Alexion
Clinical Research Associate(m/w/x)
Vollzeitnur vor OrtManagement
München
Neuer Job?Nejo!
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BPBP13 Alexion Pharma Germany Company
Country Study Manager(m/w/x)
München
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Managing clinical trial compliance with GCP and regulatory requirements for a global biopharma company. Oversight and delivery of clinical trial process stages required. Collaboration with regulatory authorities and ethics committees.
Anforderungen
- Oversight and delivery of clinical trial process stages
- Solid knowledge of clinical development processes
- Leadership, troubleshooting, and influencing skills
- Excellent knowledge of ICH-GCP guidelines
- Basic knowledge of GMP/GDP
- Effective communication with site staff and KOLs
- Comprehensive and current regulatory knowledge
- GCP knowledge
- Experience conducting GCP training
- Experience conducting other training
- Flexibility in schedule
- Willingness to travel
- Good organizational skills
- Ability to deal with competing priorities
- Effective written communication skills
- Effective verbal communication skills
- Effective presentation skills
- Creative thinking
- Curiosity
- Unafraid to ask questions
- Initiating changes
- Introducing new ideas
- Creative problem solving
- Proficiency with MS Office Suite
- Valid driving license
- Ability to work with remote collaborators
- Ability to work in a matrix reporting structure
- Positive approach to managing change
- Seeing change as opportunity for improvement
- Ability to prioritize tasks
- Ability to manage multiple tasks with conflicting deadlines
- Team oriented
- Flexibility to respond to shifting demands
- Flexibility to respond to shifting opportunities
- Bachelor's Degree or equivalent in clinical practice/health care, life sciences or drug development
- Clinical or advanced degree preferred
- 3+ years of relevant experience gained with a CRO or pharmaceutical company
- Experience working on clinical studies
- Lead CRA experience preferred
- Senior CRA experience preferred
- Management experience preferred
Aufgaben
- Ensure study compliance with GCP and regulatory requirements
- Collaborate with SSU manager, CSA, and CRAs to meet study commitments
- Interact with Regulatory Authorities and Ethics Committees
- Support submission and approval processes for projects
- Ensure site activation requirements are met
- Work with Head of Country Operations and AD COM for study resourcing
- Act as local study manager and monitor
- Perform site monitoring activities and oversight
- Deliver quality and timely study deliverables
- Report study-specific issues to global and country teams
- Ensure quality of monitoring oversight
- Meet recruitment targets for studies
- Negotiate and deliver CDAs based on pre-approved parameters
- Customize ICFs at country/site level
- Negotiate site study contracts and budgets
- Review local regulatory documentation
- Manage relationships with national coordinating investigators
- Coordinate country-level engagement activities
- Lead recruitment discussions locally
- Respond to study team queries
- Conduct site feasibility assessments
- Submit and resolve EC/CA queries
- Coordinate study-specific training of CRAs
- Oversee dedicated or FSP CRAs
- Review clinical monitoring documentation
- Coordinate inspection readiness activities
- Identify and manage risks to study quality
- Perform selection, initiation, interim, and closeout visits
- Conduct remote data checks
- Drive site performance
- Resolve study-related issues proactively
- Escalate issues as appropriate
- Train and support investigators and site staff
- Develop and manage recruitment plans
- Document recruitment barriers and mitigation plans
- Ensure monitoring KPIs are within acceptable ranges
- Prepare and finalize monitoring visit reports
- Collect and upload essential documents into eTMF
- Support regular QC checks of eTMF
- Collaborate with local Medical Affairs and other stakeholders
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office Suite
- Excel
- Word
- PowerPoint
- ICH-GCP
- GMP
- GDP
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BP13 Alexion Pharma Germany Company 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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BPBP13 Alexion Pharma Germany Company
Country Study Manager(m/w/x)
München
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Managing clinical trial compliance with GCP and regulatory requirements for a global biopharma company. Oversight and delivery of clinical trial process stages required. Collaboration with regulatory authorities and ethics committees.
