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129 Treffer für Clinical Research Jobs in Planegg im Umkreis von 30 km
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Associate Director Regulatory Affairs – CMC Lead*
Associate Director Regulatory Affairs – CMC Lead*
Immatics Biotechnologies GmbH
Tübingen, München, Home-Office
Teilweise Home-Office
In this role, you will provide strategic CMC regulatory leadership for innovative oncology biopharmaceutical and ATMP programs across clinical development phases. You will independently lead EU CMC regulatory strategy and execution for assigned programs across early and late-stage clinical development. * Own EU CMC regulatory strategy for assigned clinical-stage programs (phase I–III). * Lead preparation and coordination of CMC/ GMP documentation for submission of initial clinical trial applications as well as Substantial Modifications. * Strong experience preparing CMC-related information/ documents for clinical trial applications and supporting Health Authority interactions.
In this role, you will provide strategic CMC regulatory leadership for innovative oncology biopharmaceutical and ATMP programs across clinical development phases. You will independently lead EU CMC regulatory strategy and execution for assigned programs across early and late-stage clinical development. * Own EU CMC regulatory strategy for assigned clinical-stage programs (phase I–III). * Lead preparation and coordination of CMC/ GMP documentation for submission of initial clinical trial applications as well as Substantial Modifications. * Strong experience preparing CMC-related information/ documents for clinical trial applications and supporting Health Authority interactions.
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Studienassistentin / Studienassistent (m/w/d) - ECTU - Hämatologie und Onkologie
Studienassistentin / Studienassistent (m/w/d) - ECTU - Hämatologie und Onkologie
TUM Klinikum Rechts der Isar
München
Als Studienassistentin / Studienassistent (m/w/d) in unserer Early Clinical Trial Unit (ECTU) für frühe Phase I/II-Studien tragen Sie dazu bei, dass Tumorpatient*innen eine intensive klinische Versorgung mit innovativen Therapiekonzepten in enger Zusammenarbeit mit unseren erhalten.
Als Studienassistentin / Studienassistent (m/w/d) in unserer Early Clinical Trial Unit (ECTU) für frühe Phase I/II-Studien tragen Sie dazu bei, dass Tumorpatient*innen eine intensive klinische Versorgung mit innovativen Therapiekonzepten in enger Zusammenarbeit mit unseren erhalten.
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Schnelle Bewerbung
Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research * Ability to apply advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information - You will contribute to statistical activities related to global clinical trials and work closely with international teams of , and , including the role of biostatistics project lead * Conduct statistical analysis for clinical trials including, interim analysis, final analysis, analysis for DSMBs/DMCs and PK analysis * Ability to consult with , interpret research requirements, and determine statistical analysis strategies
Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research * Ability to apply advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information - You will contribute to statistical activities related to global clinical trials and work closely with international teams of , and , including the role of biostatistics project lead * Conduct statistical analysis for clinical trials including, interim analysis, final analysis, analysis for DSMBs/DMCs and PK analysis * Ability to consult with , interpret research requirements, and determine statistical analysis strategies
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Lead - Clinical Data Manager / Data Analytics
Lead - Clinical Data Manager / Data Analytics
ConvaTec (Germany) GmbH
Munich, Germany
Teilweise Home-Office
4-6 years of experience in clinical data management or a similar role in the medical device or clinical research industry. Position OverviewThe Lead Clinical Data Manager (LCDM) is accountable for clinical data management activities in support of the clinical pipeline for complex studies. This includes, but is not limited to, execution and ownership of the CDM operating model, oversight of internal staff (dotted line), and cross-functional leadership for the delivery of high quality and reliable clinical data to enable internal decision making, regulatory approval, and market acceptance. The LCDM interacts with senior level management, collaboration partners and provides cross functional strategic direction and is accountable for leading the data management activities for complex studies (i.e. Pearls) across functions to identify risks and opportunities as well as innovative ...
4-6 years of experience in clinical data management or a similar role in the medical device or clinical research industry. Position OverviewThe Lead Clinical Data Manager (LCDM) is accountable for clinical data management activities in support of the clinical pipeline for complex studies. This includes, but is not limited to, execution and ownership of the CDM operating model, oversight of internal staff (dotted line), and cross-functional leadership for the delivery of high quality and reliable clinical data to enable internal decision making, regulatory approval, and market acceptance. The LCDM interacts with senior level management, collaboration partners and provides cross functional strategic direction and is accountable for leading the data management activities for complex studies (i.e. Pearls) across functions to identify risks and opportunities as well as innovative ...
