PSI CRO
Central Monitoring Manager(m/w/x)
Vollzeitmit HomeofficeBerufserfahren
München
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
ALAlira Health GmbH
Vice President, Monitoring and Site Engagement(m/w/x)
München
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Overseeing Directors of Clinical Monitoring across Europe and North America for a clinical leadership organization. 15 years of industry experience and 8 years of management experience required. Normal office working conditions, occasional lifting up to 30 lbs.
Anforderungen
- 15 years pharmaceutical/biotechnology/CRO industry experience
- 8 years management experience
- Monitoring all clinical trial phases
- Previous sponsor/pharmaceutical company experience
- Client oversight/management experience
- Proven leadership skills
- Strong organizational management skills
- Excellent written and verbal communication skills
- Strong interpersonal skills in fast-paced environment
- Strong interpersonal skills in deadline-oriented environment
- Strong interpersonal skills in changing environment
- Excellent multi-tasking ability
- Excellent administrative detail handling
- Ability to handle tasks in fast-paced environment
- Ability to handle tasks in constantly changing environment
- Sound judgment and independent decision-making
- Excellent self-motivation skills
- Thorough understanding of drug development process
- Thorough understanding of regulatory aspects of clinical development
- Thorough understanding of ICH Good Clinical Practices
- Strong interpersonal skills
- Ability to function in a team environment
- Proficient with MS Office Suite
- Proficient with MS Word
- Proficient with MS Excel
- Bachelor of Science (BS)
Aufgaben
- Oversee Directors of Clinical Monitoring in Europe and North America
- Ensure operational excellence in monitoring activities
- Deliver high-quality outcomes to sponsors
- Meet expectations, timelines, and regulatory standards
- Establish and lead a new organizational unit for feasibility assessments
- Develop and manage a robust network of site partnerships
- Oversee site contracting processes
- Provide strategic and operational leadership to the study start-up group
- Interview, hire, train, and evaluate performance of team members
- Mentor and ensure compliance across assigned teams and activities
- Serve as a leader and point of escalation for Directors of Clinical Monitoring and Study Start-Up
- Develop and maintain a network of clinical study sites
- Facilitate partnerships with institutions for collaboration
- Collaborate with sponsors and Alira Health teams for issue resolution
- Identify and mitigate risks to quality and compliance
- Develop and improve Standard Operating Procedures
- Participate in sponsor and regulatory authority audits
- Monitor clinical team performance indicators and metrics
- Conduct regular resource and workload assessments
- Support professional development and annual reviews of direct reports
- Interview and select potential employees
- Oversee and assess CRAs with the Lead CRA
- Lead corrective action plans for CRAs
- Contribute to proposals and budgets for new projects
- Participate in BID Defense meetings and client presentations
- Assess project budgets, risks, and scope
- Ensure proper project delivery
- Set client expectations for project delivery
- Manage external vendors to ensure contract compliance
- Comply with ICH GCP guidelines, ISO14155, and company SOPs
Berufserfahrung
- 15 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office Suite
- MS Word
- MS Excel
Benefits
Sonstige Vorteile
- Normal office working conditions
- Occasional lifting up to 30 lbs
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Alira Health GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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ALAlira Health GmbH
Vice President, Monitoring and Site Engagement(m/w/x)
München
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Overseeing Directors of Clinical Monitoring across Europe and North America for a clinical leadership organization. 15 years of industry experience and 8 years of management experience required. Normal office working conditions, occasional lifting up to 30 lbs.
Anforderungen
- 15 years pharmaceutical/biotechnology/CRO industry experience
- 8 years management experience
- Monitoring all clinical trial phases
- Previous sponsor/pharmaceutical company experience
- Client oversight/management experience
- Proven leadership skills
- Strong organizational management skills
- Excellent written and verbal communication skills
- Strong interpersonal skills in fast-paced environment
- Strong interpersonal skills in deadline-oriented environment
- Strong interpersonal skills in changing environment
- Excellent multi-tasking ability
- Excellent administrative detail handling
- Ability to handle tasks in fast-paced environment
- Ability to handle tasks in constantly changing environment
- Sound judgment and independent decision-making
- Excellent self-motivation skills
- Thorough understanding of drug development process
- Thorough understanding of regulatory aspects of clinical development
- Thorough understanding of ICH Good Clinical Practices
- Strong interpersonal skills
- Ability to function in a team environment
- Proficient with MS Office Suite
- Proficient with MS Word
- Proficient with MS Excel
- Bachelor of Science (BS)
Aufgaben
- Oversee Directors of Clinical Monitoring in Europe and North America
- Ensure operational excellence in monitoring activities
- Deliver high-quality outcomes to sponsors
- Meet expectations, timelines, and regulatory standards
- Establish and lead a new organizational unit for feasibility assessments
- Develop and manage a robust network of site partnerships
- Oversee site contracting processes
- Provide strategic and operational leadership to the study start-up group
- Interview, hire, train, and evaluate performance of team members
- Mentor and ensure compliance across assigned teams and activities
- Serve as a leader and point of escalation for Directors of Clinical Monitoring and Study Start-Up
- Develop and maintain a network of clinical study sites
- Facilitate partnerships with institutions for collaboration
- Collaborate with sponsors and Alira Health teams for issue resolution
- Identify and mitigate risks to quality and compliance
- Develop and improve Standard Operating Procedures
- Participate in sponsor and regulatory authority audits
- Monitor clinical team performance indicators and metrics
- Conduct regular resource and workload assessments
- Support professional development and annual reviews of direct reports
- Interview and select potential employees
- Oversee and assess CRAs with the Lead CRA
- Lead corrective action plans for CRAs
- Contribute to proposals and budgets for new projects
- Participate in BID Defense meetings and client presentations
- Assess project budgets, risks, and scope
- Ensure proper project delivery
- Set client expectations for project delivery
- Manage external vendors to ensure contract compliance
- Comply with ICH GCP guidelines, ISO14155, and company SOPs
Berufserfahrung
- 15 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office Suite
- MS Word
- MS Excel
Benefits
Sonstige Vorteile
- Normal office working conditions
- Occasional lifting up to 30 lbs
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Alira Health GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Alira Health GmbH
Branche
Healthcare
Beschreibung
Alira Health is a clinical leadership organization focused on operational excellence in monitoring, site engagement, and study start-up.
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