Idorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Full-timeOn-siteSenior
Basel
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BEBeOne Medicines I GmbH
Clinical Research Associate(m/w/x)
Basel
from CHF 92,200 - 115,200 / year
Full-timeOn-siteJunior
Nejo AI Summary
Monitoring oncology/onco-hematology trials in a rapidly growing pharmaceutical company. BS in scientific or healthcare discipline and GCP/ICH knowledge required. Collaboration with study teams, CAPA identification.
Requirements
- BS in scientific or healthcare discipline
- Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, laptop, and iPhone
- Knowledge of GCP, ICH, and regulatory guidelines
- Monitoring experience in pharmaceutical or CRO industry (preferred)
- Experience in oncology/onco-hematology trials (preferred)
- Excellent communication and interpersonal skills
- Ability to establish and maintain effective working relationships
- Good organizational and problem-solving skills
- Ability to prioritize and multi-task
- Effective time management skills
- Written and verbal communication skills
- Good command of English language
- Good command of German language
Tasks
- Execute clinical monitoring activities
- Monitor clinical trials according to ICH, GCP, and local regulations
- Perform monitoring for oncology/onco-hematology trials
- Collaborate with Country and Regional Clinical Study Teams
- Identify and propose CAPA for gaps and improvements
- Support clinical trial start-up activities
- Complete therapeutic, protocol, and clinical research training
- Gain experience by working with experienced clinical staff
- Conduct site selection and evaluation
- Support initial site list and recruitment targets
- Provide protocol and study training to sites
- Conduct pre-study, initiation, routine monitoring, and closeout visits
- Conduct co-monitoring visits with experienced CRAs
- Create and maintain site management documentation
- Submit regular visit reports and follow-up letters
- Track regulatory submissions, recruitment, and data query resolution
- Manage site documents for TMF and ISF
- Ensure inspection readiness of the study and sites
- Establish regular communication with sites
- Report site progress, issues, and proposed actions
- Collaborate to ensure timely study milestones
- Facilitate Study Compliance Visits and site audits
- Evaluate site practices and escalate issues
- Anticipate and identify site issues
- Propose corrective and preventative actions
- Identify gaps and utilize opportunities
- Strive for operating excellence and innovation
Work Experience
- 1 year
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Outlook
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines I GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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BEBeOne Medicines I GmbH
Clinical Research Associate(m/w/x)
Basel
from CHF 92,200 - 115,200 / year
Full-timeOn-siteJunior
Nejo AI Summary
Monitoring oncology/onco-hematology trials in a rapidly growing pharmaceutical company. BS in scientific or healthcare discipline and GCP/ICH knowledge required. Collaboration with study teams, CAPA identification.
Requirements
- BS in scientific or healthcare discipline
- Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, laptop, and iPhone
- Knowledge of GCP, ICH, and regulatory guidelines
- Monitoring experience in pharmaceutical or CRO industry (preferred)
- Experience in oncology/onco-hematology trials (preferred)
- Excellent communication and interpersonal skills
- Ability to establish and maintain effective working relationships
- Good organizational and problem-solving skills
- Ability to prioritize and multi-task
- Effective time management skills
- Written and verbal communication skills
- Good command of English language
- Good command of German language
Tasks
- Execute clinical monitoring activities
- Monitor clinical trials according to ICH, GCP, and local regulations
- Perform monitoring for oncology/onco-hematology trials
- Collaborate with Country and Regional Clinical Study Teams
- Identify and propose CAPA for gaps and improvements
- Support clinical trial start-up activities
- Complete therapeutic, protocol, and clinical research training
- Gain experience by working with experienced clinical staff
- Conduct site selection and evaluation
- Support initial site list and recruitment targets
- Provide protocol and study training to sites
- Conduct pre-study, initiation, routine monitoring, and closeout visits
- Conduct co-monitoring visits with experienced CRAs
- Create and maintain site management documentation
- Submit regular visit reports and follow-up letters
- Track regulatory submissions, recruitment, and data query resolution
- Manage site documents for TMF and ISF
- Ensure inspection readiness of the study and sites
- Establish regular communication with sites
- Report site progress, issues, and proposed actions
- Collaborate to ensure timely study milestones
- Facilitate Study Compliance Visits and site audits
- Evaluate site practices and escalate issues
- Anticipate and identify site issues
- Propose corrective and preventative actions
- Identify gaps and utilize opportunities
- Strive for operating excellence and innovation
Work Experience
- 1 year
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Outlook
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines I GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
BeOne Medicines I GmbH
Industry
Pharmaceuticals
Description
The company is focused on fighting cancer and offers opportunities for scientific and business professionals.
Not a perfect match?
- Idorsia Pharmaceuticals Ltd
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Full-timeOn-siteSeniorBasel - Roche Pharma AG
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Full-timeOn-siteSeniorGrenzach - Roche
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Full-timeOn-siteJuniorBasel - Lonza
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Full-timeInternshipOn-siteBasel - Thermo Fisher Scientific
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Full-timeOn-siteExperiencedAllschwil