vor Ort
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Schlagworte

Beschreibung

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
Clinical Project Manager (m/f)

Referenz: -en
Beginn: 06/10
Dauer: 12 MM+
Ort: in Switzerland
Branche: Herstellung von pharmazeutischen Erzeugnissen

Ihre Aufgaben:
  • Drive the successful execution of a protocol in a country and/or region from study start up to archiving of the regulatory documents
  • Interact with the regional operations team to ensure timelines, deliverables and data quality are met within budget at the regional protocol level
  • Handle multiple competing priorities and utilize resources effectively at the regional protocol level
  • Provide mentoring guidance, coaching and feedback to the regional team
  • Lead regional operation trial by ensuring the team is adhering to local regulations and SOPs
  • Define and ensure local timelines, deliverables and data quality are met within budget at the regional
  • protocol level
  • Lead monitoring and regional operations meetings for the protocol
  • Core Member of Clinical Trial Team and Global Operations Teams
  • Manage the ROM/RMs within assigned regions for protocol specific activities
  • Identify short term resource needs and manage resolutions with the CTPM
  • Provide protocol specific training and guidance to regional internal operation team
  • Develop, review and/or provide input into study documents (e.g., monitoring guidelines, CRF instructions
  • and study budget template)
  • Accountable for facilitating, tracking and monitoring the progress of assigned site activities
  • Plan, set-up and manage the regional trial communication plan, including investigator, monitor and
  • operational team meeting schedules, overall drug supply and management and provision of other study materials in accordance with project and study levels plans
  • Manage/execute regional operations activities including, but not limiting to country/site feasibility,
  • investigator meeting planning, study and site start up, site management, database lock activities, site closure and TMF archiving
  • Manage the regional regulatory document approval process
  • Liaise with ROMs/RMs to ensure that local health authorities, EC/IRB submissions are completed in a timely
  • fashion


Ihre Qualifikation
  • University degree in either a biological science or healthcare profession
  • In-depth clinical research experience
  • Management of local/less complex studies (e.g. Phase II, small Phase III/IIIb studies, open label studies)
  • Monitoring experience required
  • Understanding of the drug development process
  • Understanding of ICH guidelines and GCP
  • Advanced computer skills
  • Effective oral and written communication skills
  • Fluent in English (additional languages advantageous)



Skills:
- Clinical Project Management


Keywords: CTM and CPM and "Clinical trial Manager" and "Clinical project manager"
Start
06/10
Dauer
12 MM+
(Verlängerung möglich)
Von
Hays AG
Eingestellt
12.05.2010
Ansprechpartner:
Katharina Tuschhoff-M?ller
Projekt-ID:
151146
Vertragsart
Freiberuflich
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