BeOne Medicines I GmbH
Associate Director, Regional Program Lead(m/w/x)
Vollzeitnur vor OrtManagement
Basel
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BEBeOne Medicines I GmbH
Regional Clinical Study Manager(m/w/x)
Basel
ab CHF 124.800 - 156.000 / Jahr
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Managing regional clinical operations for oncology studies, leading cross-functional teams and external partners. 4+ years progressive clinical research experience required. Collaboration with key stakeholders for regular updates.
Anforderungen
- Bachelor's Degree in scientific or healthcare discipline
- Higher Degree preferred
- Relevant clinical operations experience
- 4+ years progressive experience in clinical research
- Experience in biotech, pharma or CRO industry
- Proven clinical research experience
- Team lead experience in clinical functions
- CRA experience preferred
- Proficiency in Microsoft Word
- Proficiency in Microsoft Excel
- Proficiency in MS Project
- Proficiency in MS PowerPoint
- Proficiency in MS Outlook
- Travel as per business need
Aufgaben
- Deliver regional studies within agreed timelines and budget
- Lead regional clinical operations team and external partners
- Act as escalation point for regional study issues
- Align regional deliverables with overall study goals
- Collaborate with key stakeholders for regular updates
- Represent regional study team at internal and CST meetings
- Lead regional operations meetings with study team members
- Plan and manage assigned clinical studies from feasibility to closeout
- Generate and maintain high-quality study start-up and recruitment timelines
- Drive trial feasibility, country allocation, and site selection
- Provide regional input on global study plans
- Ensure timely availability of local study documents
- Submit study documents to regulatory authorities and ECs/IRBs
- Maintain regional and country information in study systems
- Collaborate with CRAs for proper study execution
- Review and sign-off monitoring reports
- Ensure Trial Master File creation and maintenance
- Provide input on drug inventories and local drug labels
- Manage trial data collection and query resolution
- Support planning and execution of Clinical Study Report
- Handle escalated issues with sites in collaboration with stakeholders
- Monitor study activities for compliance with protocols and regulations
- Ensure inspection readiness throughout study life cycle
- Inform Global Clinical Study Manager of issues and implement solutions
- Prepare sites for quality assurance audits and inspections
- Drive responses to audit and inspection findings
- Share cross-team and site learnings and best practices
- Lead improvements and enhance work quality
- Contribute to development and review of work instructions and SOPs
- Select and manage regional study vendors
- Manage regional study budgets
- Work with Clinical Business Operation on investigator fees and site payments
- Identify and manage regional team resource needs
- Establish contingency plans for key resources
- Monitor regional resource utilization over study life cycle
- Liaise with functional managers as needed
- Provide performance feedback on team members
- Mentor junior team members
- Use Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook efficiently
Berufserfahrung
- 4 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Microsoft Word
- Microsoft Excel
- MS Project
- MS PowerPoint
- MS Outlook
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne Medicines I GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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BEBeOne Medicines I GmbH
Regional Clinical Study Manager(m/w/x)
Basel
ab CHF 124.800 - 156.000 / Jahr
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Managing regional clinical operations for oncology studies, leading cross-functional teams and external partners. 4+ years progressive clinical research experience required. Collaboration with key stakeholders for regular updates.
Anforderungen
- Bachelor's Degree in scientific or healthcare discipline
- Higher Degree preferred
- Relevant clinical operations experience
- 4+ years progressive experience in clinical research
- Experience in biotech, pharma or CRO industry
- Proven clinical research experience
- Team lead experience in clinical functions
- CRA experience preferred
- Proficiency in Microsoft Word
- Proficiency in Microsoft Excel
- Proficiency in MS Project
- Proficiency in MS PowerPoint
- Proficiency in MS Outlook
- Travel as per business need
Aufgaben
- Deliver regional studies within agreed timelines and budget
- Lead regional clinical operations team and external partners
- Act as escalation point for regional study issues
- Align regional deliverables with overall study goals
- Collaborate with key stakeholders for regular updates
- Represent regional study team at internal and CST meetings
- Lead regional operations meetings with study team members
- Plan and manage assigned clinical studies from feasibility to closeout
- Generate and maintain high-quality study start-up and recruitment timelines
- Drive trial feasibility, country allocation, and site selection
- Provide regional input on global study plans
- Ensure timely availability of local study documents
- Submit study documents to regulatory authorities and ECs/IRBs
- Maintain regional and country information in study systems
- Collaborate with CRAs for proper study execution
- Review and sign-off monitoring reports
- Ensure Trial Master File creation and maintenance
- Provide input on drug inventories and local drug labels
- Manage trial data collection and query resolution
- Support planning and execution of Clinical Study Report
- Handle escalated issues with sites in collaboration with stakeholders
- Monitor study activities for compliance with protocols and regulations
- Ensure inspection readiness throughout study life cycle
- Inform Global Clinical Study Manager of issues and implement solutions
- Prepare sites for quality assurance audits and inspections
- Drive responses to audit and inspection findings
- Share cross-team and site learnings and best practices
- Lead improvements and enhance work quality
- Contribute to development and review of work instructions and SOPs
- Select and manage regional study vendors
- Manage regional study budgets
- Work with Clinical Business Operation on investigator fees and site payments
- Identify and manage regional team resource needs
- Establish contingency plans for key resources
- Monitor regional resource utilization over study life cycle
- Liaise with functional managers as needed
- Provide performance feedback on team members
- Mentor junior team members
- Use Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook efficiently
Berufserfahrung
- 4 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Microsoft Word
- Microsoft Excel
- MS Project
- MS PowerPoint
- MS Outlook
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne Medicines I GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
BeOne Medicines I GmbH
Branche
Pharmaceuticals
Beschreibung
The company is focused on fighting cancer and offers opportunities for scientific and business professionals.
Noch nicht perfekt?
- BeOne Medicines I GmbH
Associate Director, Regional Program Lead(m/w/x)
Vollzeitnur vor OrtManagementBasel - BeOne Medicines I GmbH
Regional Clinical Compliance Director/ Senior Director(m/w/x)
Vollzeitnur vor OrtManagementBasel - BeOne Medicines I GmbH
Senior Manager of Business & Strategic Operations, Global Clinical Operations Region EMEA(m/w/x)
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Clinical Research Associate(m/w/x)
Vollzeitnur vor OrtJuniorBaselab CHF 92.200 - 115.200 / Jahr - 1201 F. Hoffmann-La Roche AG
Global Clinical Operations Excellence Lead - Study Systems Lead(m/w/x)
Vollzeitnur vor OrtSeniorBasel