ICON plc
Clinical Research Associate II / Senior Clinical Research Associate Biotech(m/w/x)
Full-timeWith HomeofficeSenior
Frankfurt am Main
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MEMerz Therapeutics
Senior Clinical IT & Data Oversight Manager(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeSenior
Data Science
Nejo AI Summary
Overseeing clinical IT systems and data integrity for pharmaceutical trials, ensuring GxP and GDPR compliance. 3 years of IT system qualification in GCP-regulated environments required. Hybrid work, individual career development.
Requirements
- Academic degree in data science or IT/computer science
- 3 years of experience in IT systems setup/qualification in GCP-regulated environment
- 3–4 years of experience in Clinical Data Management
- Understanding of GCP requirements for IT systems
- Experience with clinical trial systems (e.g., EDC, IRT, eCRF, eCOA, CTMS, eTMF)
- Fluent English (written and spoken)
- Strong understanding of IT and data processes
- Programming knowledge (e.g., SAS, SQL, Python)
- Hands-on programming experience
- Strong communication skills
- Well-organized
- Reliability
- Proactive mindset
- Collaborative mindset
- Interest in IT topics
- Interest in clinical development
- Motivation to own and develop procedures and tools
Tasks
- Track and oversee clinical IT systems
- Ensure compliance with GxP, GDPR, FDA 21 CFR Part 11
- Support audits, risk assessments, and system evaluations
- Coordinate system updates and change management
- Manage decommissioning and issue resolution
- Support data transfer and interface validation
- Optimize clinical data workflows with Clinical Data Management
- Contribute to sponsor data quality oversight
- Conduct critical data review and trend analysis
- Use data analytics and visualization tools (SAS, SQL, Python, Power BI)
- Support documentation processes
- Identify, transfer, and archive essential documents
- Drive cross-functional collaboration
- Train on compliance expectations
- Participate in audits and budget planning
- Evaluate and implement new digital tools
Work Experience
- 3 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- GCP
- EDC
- IRT
- eCRF
- eCOA
- CTMS
- eTMF
- SAS
- SQL
- Python
Benefits
Career Advancement
- Individual career development
Flexible Working
- Hybrid work model
Family Support
- Good work-life balance
Other Benefits
- Attractive location
Parking & Commuter Benefits
- Good transport links
Modern Office
- Modern workplaces
Free or Subsidized Food
- Company restaurants
Informal Culture
- International family business
- Flat hierarchies
- Open, appreciative corporate culture
Competitive Pay
- Attractive remuneration
Additional Allowances
- Extensive social benefits
Healthcare & Fitness
- WellPass
Public Transport Subsidies
- Germany ticket
Corporate Discounts
- Corporate Benefits
Company Bike
- JobBike
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Merz Therapeutics 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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MEMerz Therapeutics
Senior Clinical IT & Data Oversight Manager(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeSenior
Data Science
Nejo AI Summary
Overseeing clinical IT systems and data integrity for pharmaceutical trials, ensuring GxP and GDPR compliance. 3 years of IT system qualification in GCP-regulated environments required. Hybrid work, individual career development.
Requirements
- Academic degree in data science or IT/computer science
- 3 years of experience in IT systems setup/qualification in GCP-regulated environment
- 3–4 years of experience in Clinical Data Management
- Understanding of GCP requirements for IT systems
- Experience with clinical trial systems (e.g., EDC, IRT, eCRF, eCOA, CTMS, eTMF)
- Fluent English (written and spoken)
- Strong understanding of IT and data processes
- Programming knowledge (e.g., SAS, SQL, Python)
- Hands-on programming experience
- Strong communication skills
- Well-organized
- Reliability
- Proactive mindset
- Collaborative mindset
- Interest in IT topics
- Interest in clinical development
- Motivation to own and develop procedures and tools
Tasks
- Track and oversee clinical IT systems
- Ensure compliance with GxP, GDPR, FDA 21 CFR Part 11
- Support audits, risk assessments, and system evaluations
- Coordinate system updates and change management
- Manage decommissioning and issue resolution
- Support data transfer and interface validation
- Optimize clinical data workflows with Clinical Data Management
- Contribute to sponsor data quality oversight
- Conduct critical data review and trend analysis
- Use data analytics and visualization tools (SAS, SQL, Python, Power BI)
- Support documentation processes
- Identify, transfer, and archive essential documents
- Drive cross-functional collaboration
- Train on compliance expectations
- Participate in audits and budget planning
- Evaluate and implement new digital tools
Work Experience
- 3 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- GCP
- EDC
- IRT
- eCRF
- eCOA
- CTMS
- eTMF
- SAS
- SQL
- Python
Benefits
Career Advancement
- Individual career development
Flexible Working
- Hybrid work model
Family Support
- Good work-life balance
Other Benefits
- Attractive location
Parking & Commuter Benefits
- Good transport links
Modern Office
- Modern workplaces
Free or Subsidized Food
- Company restaurants
Informal Culture
- International family business
- Flat hierarchies
- Open, appreciative corporate culture
Competitive Pay
- Attractive remuneration
Additional Allowances
- Extensive social benefits
Healthcare & Fitness
- WellPass
Public Transport Subsidies
- Germany ticket
Corporate Discounts
- Corporate Benefits
Company Bike
- JobBike
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Merz Therapeutics 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
Merz Therapeutics
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein führendes Pharma-Unternehmen, das Menschen mit Bewegungsstörungen und anderen gesundheitlichen Beschwerden hilft.
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