Schnelle Bewerbung
Identify potential investigators in relevant diseases for participation in future clinical research projects and disease registries. He/she combines strong business acumen and clinical expertise and serves as a peer-to-peer liaison internally and externally. * Support the development and drive implementation of a local Medical Affairs Plan and strategy, to support best clinical practice and the overall corporate objectives. * Identify and implement appropriate high-impact medical research projects to support the business objectives, including Alexion–sponsored and investigator-initiated projects.
Identify potential investigators in relevant diseases for participation in future clinical research projects and disease registries. He/she combines strong business acumen and clinical expertise and serves as a peer-to-peer liaison internally and externally. * Support the development and drive implementation of a local Medical Affairs Plan and strategy, to support best clinical practice and the overall corporate objectives. * Identify and implement appropriate high-impact medical research projects to support the business objectives, including Alexion–sponsored and investigator-initiated projects.
Schnelle Bewerbung
Responsibility for the implementation of new medical practices, the evaluation of new indications, analysis of the status quo of current treatment and patient pathways, identification of patients for clinical research, and the development of a deep understanding of the respective indication area. * Development and implementation of the local medical strategy to support clinical practice and the objectives of the overall company.
Responsibility for the implementation of new medical practices, the evaluation of new indications, analysis of the status quo of current treatment and patient pathways, identification of patients for clinical research, and the development of a deep understanding of the respective indication area. * Development and implementation of the local medical strategy to support clinical practice and the objectives of the overall company.
The Country Study Manager (CSM) has local responsibility for the delivery of the studies in compliance with Good Clinical Practice (GCP), and regulatory requirements. The CSM works in close collaboration with Study Start-Up (SSU) manager, Clinical Study Administrator (CSA) and other CRAs in Country Operations Management (COM) to ensure that study commitments are achieved in a timely and efficient manner in the country level. The CSM is responsible for ensuring that all requirements for site activation are in place for the agreed number of centers in clinical studies according to SOPs. * Reviewing Clinical Monitoring Documentation (reports, metrics, etc) for the assigned studies. * Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).
The Country Study Manager (CSM) has local responsibility for the delivery of the studies in compliance with Good Clinical Practice (GCP), and regulatory requirements. The CSM works in close collaboration with Study Start-Up (SSU) manager, Clinical Study Administrator (CSA) and other CRAs in Country Operations Management (COM) to ensure that study commitments are achieved in a timely and efficient manner in the country level. The CSM is responsible for ensuring that all requirements for site activation are in place for the agreed number of centers in clinical studies according to SOPs. * Reviewing Clinical Monitoring Documentation (reports, metrics, etc) for the assigned studies. * Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).
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Schnelle Bewerbung
Since our founding in 1997, we have been awarded three times as the best service provider and the best contract research organization internationally. Some of the key tasks you will be involved with are:- Supporting in the preparation and execution of clinical trials - Procurement of study materials and office supplies
Since our founding in 1997, we have been awarded three times as the best service provider and the best contract research organization internationally. Some of the key tasks you will be involved with are:- Supporting in the preparation and execution of clinical trials - Procurement of study materials and office supplies
NEU
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Associate Director Country Operations Management
Associate Director Country Operations Management
Alexion Pharma Germany GmbH
Germany - Munich
Teilweise Home-Office
Schnelle Bewerbung
Contribute to Country feasibility analysis for new potential clinical trials (as applicable, depending on the direct reports the LM will be managing). Maintain tools to document and track clinical monitoring activities as required.
Contribute to Country feasibility analysis for new potential clinical trials (as applicable, depending on the direct reports the LM will be managing). Maintain tools to document and track clinical monitoring activities as required.
NEU
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Als Clinical Operations Specialist führen und koordinieren Sie Aktivitäten im Zusammenhang mit Einreichungen gemäß ICH GCP, internationalen und lokalen Vorschriften sowie relevanten GSK-Standards.
Als Clinical Operations Specialist führen und koordinieren Sie Aktivitäten im Zusammenhang mit Einreichungen gemäß ICH GCP, internationalen und lokalen Vorschriften sowie relevanten GSK-Standards.
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Partner across Patient Safety to drive compliance for post-marketing and clinical trial safety activities and uphold company policies and standards.
Partner across Patient Safety to drive compliance for post-marketing and clinical trial safety activities and uphold company policies and standards.