Anforderungen
- Oversight and delivery of clinical trial process stages
- Solid knowledge of clinical development processes
- Leadership, troubleshooting, and influencing skills
- Excellent knowledge of ICH-GCP guidelines
- Basic knowledge of GMP/GDP
- Effective communication with site staff and KOLs
- Comprehensive and current regulatory knowledge
- GCP knowledge
- Experience conducting GCP training
- Experience conducting other training
- Flexibility in schedule
- Willingness to travel
- Good organizational skills
- Ability to deal with competing priorities
- Effective written communication skills
- Effective verbal communication skills
- Effective presentation skills
- Creative thinking
- Curiosity
- Unafraid to ask questions
- Initiating changes
- Introducing new ideas
- Creative problem solving
- Proficiency with MS Office Suite
- Valid driving license
- Ability to work with remote collaborators
- Ability to work in a matrix reporting structure
- Positive approach to managing change
- Seeing change as opportunity for improvement
- Ability to prioritize tasks
- Ability to manage multiple tasks with conflicting deadlines
- Team oriented
- Flexibility to respond to shifting demands
- Flexibility to respond to shifting opportunities
- Bachelor's Degree or equivalent in clinical practice/health care, life sciences or drug development
- Clinical or advanced degree preferred
- 3+ years of relevant experience gained with a CRO or pharmaceutical company
- Experience working on clinical studies
- Lead CRA experience preferred
- Senior CRA experience preferred
- Management experience preferred
Aufgaben
- Ensure study compliance with GCP and regulatory requirements
- Collaborate with SSU manager, CSA, and CRAs to meet study commitments
- Interact with Regulatory Authorities and Ethics Committees
- Support submission and approval processes for projects
- Ensure site activation requirements are met
- Work with Head of Country Operations and AD COM for study resourcing
- Act as local study manager and monitor
- Perform site monitoring activities and oversight
- Deliver quality and timely study deliverables
- Report study-specific issues to global and country teams
- Ensure quality of monitoring oversight
- Meet recruitment targets for studies
- Negotiate and deliver CDAs based on pre-approved parameters
- Customize ICFs at country/site level
- Negotiate site study contracts and budgets
- Review local regulatory documentation
- Manage relationships with national coordinating investigators
- Coordinate country-level engagement activities
- Lead recruitment discussions locally
- Respond to study team queries
- Conduct site feasibility assessments
- Submit and resolve EC/CA queries
- Coordinate study-specific training of CRAs
- Oversee dedicated or FSP CRAs
- Review clinical monitoring documentation
- Coordinate inspection readiness activities
- Identify and manage risks to study quality
- Perform selection, initiation, interim, and closeout visits
- Conduct remote data checks
- Drive site performance
- Resolve study-related issues proactively
- Escalate issues as appropriate
- Train and support investigators and site staff
- Develop and manage recruitment plans
- Document recruitment barriers and mitigation plans
- Ensure monitoring KPIs are within acceptable ranges
- Prepare and finalize monitoring visit reports
- Collect and upload essential documents into eTMF
- Support regular QC checks of eTMF
- Collaborate with local Medical Affairs and other stakeholders
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office Suite
- Excel
- Word
- PowerPoint
- ICH-GCP
- GMP
- GDP
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BP13 Alexion Pharma Germany Company 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
BP13 Alexion Pharma Germany Company
Branche
Pharmaceuticals
Beschreibung
Alexion is committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.
Noch nicht perfekt?
- Alexion
Clinical Research Associate(m/w/x)
Vollzeitnur vor OrtManagementMünchen - Alexion Pharma Germany Company
Senior Clinical Study Administrator(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - GlaxoSmithKline GmbH & Co. KG
Projektleiter*in Klinische Forschung - LDL (Local Delivery Lead)(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - GlaxoSmithKline GmbH & Co. KG
Heme Clinical Trial RMAM(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMünchen - GlaxoSmithKline GmbH & Co. KG
Heme Clinical Trial RMAM(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMünchen