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50.965 Treffer für Trial Management Jobs
Your proficiency in MS Office and electronic clinical trial data management systems, e.g. CTMS or eTMF, is expected. Our lead candidate, a tandem CAR-T cell product, is currently undergoing pivotal clinical trials on a global scale. * You coordinate the filing and reconciliation of Trial Master File documents. * You have already gained experience in clinical research as a clinical trial associate, clinical research associate and/or clinical study coordinator in the pharmaceutical/biotech industry. * Working with free and self-determined time management, also mobile working
Your proficiency in MS Office and electronic clinical trial data management systems, e.g. CTMS or eTMF, is expected. Our lead candidate, a tandem CAR-T cell product, is currently undergoing pivotal clinical trials on a global scale. * You coordinate the filing and reconciliation of Trial Master File documents. * You have already gained experience in clinical research as a clinical trial associate, clinical research associate and/or clinical study coordinator in the pharmaceutical/biotech industry. * Working with free and self-determined time management, also mobile working
NEU
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Mehrjährige Berufserfahrung im Bereich Clinical Operations/Clinical Trial Management wünschenswert - Als Clinical Trial Manager (m/w/d) bringst du dein Know-how und deine Expertise ein. * Verantwortung für die Clinical Trial Supply in Zusammenarbeit mit globalen
Mehrjährige Berufserfahrung im Bereich Clinical Operations/Clinical Trial Management wünschenswert - Als Clinical Trial Manager (m/w/d) bringst du dein Know-how und deine Expertise ein. * Verantwortung für die Clinical Trial Supply in Zusammenarbeit mit globalen
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Pharmacovigilance Manager (m/w/d) Manager/in für Arzneimittelsicherheit (m/w/d)
Pharmacovigilance Manager (m/w/d) Manager/in für Arzneimittelsicherheit (m/w/d)
Biofrontera AG
Leverkusen
Sie übernehmen die Verantwortung für den einwandfreien Informationsfluss aller beteiligten internen (z.B. Medical Affairs, Regulatory Affairs, Clinical Trial Management, Quality Management) und externen Partner zur Pharmakovigilanz * Sie unterstützen und reviewen die regelmäßige Berichterstattung und das Risikomanagement * Sie interessieren sich nicht nur für Pharmacovigilance, sondern auch Quality Management Themen * Sie unterstützen die QM-Abteilungen bei Quality-Prozessen wie z.B. Dokumentenlenkung, Abweichungen, Change-Management, Korrektur- und Vorbeugemaßnahmen sowie Schulungen und Dienstleisterqualifizierung
Sie übernehmen die Verantwortung für den einwandfreien Informationsfluss aller beteiligten internen (z.B. Medical Affairs, Regulatory Affairs, Clinical Trial Management, Quality Management) und externen Partner zur Pharmakovigilanz * Sie unterstützen und reviewen die regelmäßige Berichterstattung und das Risikomanagement * Sie interessieren sich nicht nur für Pharmacovigilance, sondern auch Quality Management Themen * Sie unterstützen die QM-Abteilungen bei Quality-Prozessen wie z.B. Dokumentenlenkung, Abweichungen, Change-Management, Korrektur- und Vorbeugemaßnahmen sowie Schulungen und Dienstleisterqualifizierung
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Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. * Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities. * Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs),Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the ...
Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. * Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities. * Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs),Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the ...
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The Clinical Study Administrator (CSA) assists in the coordination of study activities from the start up to execution and close out within Country Operations Management (COM) to ensure quality and consistency of trial deliverables to time, cost and quality objectives according to Good Clinical Practices (GCP), Alexion Standard Operating Procedures (SOPs) and evolving regulatory requirements. The CSA collaborates closely with the Country Operations (PMCO) and other local study team members in COM such as Study Start Up (SSU) manager, Clinical Research Associates (CRA), Site Management Leads (SML) and Head of Country Operations (HCO) in delivering support in the conduct of clinical trials in region or country. * End to end electronic Trial Master File (eTMF) set-up and maintenance, regulatory document tracking, tracking of team training documentation, milestone ...
