IQVIA
Study Site Management Specialist(m/w/x)
Full-timeWith HomeofficeExperienced
Frankfurt am Main
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IQIQVIA Biotech
Clinical Associate Submissions – Regulatory(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeJunior
Nejo AI Summary
Country-level site activation for clinical trials, adhering to EU CTR regulations. EU CTR experience for Germany and Austria required. Local language proficiency and address for submissions.
Requirements
- EU CTR experience for Germany and Austria
- Local language proficiency
- Knowledge of national requirements
- Local address for submission tasks
- B Sc degree in Health Sciences or related field
- 1-3 years relevant clinical research experience
- Experience in submissions
- Experience in EUCTR and CTIS submission procedures
- Feasibility experience for DACH regions
- Country Inform Consent adaptation for DACH regions
- Experience in Site Contract negotiations with DACH sites
- Experience in medical device submissions
- In-depth knowledge of clinical systems
- In-depth knowledge of clinical procedures
- In-depth knowledge of corporate standards
- Good negotiating skills in local language
- Good communication skills in local language
- Effective communication skills
- Organizational skills
- Interpersonal skills
- Ability to work independently
- Ability to effectively prioritize tasks
- Ability to manage multiple projects
- Knowledge of GCP/ICH
- Ability to apply GCP/ICH
- Knowledge of applicable regulatory guidelines
- Ability to apply applicable regulatory guidelines
- Understanding of regulated clinical trial environment
- Knowledge of drug development process
Tasks
- Perform country-level Site Activation activities
- Adhere to local/international regulations and SOPs
- Manage project requirements and budgetary guidelines
- Perform maintenance activities
- Lead complex projects under general supervision
- Serve as Single Point of Contact for investigative sites
- Liaise with Site Activation Manager and Project Management team
- Collaborate with other departments as needed
- Ensure adherence to Work Instructions
- Maintain quality of designated deliverables
- Meet project timelines
- Prepare submission documents for regulatory bodies
- Submit documents to regulatory bodies
- Perform feasibility studies
- Conduct site identification
- Manage start-up activities
- Distribute completed documents to sites
- Distribute completed documents to internal project teams
- Prepare site documents
- Review site documents for completeness
- Review site documents for accuracy
- Track document progress
- Follow up on document approval
- Follow up on document execution
- Manage CDA/SIF document progress
- Manage regulatory document progress
- Manage ethics document progress
- Manage Informed Consent Form progress
- Manage Investigator Pack release documents
- Inform team members of document completion
- Provide local expertise to SAMs
- Provide local expertise to project teams
- Perform quality control of site-provided documents
- Act as an SME on specific subjects
- Mentor junior CSAs
- Engage in sponsor-facing roles
Work Experience
- 1 - 3 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- EU CTR
- CTIS
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of IQVIA Biotech 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.
Not a perfect match?
- ICON plc
Clinical Site Associate(m/w/x)
Full-timeWith HomeofficeJuniorFrankfurt am Main - IQVIA
Clinical Research Associate 1 or 2, Single Sponsor(m/w/x)
Full-timeRemoteJuniorFrankfurt am Main - IQVIA
Clinical Research Associate 2 or Senior Clinical Research Associate 1(m/w/x)
Full-timeWith HomeofficeSeniorFrankfurt am Main - 176 ICON Clinical Research Germany GmbH
CRA II/ Senior CRA(m/w/x)
Full-timeWith HomeofficeSeniorFrankfurt am Main
IQIQVIA Biotech
Clinical Associate Submissions – Regulatory(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeJunior
Nejo AI Summary
Country-level site activation for clinical trials, adhering to EU CTR regulations. EU CTR experience for Germany and Austria required. Local language proficiency and address for submissions.
Requirements
- EU CTR experience for Germany and Austria
- Local language proficiency
- Knowledge of national requirements
- Local address for submission tasks
- B Sc degree in Health Sciences or related field
- 1-3 years relevant clinical research experience
- Experience in submissions
- Experience in EUCTR and CTIS submission procedures
- Feasibility experience for DACH regions
- Country Inform Consent adaptation for DACH regions
- Experience in Site Contract negotiations with DACH sites
- Experience in medical device submissions
- In-depth knowledge of clinical systems
- In-depth knowledge of clinical procedures
- In-depth knowledge of corporate standards
- Good negotiating skills in local language
- Good communication skills in local language
- Effective communication skills
- Organizational skills
- Interpersonal skills
- Ability to work independently
- Ability to effectively prioritize tasks
- Ability to manage multiple projects
- Knowledge of GCP/ICH
- Ability to apply GCP/ICH
- Knowledge of applicable regulatory guidelines
- Ability to apply applicable regulatory guidelines
- Understanding of regulated clinical trial environment
- Knowledge of drug development process
Tasks
- Perform country-level Site Activation activities
- Adhere to local/international regulations and SOPs
- Manage project requirements and budgetary guidelines
- Perform maintenance activities
- Lead complex projects under general supervision
- Serve as Single Point of Contact for investigative sites
- Liaise with Site Activation Manager and Project Management team
- Collaborate with other departments as needed
- Ensure adherence to Work Instructions
- Maintain quality of designated deliverables
- Meet project timelines
- Prepare submission documents for regulatory bodies
- Submit documents to regulatory bodies
- Perform feasibility studies
- Conduct site identification
- Manage start-up activities
- Distribute completed documents to sites
- Distribute completed documents to internal project teams
- Prepare site documents
- Review site documents for completeness
- Review site documents for accuracy
- Track document progress
- Follow up on document approval
- Follow up on document execution
- Manage CDA/SIF document progress
- Manage regulatory document progress
- Manage ethics document progress
- Manage Informed Consent Form progress
- Manage Investigator Pack release documents
- Inform team members of document completion
- Provide local expertise to SAMs
- Provide local expertise to project teams
- Perform quality control of site-provided documents
- Act as an SME on specific subjects
- Mentor junior CSAs
- Engage in sponsor-facing roles
Work Experience
- 1 - 3 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- EU CTR
- CTIS
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of IQVIA Biotech 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 Biotech
Industry
Pharmaceuticals
Description
The company partners with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas.
Not a perfect match?
- IQVIA
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Full-timeWith HomeofficeExperiencedFrankfurt am Main - ICON plc
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Clinical Research Associate 1 or 2, Single Sponsor(m/w/x)
Full-timeRemoteJuniorFrankfurt am Main - IQVIA
Clinical Research Associate 2 or Senior Clinical Research Associate 1(m/w/x)
Full-timeWith HomeofficeSeniorFrankfurt am Main - 176 ICON Clinical Research Germany GmbH
CRA II/ Senior CRA(m/w/x)
Full-timeWith HomeofficeSeniorFrankfurt am Main