IQVIA
Associate Clinical Project Manager(m/w/x)
Full-timeOn-siteExperienced
Frankfurt am Main
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IQIQVIA
Local Study Associate Director - Sponsor Dedicated(m/w/x)
Frankfurt am Main
Full-timeOn-siteExperienced
Nejo AI Summary
Leading local clinical study teams for IQVIA, ensuring compliance with ICH-GCP and local regulations. Minimum 3 years in Development Operations required. Site monitoring and documentation archiving.
Requirements
- Bachelor degree in life science or equivalent qualification
- Minimum 3 years of experience in Development Operations (CRA, SrCRA) or related fields
- Good knowledge of ICH GCP and local regulations
- Ability to lead and motivate cross functional teams
- Good medical knowledge and ability to learn therapeutic areas
- Good knowledge of Drug Development Process
- Excellent understanding of Clinical Study Process including monitoring
- Very good understanding of Study Drug Handling Process
- Very good understanding of Data Management Process
- Excellent project management skills
- Excellent team building and interpersonal skills
- Excellent organizational skill
- Excellent verbal and written communication skills
- Excellent ability to prioritize and handle multiple tasks
- Excellent attention to details
- Excellent negotiation skills
- Excellent knowledge of spoken and written English
- Excellent knowledge of local languages
- Good ability to learn and adapt to IT systems
- Ability to travel nationally and internationally
Tasks
- Lead Local Study Teams to deliver clinical studies on time and within budget
- Ensure compliance with procedural documents, ICH-GCP, and local regulations
- Perform site monitoring as needed to support flexible capacity
- Ensure sites are identified, qualified, set up, initiated, monitored, and closed
- Archive study documentation
- Take overall responsibility for study commitments and data quality within the country
- Lead and optimize Local Study Team performance
- Ensure high-quality clinical and operational feasibility assessments
- Coordinate site selection, including identifying potential sites and investigators
- Perform initial Site Quality Risk Assessments
- Conduct Site Qualification Visits
- Ensure timely submission of documents to EC/IRB and Regulatory Authority
- Prepare country financial Study Management Agreements
- Maintain accurate study budgets in the financial system
- Prepare local Master CSA and amendments
- Prepare country level Master Informed Consent Form and site level ICFs
- Ensure collection and verification of essential trial documents
- Plan and coordinate local drug activities
- Set up and maintain the study in CTMS at country level
- Maintain local websites as required by law
- Oversee, manage, and coordinate monitoring activities
- Review monitoring visit reports and advise monitors
- Perform co-monitoring and Accompanied Site Visits
- Proactively identify and resolve study risks and issues
- Organize regular Local Study Team meetings
- Build strong relationships with team members, site staff, and stakeholders
- Report study progress to Global Study Associate Director and Global Study Team
- Contribute to patient recruitment strategy and communicate with investigators
- Develop, maintain, and review risk management plans
- Manage sites, stakeholders, vendors, and customers to mitigate risks
- Communicate and coordinate with National Co-ordinating Investigator/National Lead Investigator
- Plan and lead National Investigator meetings
- Ensure all study documents are ready for final archiving
- Complete the local part of the eTMF
- Plan and lead activities for audits and regulatory inspections
- Provide input to process development and improvement
- Provide regular study updates to Line Managers
- Update Line Managers on CRA/CSA performance
- Ensure study activities comply with local policies and code of ethics
- Provide feedback on research-related information for the local market
- Ensure compliance with Sponsor's Code of Ethics and company policies
- Collaborate with local Medical Affairs team
- Support SMM in various initiatives
Work Experience
- 3 years
Education
- Compulsory education
Languages
- English – Business Fluent
- local – 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 - Sponsor Dedicated(m/w/x)
Frankfurt am Main
Full-timeOn-siteExperienced
Nejo AI Summary
Leading local clinical study teams for IQVIA, ensuring compliance with ICH-GCP and local regulations. Minimum 3 years in Development Operations required. Site monitoring and documentation archiving.