The Clinical Study Administrator (CSA) assists in the coordination of study activities from the start up to execution and close out within Country Operations Management (COM) to ensure quality and consistency of trial deliverables to time, cost and quality objectives according to Good Clinical Practices (GCP), Alexion Standard Operating Procedures (SOPs) and evolving regulatory requirements. The CSA collaborates closely with the Country Operations (PMCO) and other local study team members in COM such as Study Start Up (SSU) manager, Clinical Research Associates (CRA), Site Management Leads (SML) and Head of Country Operations (HCO) in delivering support in the conduct of clinical trials in region or country. * End to end electronic Trial Master File (eTMF) set-up and maintenance, regulatory document tracking, tracking of team training documentation, milestone ...
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Ensuring compliance with regulatory standards, quality expectations, and best practices in clinical trial data management You will work with clinical trials patient and operational data, develop new data solutions and set up Risk-based Monitoring systems in Process Improvement department. Developing and programming Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Tables, Figures, and Listings (TFLs) to enable proactive trial oversight * Programming and maintaining interactive dashboards and Patient Profiles using R and R Shiny to visualize clinical trial data and support medical review and risk assessment * Advising on and contributing to the development of new tools and methodologies for clinical trial analytics and risk-based monitoring
Ensuring compliance with regulatory standards, quality expectations, and best practices in clinical trial data management You will work with clinical trials patient and operational data, develop new data solutions and set up Risk-based Monitoring systems in Process Improvement department. Developing and programming Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Tables, Figures, and Listings (TFLs) to enable proactive trial oversight * Programming and maintaining interactive dashboards and Patient Profiles using R and R Shiny to visualize clinical trial data and support medical review and risk assessment * Advising on and contributing to the development of new tools and methodologies for clinical trial analytics and risk-based monitoring
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Group Leader – Clinical Operational Excellence (m|f|d)
Group Leader – Clinical Operational Excellence (m|f|d)
Miltenyi Biotec B.V. & Co. KG
Bergisch Gladbach
Teilweise Home-Office
Together with your team you will oversee TMF services, trial oversight- and training requirements for clinical studies, including Key Peformance Indicator management, TMF vendor oversight, and proactive risk mitigation. * In this leadership position, you will collaborate closely with Clinical Trial Management, Data Management, QA, and vendors, providing structured leadership through goal setting, coaching, and performance reviews. * You have a strong track record in sponsor oversight for Phase II/III trials and hands-on TMF (eTMF) management, with measurable improvements in quality, completeness, and timeliness. Our lead candidate, a tandem CAR-T cell product, is currently undergoing pivotal clinical trials on a global scale. * In addition, you will drive innovative approaches with focus on clinical trial oversight-, TMF-, and trial training strategy and ensure best‑practice implementation.
Together with your team you will oversee TMF services, trial oversight- and training requirements for clinical studies, including Key Peformance Indicator management, TMF vendor oversight, and proactive risk mitigation. * In this leadership position, you will collaborate closely with Clinical Trial Management, Data Management, QA, and vendors, providing structured leadership through goal setting, coaching, and performance reviews. * You have a strong track record in sponsor oversight for Phase II/III trials and hands-on TMF (eTMF) management, with measurable improvements in quality, completeness, and timeliness. Our lead candidate, a tandem CAR-T cell product, is currently undergoing pivotal clinical trials on a global scale. * In addition, you will drive innovative approaches with focus on clinical trial oversight-, TMF-, and trial training strategy and ensure best‑practice implementation.
Noch nichts dabei? Es gibt 50958 weitere Jobs, die zu deiner Suche passen könnten
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Starte dein Triales Studium – B.A. Handwerksmanagement bei der Bäckerei Büsch in Düsseldorf und Kamp-Lintfort! Dann ist unser triales Studium gemeinsam mit der Fachhochschule des Mittelstands Köln genau das Richtige für dich!
Starte dein Triales Studium – B.A. Handwerksmanagement bei der Bäckerei Büsch in Düsseldorf und Kamp-Lintfort! Dann ist unser triales Studium gemeinsam mit der Fachhochschule des Mittelstands Köln genau das Richtige für dich!
