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Trial Operations Manager
Eingestellt von RM IT Professional Resources AG
Gesuchte Skills: Client, Design
Projektbeschreibung
Trial Operations Manager wanted for our Basel based client in the pharmaceutical sector.
YOUR EXPERIENCE/SKILLS:
- College or university degree with significant life science experience and at least 5 years' experience in clinical research, in planning/executing and/or monitoring clinical trials
- Solid understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, project management and operations
- Project and Trial management as well as CRA and Clinical Study Managers experience would be advantageous
- Excellent knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authorities (FDA/EMEA), local/National health authorities regulations and clinical development process
- Languages: fluent English both written and spoken
YOUR TASKS:
- Leading trial allocation process to ensure adequate patient accessibility and alignment with Regional and Country strategies, including re-allocation or corrective action when needed
- Providing ongoing information and regular updates to the Trial Monitoring organization, including remediation actions
- Reviewing, approving, and ensuring updates to CCGs as appropriate during trial conduct
- Performing User Acceptance Testing (UAT) for EDC system
- Contributing to the development of the DHP and DRP
- Supporting inspection readiness and submission preparation for monitoring related activities
START: ASAP
DURATION: 12MM+
LOCATION: Basel, Switzerland
REF.NR.: BH10924
Please feel free to reach out to the Account Manager, Zahira Wyler.
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
NEW TO SWITZERLAND? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more
YOUR EXPERIENCE/SKILLS:
- College or university degree with significant life science experience and at least 5 years' experience in clinical research, in planning/executing and/or monitoring clinical trials
- Solid understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, project management and operations
- Project and Trial management as well as CRA and Clinical Study Managers experience would be advantageous
- Excellent knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authorities (FDA/EMEA), local/National health authorities regulations and clinical development process
- Languages: fluent English both written and spoken
YOUR TASKS:
- Leading trial allocation process to ensure adequate patient accessibility and alignment with Regional and Country strategies, including re-allocation or corrective action when needed
- Providing ongoing information and regular updates to the Trial Monitoring organization, including remediation actions
- Reviewing, approving, and ensuring updates to CCGs as appropriate during trial conduct
- Performing User Acceptance Testing (UAT) for EDC system
- Contributing to the development of the DHP and DRP
- Supporting inspection readiness and submission preparation for monitoring related activities
START: ASAP
DURATION: 12MM+
LOCATION: Basel, Switzerland
REF.NR.: BH10924
Please feel free to reach out to the Account Manager, Zahira Wyler.
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
NEW TO SWITZERLAND? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Medien/Design