BeOne Medicines I GmbH
Associate Director, Regional Program Lead(m/w/x)
Full-timeOn-siteManagement
Basel
New Job?Nejo!
Your personal AI career agent
BEBeOne Medicines I GmbH
Regional Clinical Study Manager(m/w/x)
Basel
from CHF 124,800 - 156,000 / year
Full-timeOn-siteExperienced
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 4 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Microsoft Word
- Microsoft Excel
- MS Project
- MS PowerPoint
- MS Outlook
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines I GmbH 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.
Not a perfect match?
- BeOne Medicines I GmbH
Regional Clinical Compliance Director/ Senior Director(m/w/x)
Full-timeOn-siteManagementBasel - BeOne Medicines I GmbH
Senior Manager of Business & Strategic Operations, Global Clinical Operations Region EMEA(m/w/x)
Full-timeOn-siteSeniorBasel - BeOne Medicines I GmbH
Clinical Research Associate(m/w/x)
Full-timeOn-siteJuniorBaselfrom CHF 92,200 - 115,200 / year - 1201 F. Hoffmann-La Roche AG
Global Clinical Operations Excellence Lead - Study Systems Lead(m/w/x)
Full-timeOn-siteSeniorBasel
BEBeOne Medicines I GmbH
Regional Clinical Study Manager(m/w/x)
Basel
from CHF 124,800 - 156,000 / year
Full-timeOn-siteExperienced
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 4 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Microsoft Word
- Microsoft Excel
- MS Project
- MS PowerPoint
- MS Outlook
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines I GmbH 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
BeOne Medicines I GmbH
Industry
Pharmaceuticals
Description
The company is focused on fighting cancer and offers opportunities for scientific and business professionals.
Not a perfect match?
- BeOne Medicines I GmbH
Associate Director, Regional Program Lead(m/w/x)
Full-timeOn-siteManagementBasel - BeOne Medicines I GmbH
Regional Clinical Compliance Director/ Senior Director(m/w/x)
Full-timeOn-siteManagementBasel - BeOne Medicines I GmbH
Senior Manager of Business & Strategic Operations, Global Clinical Operations Region EMEA(m/w/x)
Full-timeOn-siteSeniorBasel - BeOne Medicines I GmbH
Clinical Research Associate(m/w/x)
Full-timeOn-siteJuniorBaselfrom CHF 92,200 - 115,200 / year - 1201 F. Hoffmann-La Roche AG
Global Clinical Operations Excellence Lead - Study Systems Lead(m/w/x)
Full-timeOn-siteSeniorBasel