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Clinical Research Associate (CRA) (m/w/d)
Clinical Research Associate (CRA) (m/w/d)
GBG Forschungs GmbH
Neu-Isenburg bei Frankfurt am Main
Teilweise Home-Office
Planen, durchführen und nachbereiten von PreStudy-, Initiierungs-, Monitoring- und Close-Out-Visiten gemäß Trial Monitoring Plan * Kooperation mit den Bereichen: Medizin, Projektmanagement, Qualitätsmanagement und Datenmanagement für einen reibungslosen Studienablauf
Planen, durchführen und nachbereiten von PreStudy-, Initiierungs-, Monitoring- und Close-Out-Visiten gemäß Trial Monitoring Plan * Kooperation mit den Bereichen: Medizin, Projektmanagement, Qualitätsmanagement und Datenmanagement für einen reibungslosen Studienablauf
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Struktur für Pipeline Management, Forecast, Deal Hygiene und Reporting inkl. Enge Abstimmung mit Marketing für Lead Qualität, Messaging und Kampagnen * Erfahrung mit PLG Motion, Inbound Funnels oder Trial to Paid Motion
Struktur für Pipeline Management, Forecast, Deal Hygiene und Reporting inkl. Enge Abstimmung mit Marketing für Lead Qualität, Messaging und Kampagnen * Erfahrung mit PLG Motion, Inbound Funnels oder Trial to Paid Motion
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Field Clinical Specialist, Transcatheter Heart Valve - Bayern
Field Clinical Specialist, Transcatheter Heart Valve - Bayern
Edwards Lifesciences GmbH
Bad Neustadt, Würzburg, Nürnberg, Erlangen, Bayreuth, Regensburg
Teilweise Home-Office
Working independently in the areas of valve crimping, case management, pre-case planning, post-case management, 3 Mensio management, Therapy Awareness program management and clinical education programs * Develop and continuously improve training curriculum, training materials and training tools, based on clinical trial experience, EW guidelines and SOP * Good written and verbal communication skills, presentation, and interpersonal relationship skills including negotiating and relationship management skills
Working independently in the areas of valve crimping, case management, pre-case planning, post-case management, 3 Mensio management, Therapy Awareness program management and clinical education programs * Develop and continuously improve training curriculum, training materials and training tools, based on clinical trial experience, EW guidelines and SOP * Good written and verbal communication skills, presentation, and interpersonal relationship skills including negotiating and relationship management skills
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Du hast fundierte Erfahrung mit React (State Management, Routing) und Node.js. Wir setzen auf ein fachliches Kennenlernen und einen bezahlten "Paid Trial" (3-5 Tage), damit wir uns im echten Arbeitsalltag beschnuppern können.
Du hast fundierte Erfahrung mit React (State Management, Routing) und Node.js. Wir setzen auf ein fachliches Kennenlernen und einen bezahlten "Paid Trial" (3-5 Tage), damit wir uns im echten Arbeitsalltag beschnuppern können.
Quality Manager (m|f|d) Fixed-term, 24 months
Quality Manager (m|f|d) Fixed-term, 24 months
Miltenyi Biotec B.V. & Co. KG
Bergisch Gladbach
Teilweise Home-Office
Our lead candidate, a tandem CAR-T cell product, is currently undergoing pivotal clinical trials on a global scale. As Quality Manager, you will play a key role in maintaining and enhancing MBM's Quality Management System (QMS) to ensure continuous compliance with applicable GxP regulations, corporate standards, and quality objectives. * You will maintain and continuously improve the QMS, including document and change management, by ensuring all QMS documents (policies, SOPs, work instructions) remain compliant and up to date. * Next to this, you supervise lifecycle management of controlled documents and records by managing QA SharePoint to guarantee accurate and accessible documentation. * You are proficient in deviation management, OOS investigations, CAPA management, change control, and document management under GxP regulations.
Our lead candidate, a tandem CAR-T cell product, is currently undergoing pivotal clinical trials on a global scale. As Quality Manager, you will play a key role in maintaining and enhancing MBM's Quality Management System (QMS) to ensure continuous compliance with applicable GxP regulations, corporate standards, and quality objectives. * You will maintain and continuously improve the QMS, including document and change management, by ensuring all QMS documents (policies, SOPs, work instructions) remain compliant and up to date. * Next to this, you supervise lifecycle management of controlled documents and records by managing QA SharePoint to guarantee accurate and accessible documentation. * You are proficient in deviation management, OOS investigations, CAPA management, change control, and document management under GxP regulations.