Requirements
- Bachelor degree in life science or equivalent qualification
- Minimum 3 years of experience in Development Operations (CRA, SrCRA) or related fields
- Good knowledge of ICH GCP and local regulations
- Ability to lead and motivate cross functional teams
- Good medical knowledge and ability to learn therapeutic areas
- Good knowledge of Drug Development Process
- Excellent understanding of Clinical Study Process including monitoring
- Very good understanding of Study Drug Handling Process
- Very good understanding of Data Management Process
- Excellent project management skills
- Excellent team building and interpersonal skills
- Excellent organizational skill
- Excellent verbal and written communication skills
- Excellent ability to prioritize and handle multiple tasks
- Excellent attention to details
- Excellent negotiation skills
- Excellent knowledge of spoken and written English
- Excellent knowledge of local languages
- Good ability to learn and adapt to IT systems
- Ability to travel nationally and internationally
Tasks
- Lead Local Study Teams to deliver clinical studies on time and within budget
- Ensure compliance with procedural documents, ICH-GCP, and local regulations
- Perform site monitoring as needed to support flexible capacity
- Ensure sites are identified, qualified, set up, initiated, monitored, and closed
- Archive study documentation
- Take overall responsibility for study commitments and data quality within the country
- Lead and optimize Local Study Team performance
- Ensure high-quality clinical and operational feasibility assessments
- Coordinate site selection, including identifying potential sites and investigators
- Perform initial Site Quality Risk Assessments
- Conduct Site Qualification Visits
- Ensure timely submission of documents to EC/IRB and Regulatory Authority
- Prepare country financial Study Management Agreements
- Maintain accurate study budgets in the financial system
- Prepare local Master CSA and amendments
- Prepare country level Master Informed Consent Form and site level ICFs
- Ensure collection and verification of essential trial documents
- Plan and coordinate local drug activities
- Set up and maintain the study in CTMS at country level
- Maintain local websites as required by law
- Oversee, manage, and coordinate monitoring activities
- Review monitoring visit reports and advise monitors
- Perform co-monitoring and Accompanied Site Visits
- Proactively identify and resolve study risks and issues
- Organize regular Local Study Team meetings
- Build strong relationships with team members, site staff, and stakeholders
- Report study progress to Global Study Associate Director and Global Study Team
- Contribute to patient recruitment strategy and communicate with investigators
- Develop, maintain, and review risk management plans
- Manage sites, stakeholders, vendors, and customers to mitigate risks
- Communicate and coordinate with National Co-ordinating Investigator/National Lead Investigator
- Plan and lead National Investigator meetings
- Ensure all study documents are ready for final archiving
- Complete the local part of the eTMF
- Plan and lead activities for audits and regulatory inspections
- Provide input to process development and improvement
- Provide regular study updates to Line Managers
- Update Line Managers on CRA/CSA performance
- Ensure study activities comply with local policies and code of ethics
- Provide feedback on research-related information for the local market
- Ensure compliance with Sponsor's Code of Ethics and company policies
- Collaborate with local Medical Affairs team
- Support SMM in various initiatives
Work Experience
- 3 years
Education
- Compulsory education
Languages
- English – Business Fluent
- local – 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.
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.
Not a perfect match?
- IQVIA
Associate Clinical Project Manager(m/w/x)
Full-timeOn-siteExperiencedFrankfurt am Main - IQVIA
Associate Medical Director- Oncology ,Sponsor-Dedicated(m/w/x)
Full-timeOn-siteSeniorFrankfurt am Main - IQVIA RDS GmbH
Clinical Trial Educator I(m/w/x)
Full-timeOn-siteJuniorFrankfurt am Main - Fresenius Kabi Deutschland GmbH
Senior Manager Clinical Operations(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhe - Sanofi-Aventis Deutschland GmbH
PV Literature Surveillance Expert(m/w/x)
Full-timeOn-siteExperiencedFrankfurt am Main