Dein persönlicher KI-Karriere-Agent
Study Start Up Specialist(m/w/x)
Submitting clinical trial applications and ethics committee documentation for a global CRO. 2+ years clinical research experience required. 4 weeks vacation, health insurance.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 2 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Mehr Urlaubstage
- Various annual leave entitlements
Gesundheits- & Fitnessangebote
- Health insurance offerings
- Health assessments
Betriebliche Altersvorsorge
- Retirement planning offerings
Mentale Gesundheitsförderung
- Global Employee Assistance Programme
Sonstige Vorteile
- Life assurance
Sonstige Zulagen
- Childcare vouchers
Firmenfahrrad
- Bike purchase schemes
Mitarbeiterrabatte
- Discounted gym memberships
Öffi Tickets
- Subsidised travel passes
Noch nicht perfekt?
- 176 ICON Clinical Research Germany GmbHVollzeitRemoteBerufserfahrenFrankfurt am Main
- ICON plc
Study Start Up Associate I(m/w/x)
VollzeitRemoteBerufserfahrenFrankfurt am Main - ICON plc
(Senior) Clinical Trial Assistant(m/w/x)
VollzeitRemoteBerufserfahrenFrankfurt am Main - IQVIA
Study Site Management Specialist(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenFrankfurt am Main - ICON plc
Clinical Research Associate - Sponsor Dedicated(m/w/x)
VollzeitRemoteBerufserfahrenFrankfurt am Main
Study Start Up Specialist(m/w/x)
Submitting clinical trial applications and ethics committee documentation for a global CRO. 2+ years clinical research experience required. 4 weeks vacation, health insurance.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 2 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Mehr Urlaubstage
- Various annual leave entitlements
Gesundheits- & Fitnessangebote
- Health insurance offerings
- Health assessments
Betriebliche Altersvorsorge
- Retirement planning offerings
Mentale Gesundheitsförderung
- Global Employee Assistance Programme
Sonstige Vorteile
- Life assurance
Sonstige Zulagen
- Childcare vouchers
Firmenfahrrad
- Bike purchase schemes
Mitarbeiterrabatte
- Discounted gym memberships
Öffi Tickets
- Subsidised travel passes
Über das Unternehmen
ICON plc
Branche
Healthcare
Beschreibung
ICON plc is a world-leading healthcare intelligence and clinical research organization.
Noch nicht perfekt?
- 176 ICON Clinical Research Germany GmbH
Study Start Up Associate II(m/w/x)
VollzeitRemoteBerufserfahrenFrankfurt am Main - ICON plc
Study Start Up Associate I(m/w/x)
VollzeitRemoteBerufserfahrenFrankfurt am Main - ICON plc
(Senior) Clinical Trial Assistant(m/w/x)
VollzeitRemoteBerufserfahrenFrankfurt am Main - IQVIA
Study Site Management Specialist(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenFrankfurt am Main - ICON plc
Clinical Research Associate - Sponsor Dedicated(m/w/x)
VollzeitRemoteBerufserfahrenFrankfurt am Main