NEU
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Erstellung aller erforderlichen Data-Management-Dokumente, einschließlich Data Management Plans (DMP), eCRFs, Annotations und Trial Validation Plans (TVP) * Überwachung der Datenqualität inklusive Query-Managements und Programmierung von Edit Checks (z. B. in SQL) * Sie haben ein abgeschlossenes Studium in Medizinischer Dokumentation, Medizinischer Informatik, Digital Health Management, Health Care Management oder einem naturwissenschaftlichen Studiengang mit entsprechender Weiterbildung. * Erfahrung im Umgang mit eCRF-Systemen sowie Kenntnisse in Datenvalidierung, Edit-Check- Erstellung, Query-Management und der Verarbeitung externer Datenquellen (Labore, ePRO/eCOA etc.)
Erstellung aller erforderlichen Data-Management-Dokumente, einschließlich Data Management Plans (DMP), eCRFs, Annotations und Trial Validation Plans (TVP) * Überwachung der Datenqualität inklusive Query-Managements und Programmierung von Edit Checks (z. B. in SQL) * Sie haben ein abgeschlossenes Studium in Medizinischer Dokumentation, Medizinischer Informatik, Digital Health Management, Health Care Management oder einem naturwissenschaftlichen Studiengang mit entsprechender Weiterbildung. * Erfahrung im Umgang mit eCRF-Systemen sowie Kenntnisse in Datenvalidierung, Edit-Check- Erstellung, Query-Management und der Verarbeitung externer Datenquellen (Labore, ePRO/eCOA etc.)
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Clinical Study Project Management: Take full responsibility for clinical trials in the role as sponsor and of non-interventional healthcare studies in fully outsourced model, steering scope, timelines and budget while safeguarding patient safety and data integrity. Projects comprise clinical trials as well as all types of non-interventional healthcare research. * Completed Study Documentation: Consolidate, finalize and archive the documentation of a recently closed trial, ensuring inspection-readiness. * Experience: Professional experience in clinical research project management (pharmaceutical industry or contract research organization) are an asset, but we are also open for structured and well-organized graduates. * Skills and competencies: Strong project management abilities and skills in MS Office.
Clinical Study Project Management: Take full responsibility for clinical trials in the role as sponsor and of non-interventional healthcare studies in fully outsourced model, steering scope, timelines and budget while safeguarding patient safety and data integrity. Projects comprise clinical trials as well as all types of non-interventional healthcare research. * Completed Study Documentation: Consolidate, finalize and archive the documentation of a recently closed trial, ensuring inspection-readiness. * Experience: Professional experience in clinical research project management (pharmaceutical industry or contract research organization) are an asset, but we are also open for structured and well-organized graduates. * Skills and competencies: Strong project management abilities and skills in MS Office.
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Technical Product Sales Manager - Food Processing & Packaging (m/f/d)
Technical Product Sales Manager - Food Processing & Packaging (m/f/d)
GEA Food Solutions Germany GmbH
Biedenkopf-Wallau
Act as the primary link between offices, customers, , and internal departments (Engineering, Marketing, Order Management, Application Engineers, Planning, Trial Centre) to ensure a smooth sales trajectory * Central management of key global accounts for slicing & packaging, maintaining high-level relationships and understanding their unique business needs
Act as the primary link between offices, customers, , and internal departments (Engineering, Marketing, Order Management, Application Engineers, Planning, Trial Centre) to ensure a smooth sales trajectory * Central management of key global accounts for slicing & packaging, maintaining high-level relationships and understanding their unique business needs
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Partner deeply with Clinical Development to inform future trials and label expansions; collaborate across Regulatory, Manufacturing/CMC, Quality, Commercial, and Market Access - As a trusted advisor to senior leadership, you provide confident counsel on medical strategy, compliance, and risk management.
Partner deeply with Clinical Development to inform future trials and label expansions; collaborate across Regulatory, Manufacturing/CMC, Quality, Commercial, and Market Access - As a trusted advisor to senior leadership, you provide confident counsel on medical strategy, compliance, and risk management.
