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Associate Director, Site Start Up and Maintenance(m/w/x)
Strategic planning for global site regulatory activities in novel specialty pharmaceutical clinical trials. 8+ years in Clinical Operations with 5+ years direct site management oversight required. Mentorship for assigned staff, global regulatory focus.
Anforderungen
- BS degree or international equivalent in life science
- Extensive experience (≥ 8 years) in Clinical Operations, Project Management, study start-up, site budgeting and contracting, or trial optimization
- More than 5 years of direct responsibility in site management and oversight of clinical research studies
- Expertise in clinical trial regulations and ethics committee submissions
- Expertise in site contract and budget amendments administration
- Expertise with leading edge trial optimization vendors, tools, and methods
- Experience in line management and working in a matrix environment
- Proficiency with software models and database structures
- Expertise in principles driving site maintenance strategies including site contract amendments
- Direct experience in the pharmaceutical industry or related field
- Ability to demonstrate, interpret, explain, represent, and drive unbiased data insights into clinical trials operational delivery
- Ability to develop deep insights, uncover unmet needs, drive innovation, inspire, develop, collaborate and lead within a global matrixed team
- Ability to explain data and facilitate decision making processes to be data driven
Aufgaben
- Oversee strategic planning for global site regulatory activities
- Manage budgeting and contracting maintenance tasks
- Collaborate with internal and external stakeholders
- Provide guidance and mentorship to assigned staff
- Analyze clinical trial intelligence data for resource forecasting
- Support priority projects through study closure
- Champion innovative processes and methodologies for site services
- Partner with CROs and Clinical Operations teams to improve metrics
- Train Site Start Up and Maintenance Teams on efficient planning
- Ensure consistent standards across project portfolios
- Drive implementation of solutions to enhance site maintenance
- Leverage industry tools for timeline and performance data
- Monitor adherence to deliverables at country and site levels
- Lead cross-functional site maintenance teams
- Serve as a point of escalation for issue resolution
- Model Takeda’s values in all interactions
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
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- Takeda Pharmaceuticals International AGVollzeitnur vor OrtSeniorZürich
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Associate Director, Site Start Up and Maintenance(m/w/x)
Strategic planning for global site regulatory activities in novel specialty pharmaceutical clinical trials. 8+ years in Clinical Operations with 5+ years direct site management oversight required. Mentorship for assigned staff, global regulatory focus.
Anforderungen
- BS degree or international equivalent in life science
- Extensive experience (≥ 8 years) in Clinical Operations, Project Management, study start-up, site budgeting and contracting, or trial optimization
- More than 5 years of direct responsibility in site management and oversight of clinical research studies
- Expertise in clinical trial regulations and ethics committee submissions
- Expertise in site contract and budget amendments administration
- Expertise with leading edge trial optimization vendors, tools, and methods
- Experience in line management and working in a matrix environment
- Proficiency with software models and database structures
- Expertise in principles driving site maintenance strategies including site contract amendments
- Direct experience in the pharmaceutical industry or related field
- Ability to demonstrate, interpret, explain, represent, and drive unbiased data insights into clinical trials operational delivery
- Ability to develop deep insights, uncover unmet needs, drive innovation, inspire, develop, collaborate and lead within a global matrixed team
- Ability to explain data and facilitate decision making processes to be data driven
Aufgaben
- Oversee strategic planning for global site regulatory activities
- Manage budgeting and contracting maintenance tasks
- Collaborate with internal and external stakeholders
- Provide guidance and mentorship to assigned staff
- Analyze clinical trial intelligence data for resource forecasting
- Support priority projects through study closure
- Champion innovative processes and methodologies for site services
- Partner with CROs and Clinical Operations teams to improve metrics
- Train Site Start Up and Maintenance Teams on efficient planning
- Ensure consistent standards across project portfolios
- Drive implementation of solutions to enhance site maintenance
- Leverage industry tools for timeline and performance data
- Monitor adherence to deliverables at country and site levels
- Lead cross-functional site maintenance teams
- Serve as a point of escalation for issue resolution
- Model Takeda’s values in all interactions
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Über das Unternehmen
Takeda Pharmaceuticals International AG
Branche
Pharmaceuticals
Beschreibung
The company is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
Noch nicht perfekt?
- Takeda Pharmaceuticals International AG
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Associate Director, Biostatistics(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg - Takeda Pharmaceuticals International AG
Global Real Estate Lead(m/w/x)
Vollzeitnur vor OrtSeniorZürich - CSL Behring
Senior Director Global Clinical Program Lead Cardiovascular & Renal(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg