Debiopharm
Head of Biostatistics & Data Management(m/w/x)
Full-timeOn-siteSenior
Lausanne
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DEDebiopharm
Senior Trial Master File (TMF) Specialist(m/w/x)
Lausanne
Full-timeOn-siteSenior
Nejo AI Summary
Managing TMF documentation and eTMF system support for oncology and infectious disease therapies. At least 3 years in pharma with TMF experience required. Equal-pay certified, inclusive workplace.
Requirements
- Bachelor's or Master's degree in Science, Healthcare, or equivalent experience
- At least 3 years in pharmaceutical industry
- Hands-on experience in clinical trials
- Hands-on experience in TMF documentation/systems
- Solid knowledge of Good Clinical Practice (GCP)
- Advanced proficiency managing digital clinical systems
- Fluent English
- Proficiency in French or another European language
- Strong communication skills
- Team leadership skills
- Ability to build effective relationships
- High organization skills
- Detail-oriented
- Excel at planning
Tasks
- Guard Trial Master Files
- Support Clinical Trial Teams
- Ensure documentation compliance
- Serve as Clinical Business Administrator
- Provide eTMF system support
- Contribute to validation activities
- Implement risk-based quality reviews
- Oversee TMF completeness
- Establish KPIs
- Report on TMF quality
- Support teams during audits
- Support teams during inspections
- Support due diligence activities
- Identify improvement opportunities
- Drive cross-functional initiatives
- Contribute to SOP evolution
- Contribute to training tool development
- Provide ongoing training
- Guide team members
- Build global awareness of TMF requirements
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Fluent
- French – Basic
- OTHER_EUROPEAN – Basic
Tools & Technologies
- TMF documentation/systems
- digital clinical systems
Benefits
Other Benefits
- Equal-Pay certified workplace
Informal Culture
- Inclusive and respectful workplace
Purpose-Driven Work
- Culture that values people, purpose, and performance
Startup Environment
- Opportunity to grow, share, and shape the future of healthcare
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Debiopharm 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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DEDebiopharm
Senior Trial Master File (TMF) Specialist(m/w/x)
Lausanne
Full-timeOn-siteSenior
Nejo AI Summary
Managing TMF documentation and eTMF system support for oncology and infectious disease therapies. At least 3 years in pharma with TMF experience required. Equal-pay certified, inclusive workplace.
Requirements
- Bachelor's or Master's degree in Science, Healthcare, or equivalent experience
- At least 3 years in pharmaceutical industry
- Hands-on experience in clinical trials
- Hands-on experience in TMF documentation/systems
- Solid knowledge of Good Clinical Practice (GCP)
- Advanced proficiency managing digital clinical systems
- Fluent English
- Proficiency in French or another European language
- Strong communication skills
- Team leadership skills
- Ability to build effective relationships
- High organization skills
- Detail-oriented
- Excel at planning
Tasks
- Guard Trial Master Files
- Support Clinical Trial Teams
- Ensure documentation compliance
- Serve as Clinical Business Administrator
- Provide eTMF system support
- Contribute to validation activities
- Implement risk-based quality reviews
- Oversee TMF completeness
- Establish KPIs
- Report on TMF quality
- Support teams during audits
- Support teams during inspections
- Support due diligence activities
- Identify improvement opportunities
- Drive cross-functional initiatives
- Contribute to SOP evolution
- Contribute to training tool development
- Provide ongoing training
- Guide team members
- Build global awareness of TMF requirements
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Fluent
- French – Basic
- OTHER_EUROPEAN – Basic
Tools & Technologies
- TMF documentation/systems
- digital clinical systems
Benefits
Other Benefits
- Equal-Pay certified workplace
Informal Culture
- Inclusive and respectful workplace
Purpose-Driven Work
- Culture that values people, purpose, and performance
Startup Environment
- Opportunity to grow, share, and shape the future of healthcare
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Debiopharm 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.
About the Company
Debiopharm
Industry
Pharmaceuticals
Description
Debiopharm is a privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases to improve patient outcomes and quality of life.
Not a perfect match?
- Debiopharm
Head of Biostatistics & Data Management(m/w/x)
Full-timeOn-siteSeniorLausanne - SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Full-timeOn-siteExperiencedTolochenaz, Lausannefrom CHF 144,000 / year - SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Full-timeOn-siteExperiencedLausannefrom CHF 144,000 / year - SHQ Medtronic Int. Trading Sàrl
Regulatory Affairs Specialist(m/w/x)
Full-timeOn-siteExperiencedLausanne