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Ensure compliance of all products throughout their lifecycle, from authorization to discontinuation and ensure regulatory compliance for product labeling and support clinical trials * Integrate regulatory elements into business processes to minimize approval delays and rejections * Maintain and update regulatory documentation related to Quality Management Systems and assess marketing claims * Strong experience in regulatory affairs and quality management, preferably in medical devices, ideally with experience in standalone or embedded medical device software and IEC 62304, or in pharma * Strong knowledge of regulatory requirements and processes in relevant markets combined with advanced project management skills, time and budget management proficiency in an multicultural environment
Ensure compliance of all products throughout their lifecycle, from authorization to discontinuation and ensure regulatory compliance for product labeling and support clinical trials * Integrate regulatory elements into business processes to minimize approval delays and rejections * Maintain and update regulatory documentation related to Quality Management Systems and assess marketing claims * Strong experience in regulatory affairs and quality management, preferably in medical devices, ideally with experience in standalone or embedded medical device software and IEC 62304, or in pharma * Strong knowledge of regulatory requirements and processes in relevant markets combined with advanced project management skills, time and budget management proficiency in an multicultural environment
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Proven experience in project and/or operations management within the clinical trial industry, ideally in a leadership role. Clariness is looking for a Team Lead Project and Operations Management (f/m/d) based in Berlin or Hamburg. In this role you will be responsible for leading and ensuring the successful delivery of clinical trial recruitment projects across multiple studies and clients. * Leading and supporting to ensure smooth and timely delivery of clinical trial recruitment projects. * Excellent communication and stakeholder management skills. * Good understanding of project management methodologies and tools. * Project management certifications (e.g. PMP, PRINCE2) are a plus. * Impact healthcare by accelerating medical innovation through improved access to clinical trials, potentially bringing needed treatments to patients faster.
Proven experience in project and/or operations management within the clinical trial industry, ideally in a leadership role. Clariness is looking for a Team Lead Project and Operations Management (f/m/d) based in Berlin or Hamburg. In this role you will be responsible for leading and ensuring the successful delivery of clinical trial recruitment projects across multiple studies and clients. * Leading and supporting to ensure smooth and timely delivery of clinical trial recruitment projects. * Excellent communication and stakeholder management skills. * Good understanding of project management methodologies and tools. * Project management certifications (e.g. PMP, PRINCE2) are a plus. * Impact healthcare by accelerating medical innovation through improved access to clinical trials, potentially bringing needed treatments to patients faster.
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Schnelle Bewerbung
People management, including recruiting: Motivate your portcos (portfolio companies), help them achieve their goals, and decide with the team lead who gets hired and when. Creating and improving operations and processes: Each property management company has unique characteristics that you'll need to represent in professional and scalable processes. Product development: New features are constantly built to handle more property management tasks even more effectively in our software. Property management: Here, you'll work hands-on with the largest asset class in the world—and gain insights into what to consider when purchasing your own real estate. There are a bunch of industries within residential real estate that are adjacent to property management and could be interesting. Once you have a deal you'll test it with your portcos, integrate it into the product and finally roll it out across ...
People management, including recruiting: Motivate your portcos (portfolio companies), help them achieve their goals, and decide with the team lead who gets hired and when. Creating and improving operations and processes: Each property management company has unique characteristics that you'll need to represent in professional and scalable processes. Product development: New features are constantly built to handle more property management tasks even more effectively in our software. Property management: Here, you'll work hands-on with the largest asset class in the world—and gain insights into what to consider when purchasing your own real estate. There are a bunch of industries within residential real estate that are adjacent to property management and could be interesting. Once you have a deal you'll test it with your portcos, integrate it into the product and finally roll it out across ...
Senior Clinical Trial Physician (m|f|d)
Senior Clinical Trial Physician (m|f|d)
Miltenyi Biotec B.V. & Co. KG
Bergisch Gladbach
Teilweise Home-Office
We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases. Our lead candidate, a tandem CAR-T cell product, is currently undergoing pivotal clinical trials on a global scale. As a Senior Clinical Trial Physician, you will play a pivotal role in providing medical leadership and scientific expertise to ensure the successful planning, execution, and supervision of clinical trials in hemato-oncology. * You will lead the design and implementation of clinical trial protocols, ensuring adherence to ICH-GCP, ethical standards, and regulatory requirements. * You will provide medical supervision of ongoing trials, working closely with Clinical Operations and Medical Monitors, and support protocol amendments as needed. * You will review and analyze clinical trial data, contributing to ...
