Clinical Trial Manager Pase II/III (m/f)

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 Trial Manager Pase II/III (m/f)

Referenz: -en
Beginn: 04/10
Dauer: 12 MM
Ort: in Switzerland
Branche: Großhandel mit 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.Regional Study Team Level:
• 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)
• Additional qualification for Sr. CTM o Regional clinical trial management experience is preferred o Management complex global study (e.g. Large Phase III studies, difficult patient populations, CRO involvement) o Ability to deal with difficult situations and propose solutions o Ability to lead by example and encourage team members to seek solutions o Ability to handle multiple competing priorities and utilize resources effectively

Skills:
- Clinical Project Management


Keywords: Clinical trial Manager CTM CTPM GCP ICH Phase II Phase III