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Senior Clinical Research Scientist(m/w/x)
Overseeing Medical Data Review Plan execution and developing trial strategy for late-stage clinical development at a global pharma company. Extensive late-stage clinical development experience required; Advanced Clinical/Science Degree preferred. Work across cross-functional teams in a global pharma setting.
Anforderungen
- Bachelor’s degree in life sciences
- Advanced Clinical/Science Degree preferred
- Extensive academic or industry experience in late stage clinical development
- Strong knowledge of GCP, ICH, FDA, EMA guidelines
- In-depth knowledge of cross-functional teams in drug development
- Proven track record in a fast-paced, matrix environment
- Experience with Study Management Team (SMT)
- Experience as co-lead with various stakeholders
- Experience leading and mentoring others
- Experience solving unique or unpredictable problems
- Ability to partner across diverse regions and cultures
- Strong verbal communication and influencing skills
Aufgaben
- Oversee Medical Data Review Plan execution
- Manage database lock and data interpretation
- Ensure effective execution of the Clinical Development Plan
- Develop trial and protocol strategy within the broader CDP
- Ensure appropriate data is reflected in protocols, ICFs, and CSR
- Establish clinical science strategy for CTA/EC submissions
- Prepare briefing packs and responses to health authority questions
- Collaborate with filing team and stakeholders on CDP context
- Act independently with investigators and oversee investigator meetings
- Contribute to Therapeutic Area Expert interactions for clinical program optimization
- Manage relationships with external partnerships and institutions
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
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Senior Clinical Research Scientist(m/w/x)
Overseeing Medical Data Review Plan execution and developing trial strategy for late-stage clinical development at a global pharma company. Extensive late-stage clinical development experience required; Advanced Clinical/Science Degree preferred. Work across cross-functional teams in a global pharma setting.
Anforderungen
- Bachelor’s degree in life sciences
- Advanced Clinical/Science Degree preferred
- Extensive academic or industry experience in late stage clinical development
- Strong knowledge of GCP, ICH, FDA, EMA guidelines
- In-depth knowledge of cross-functional teams in drug development
- Proven track record in a fast-paced, matrix environment
- Experience with Study Management Team (SMT)
- Experience as co-lead with various stakeholders
- Experience leading and mentoring others
- Experience solving unique or unpredictable problems
- Ability to partner across diverse regions and cultures
- Strong verbal communication and influencing skills
Aufgaben
- Oversee Medical Data Review Plan execution
- Manage database lock and data interpretation
- Ensure effective execution of the Clinical Development Plan
- Develop trial and protocol strategy within the broader CDP
- Ensure appropriate data is reflected in protocols, ICFs, and CSR
- Establish clinical science strategy for CTA/EC submissions
- Prepare briefing packs and responses to health authority questions
- Collaborate with filing team and stakeholders on CDP context
- Act independently with investigators and oversee investigator meetings
- Contribute to Therapeutic Area Expert interactions for clinical program optimization
- Manage relationships with external partnerships and institutions
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Über das Unternehmen
1201 F. Hoffmann-La Roche AG
Branche
Healthcare
Beschreibung
Roche is dedicated to advancing science and ensuring access to healthcare for everyone, with over 100,000 employees globally.
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