Roche Austria GmbH
Country Study Manager(m/w/x)
Full-timeOn-siteSenior
Wien
from 63,000 / year
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IQIQVIA
Local Study Associate Director(m/w/x)
Wien
from 58,500 / year
Full-timeOn-siteExperienced
Nejo AI Summary
Leading local study teams for clinical trials in oncology, rare diseases, cardiology, hematology, or CVRM. Minimum 3 years experience in Development Operations required. On-site work with rotating construction sites.
Requirements
- Bachelor degree in related discipline or equivalent qualification
- Minimum 3 years experience in Development Operations or related fields
- Good knowledge of ICH GCP and local regulations
- Ability to lead and motivate cross-functional teams
- Good medical knowledge of Oncology, Rare Diseases, cardiology, hematology, CVRM
- Good knowledge of Drug Development Process
- Excellent understanding of Clinical Study Process including monitoring
- Very good understanding of Study Drug Handling and Data Management
- Excellent project management skills
- Excellent ability to prioritize, handle multiple tasks, attention to details, negotiation skills
- Excellent spoken and written English and German
- Good ability to learn and adapt to IT systems
- Ability to travel nationally and internationally
Tasks
- Lead Local Study Teams to deliver clinical studies
- Manage study commitments within the country
- Ensure timely data delivery to required quality
- Lead and optimize Local Study Team performance
- Perform clinical and operational feasibility assessments
- Coordinate site selection and qualification
- Submit applications to EC/IRB and Regulatory Authority
- Prepare and maintain financial Study Management Agreement
- Prepare and update local Master CSA and site budget
- Prepare and manage Master Informed Consent Form
- Collect and verify trial essential documents
- Plan and coordinate local drug activities
- Set up and maintain study in CTMS and local websites
- Oversee and coordinate monitoring activities
- Review monitoring visit reports
- Perform co-monitoring and training visits
- Identify and resolve complex study issues
- Organize Local Study Team meetings
- Build relationships with team members and stakeholders
- Report study progress to Global Study Team
- Contribute to patient recruitment strategy
- Develop and review risk management plan
- Communicate with National Co-ordinating Investigator
- Plan and lead National Investigator meetings
- Prepare study documents for final archiving
- Plan and lead audit and inspection activities
- Provide input to process development
- Inform Line Managers of study milestones
- Update Line Managers on CRA/CSA performance
- Ensure compliance with local policies and ethics
- Provide feedback on research information
- Collaborate with local Medical Affairs team
- Support SMM in various initiatives
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of IQVIA 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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IQIQVIA
Local Study Associate Director(m/w/x)
Wien
from 58,500 / year
Full-timeOn-siteExperienced
Nejo AI Summary
Leading local study teams for clinical trials in oncology, rare diseases, cardiology, hematology, or CVRM. Minimum 3 years experience in Development Operations required. On-site work with rotating construction sites.
Requirements
- Bachelor degree in related discipline or equivalent qualification
- Minimum 3 years experience in Development Operations or related fields
- Good knowledge of ICH GCP and local regulations
- Ability to lead and motivate cross-functional teams
- Good medical knowledge of Oncology, Rare Diseases, cardiology, hematology, CVRM
- Good knowledge of Drug Development Process
- Excellent understanding of Clinical Study Process including monitoring
- Very good understanding of Study Drug Handling and Data Management
- Excellent project management skills
- Excellent ability to prioritize, handle multiple tasks, attention to details, negotiation skills
- Excellent spoken and written English and German
- Good ability to learn and adapt to IT systems
- Ability to travel nationally and internationally
Tasks
- Lead Local Study Teams to deliver clinical studies
- Manage study commitments within the country
- Ensure timely data delivery to required quality
- Lead and optimize Local Study Team performance
- Perform clinical and operational feasibility assessments
- Coordinate site selection and qualification
- Submit applications to EC/IRB and Regulatory Authority
- Prepare and maintain financial Study Management Agreement
- Prepare and update local Master CSA and site budget
- Prepare and manage Master Informed Consent Form
- Collect and verify trial essential documents
- Plan and coordinate local drug activities
- Set up and maintain study in CTMS and local websites
- Oversee and coordinate monitoring activities
- Review monitoring visit reports
- Perform co-monitoring and training visits
- Identify and resolve complex study issues
- Organize Local Study Team meetings
- Build relationships with team members and stakeholders
- Report study progress to Global Study Team
- Contribute to patient recruitment strategy
- Develop and review risk management plan
- Communicate with National Co-ordinating Investigator
- Plan and lead National Investigator meetings
- Prepare study documents for final archiving
- Plan and lead audit and inspection activities
- Provide input to process development
- Inform Line Managers of study milestones
- Update Line Managers on CRA/CSA performance
- Ensure compliance with local policies and ethics
- Provide feedback on research information
- Collaborate with local Medical Affairs team
- Support SMM in various initiatives
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of IQVIA 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
IQVIA
Industry
Healthcare
Description
IQVIA is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.
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