We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases. Our lead candidate, a tandem CAR-T cell product, is currently undergoing pivotal clinical trials on a global scale. As a Senior Clinical Trial Physician, you will play a pivotal role in providing medical leadership and scientific expertise to ensure the successful planning, execution, and supervision of clinical trials in hemato-oncology. * You will lead the design and implementation of clinical trial protocols, ensuring adherence to ICH-GCP, ethical standards, and regulatory requirements. * You will provide medical supervision of ongoing trials, working closely with Clinical Operations and Medical Monitors, and support protocol amendments as needed. * You will review and analyze clinical trial data, contributing to ...
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The Medical Monitor is a key clinical expert responsible for ensuring the medical and scientific integrity of clinical trials, overseeing patient safety, and supporting study teams in protocol execution. Reporting to the of Clinical Operations (EU), the Medical Monitor works closely with , investigators, and internal clinical teams to ensure the highest ethical, medical, and regulatory standards throughout the clinical trial lifecycle. The role requires expertise in clinical trial design, medical data interpretation, and regulatory compliance, with a strong focus on patient safety, risk mitigation, and adherence to study protocols. * Provide medical monitoring for clinical trials, ensuring the safety and well-being of study participants. * Assist in the review and interpretation of clinical trial data, ensuring accuracy and relevance.
The Medical Monitor is a key clinical expert responsible for ensuring the medical and scientific integrity of clinical trials, overseeing patient safety, and supporting study teams in protocol execution. Reporting to the of Clinical Operations (EU), the Medical Monitor works closely with , investigators, and internal clinical teams to ensure the highest ethical, medical, and regulatory standards throughout the clinical trial lifecycle. The role requires expertise in clinical trial design, medical data interpretation, and regulatory compliance, with a strong focus on patient safety, risk mitigation, and adherence to study protocols. * Provide medical monitoring for clinical trials, ensuring the safety and well-being of study participants. * Assist in the review and interpretation of clinical trial data, ensuring accuracy and relevance.
Manages clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory. * Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones. * Updates management accurately and regularly through frequent communication. * Assists in TMF management and manages TMF reviews as needed. * 3 years of experience in the pharmaceutical / biotechnology / CRO industry with 1 year of management experience * Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
Manages clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory. * Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones. * Updates management accurately and regularly through frequent communication. * Assists in TMF management and manages TMF reviews as needed. * 3 years of experience in the pharmaceutical / biotechnology / CRO industry with 1 year of management experience * Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
NEU
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Unterstützung im Bereich Clinical Trial Services (CTS), insbesondere bei der Versorgung mit Referenzpräparaten für klinische Studien * Je nach Erfahrung: Koordination von Prozessen im Qualitätsmanagementsystem (QMS)
Unterstützung im Bereich Clinical Trial Services (CTS), insbesondere bei der Versorgung mit Referenzpräparaten für klinische Studien * Je nach Erfahrung: Koordination von Prozessen im Qualitätsmanagementsystem (QMS)
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The responsibility of a Senior Biostatistician is to manage all statistical aspects which occur in the frame of a clinical trial - from initial consultation regarding study concepts, to providing input into study protocols and writing SAPs, to conducting the analysis and summarizing the results. * Statistical aspects throughout the entire course of clinical trials including establishment of qualification control tools and coordination of study processes * Excellent communication and self-management skills * Excellent understanding of regulatory requirements of clinical trials, with a particular focus on statistical requirements * A young and innovative corporate culture and management, with a clear path to personal development and the opportunity to take responsibility not only within projects, but also within the company
The responsibility of a Senior Biostatistician is to manage all statistical aspects which occur in the frame of a clinical trial - from initial consultation regarding study concepts, to providing input into study protocols and writing SAPs, to conducting the analysis and summarizing the results. * Statistical aspects throughout the entire course of clinical trials including establishment of qualification control tools and coordination of study processes * Excellent communication and self-management skills * Excellent understanding of regulatory requirements of clinical trials, with a particular focus on statistical requirements * A young and innovative corporate culture and management, with a clear path to personal development and the opportunity to take responsibility not only within projects, but also within the company
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