176 ICON Clinical Research Germany GmbH
Study Start Up Associate II(m/w/x)
Full-timeRemoteExperienced
Frankfurt am Main
New Job?Nejo!
Your personal AI career agent
ICICON plc
Study Start Up Specialist(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Submitting clinical trial applications and ethics committee documentation for a global CRO. 2+ years clinical research experience required. 4 weeks vacation, health insurance.
Requirements
- Relevant site start-up and activation experience
- Bachelor's degree in life sciences or related field
- Minimum 2 years clinical research or regulatory affairs experience
- Specific experience in study start-up activities
- Strong understanding of regulatory requirements and guidelines for clinical trials
- Knowledge of ICH-GCP and local regulatory requirements
- Excellent organizational and project management skills
- Ability to prioritize and manage multiple tasks
- Excellent communication and interpersonal skills
- Ability to collaborate effectively with cross-functional teams
- Willingness to travel as required
- Encouraged to apply even if not meeting all requirements
Tasks
- Lead preparation and submission of regulatory documents
- Submit clinical trial applications
- Handle ethics committee submissions
- Communicate with regulatory agencies
- Coordinate with internal and external stakeholders
- Obtain necessary approvals and authorizations
- Maintain records of regulatory submissions and approvals
- Keep comprehensive and accurate correspondence records
- Guide study teams on regulatory requirements
- Support study teams with best practices
- Participate in process improvement initiatives
- Streamline study start-up processes
- Enhance efficiency of study start-up activities
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
More Vacation Days
- Various annual leave entitlements
Healthcare & Fitness
- Health insurance offerings
- Health assessments
Retirement Plans
- Retirement planning offerings
Mental Health Support
- Global Employee Assistance Programme
Other Benefits
- Life assurance
Additional Allowances
- Childcare vouchers
Company Bike
- Bike purchase schemes
Corporate Discounts
- Discounted gym memberships
Public Transport Subsidies
- Subsidised travel passes
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ICON plc 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
Study Start Up Associate I(m/w/x)
Full-timeRemoteExperiencedFrankfurt am Main - ICON plc
(Senior) Clinical Trial Assistant(m/w/x)
Full-timeRemoteExperiencedFrankfurt am Main - IQVIA
Study Site Management Specialist(m/w/x)
Full-timeWith HomeofficeExperiencedFrankfurt am Main - ICON plc
Clinical Research Associate - Sponsor Dedicated(m/w/x)
Full-timeRemoteExperiencedFrankfurt am Main
ICICON plc
Study Start Up Specialist(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Submitting clinical trial applications and ethics committee documentation for a global CRO. 2+ years clinical research experience required. 4 weeks vacation, health insurance.
Requirements
- Relevant site start-up and activation experience
- Bachelor's degree in life sciences or related field
- Minimum 2 years clinical research or regulatory affairs experience
- Specific experience in study start-up activities
- Strong understanding of regulatory requirements and guidelines for clinical trials
- Knowledge of ICH-GCP and local regulatory requirements
- Excellent organizational and project management skills
- Ability to prioritize and manage multiple tasks
- Excellent communication and interpersonal skills
- Ability to collaborate effectively with cross-functional teams
- Willingness to travel as required
- Encouraged to apply even if not meeting all requirements
Tasks
- Lead preparation and submission of regulatory documents
- Submit clinical trial applications
- Handle ethics committee submissions
- Communicate with regulatory agencies
- Coordinate with internal and external stakeholders
- Obtain necessary approvals and authorizations
- Maintain records of regulatory submissions and approvals
- Keep comprehensive and accurate correspondence records
- Guide study teams on regulatory requirements
- Support study teams with best practices
- Participate in process improvement initiatives
- Streamline study start-up processes
- Enhance efficiency of study start-up activities
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
More Vacation Days
- Various annual leave entitlements
Healthcare & Fitness
- Health insurance offerings
- Health assessments
Retirement Plans
- Retirement planning offerings
Mental Health Support
- Global Employee Assistance Programme
Other Benefits
- Life assurance
Additional Allowances
- Childcare vouchers
Company Bike
- Bike purchase schemes
Corporate Discounts
- Discounted gym memberships
Public Transport Subsidies
- Subsidised travel passes
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ICON plc 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
ICON plc
Industry
Healthcare
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization.
Not a perfect match?
- 176 ICON Clinical Research Germany GmbH
Study Start Up Associate II(m/w/x)
Full-timeRemoteExperiencedFrankfurt am Main - ICON plc
Study Start Up Associate I(m/w/x)
Full-timeRemoteExperiencedFrankfurt am Main - ICON plc
(Senior) Clinical Trial Assistant(m/w/x)
Full-timeRemoteExperiencedFrankfurt am Main - IQVIA
Study Site Management Specialist(m/w/x)
Full-timeWith HomeofficeExperiencedFrankfurt am Main - ICON plc
Clinical Research Associate - Sponsor Dedicated(m/w/x)
Full-timeRemoteExperiencedFrankfurt am Main