PSI is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation to both clients and employees. We are looking for a person, who would lead the risk-based monitoring approach implementation on the clinical study and program level to ensure patient safety and data integrity. * Communicate study challenges to Clinical Data Science group and work out data-driven solutions * Clinical Study Lead/Manager experience * Knowledge of theprocessand functions in clinical trials, ability to understand the protocol and study associated risks
PSI is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation to both clients and employees. We are looking for a person, who would lead the risk-based monitoring approach implementation on the clinical study and program level to ensure patient safety and data integrity. * Communicate study challenges to Clinical Data Science group and work out data-driven solutions * Clinical Study Lead/Manager experience * Knowledge of theprocessand functions in clinical trials, ability to understand the protocol and study associated risks
Noch nichts dabei? Es gibt 117 weitere Jobs, die zu deiner Suche passen könnten
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As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. * Act as Systems Integration SME within one of the research and development project teams in the field of Total Laboratory Automation. * 3 – 5 years of professional experience in highly Technological Industries, preferably in the domain of Clinical Diagnostics, Medical Technologies, or Industrial Automation. * Clinical Diagnostics Analyzers and Clinical Laboratory workflows (Hema, CIA, UA).
As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. * Act as Systems Integration SME within one of the research and development project teams in the field of Total Laboratory Automation. * 3 – 5 years of professional experience in highly Technological Industries, preferably in the domain of Clinical Diagnostics, Medical Technologies, or Industrial Automation. * Clinical Diagnostics Analyzers and Clinical Laboratory workflows (Hema, CIA, UA).
As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.
As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.
NEU
As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.
As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.
As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.
As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.
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We work at the intersection of artificial intelligence, hardware, software, and clinical innovation, building products that enhance diagnose precision and improve patient outcomes. We are an ambitious, international team, moving fast, learning constantly, and developing AI-driven technologies that support surgeons in some of the most demanding clinical environments. * Prepare presentations, analyses, and decision-support materials * Conduct research to support strategic decisions
We work at the intersection of artificial intelligence, hardware, software, and clinical innovation, building products that enhance diagnose precision and improve patient outcomes. We are an ambitious, international team, moving fast, learning constantly, and developing AI-driven technologies that support surgeons in some of the most demanding clinical environments. * Prepare presentations, analyses, and decision-support materials * Conduct research to support strategic decisions
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Schnelle Bewerbung
Parts of our apps need to be rebuilt from scratch, the user experience has room to grow significantly, and we believe that great product work can push real-world outcomes well beyond what our clinical studies already proved. * User research as a reflex: Spinning up an AI prototype, putting it in front of a patient, and coming back with insights: That's not a process for you, it's just a Tuesday morning. You don't need a research sprint or a UX designer to test something.
Parts of our apps need to be rebuilt from scratch, the user experience has room to grow significantly, and we believe that great product work can push real-world outcomes well beyond what our clinical studies already proved. * User research as a reflex: Spinning up an AI prototype, putting it in front of a patient, and coming back with insights: That's not a process for you, it's just a Tuesday morning. You don't need a research sprint or a UX designer to test something.
Ensure all research is executed and documented according to good clinical practice and highest industry standards as well as local governance requirements. As a member of Medical Affairs organisation, you'll collaborate with cross-functional teams to shape clinical practice, engage with , and deliver on our promise to help people do more, feel better, and live longer. * Advise and oversee the medical affairs led evidence generation for the German organization including the design of real-world evidence (RWE) studies (e.g., non-interventional, observational, data base studies, systematic literature) to address research questions across the portfolio and in close collaboration with the respective Therapeutic Area Head/ Medical Affairs Lead. * MD (or equivalent clinical qualification).
Ensure all research is executed and documented according to good clinical practice and highest industry standards as well as local governance requirements. As a member of Medical Affairs organisation, you'll collaborate with cross-functional teams to shape clinical practice, engage with , and deliver on our promise to help people do more, feel better, and live longer. * Advise and oversee the medical affairs led evidence generation for the German organization including the design of real-world evidence (RWE) studies (e.g., non-interventional, observational, data base studies, systematic literature) to address research questions across the portfolio and in close collaboration with the respective Therapeutic Area Head/ Medical Affairs Lead. * MD (or equivalent clinical qualification).
Conceptualize and coordinate engagement of PAOs in clinical development programs running and/or planned in Germany * Most importantly, a passion for patients and research
Conceptualize and coordinate engagement of PAOs in clinical development programs running and/or planned in Germany * Most importantly, a passion for patients and research
Schnelle Bewerbung
Conceptualize and coordinate engagement of PAOs in clinical development programs running and/or planned in Germany * Most importantly, a passion for patients and research
Conceptualize and coordinate engagement of PAOs in clinical development programs running and/or planned in Germany * Most importantly, a passion for patients and research
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As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.
As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.
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Furthermore, you drive the implementation of scalable AI software platforms using state-of-the-art AI research and leveraging our in-house software stacks.
Furthermore, you drive the implementation of scalable AI software platforms using state-of-the-art AI research and leveraging our in-house software stacks.
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Schnelle Bewerbung
Sentec AG * München * Feste Anstellung * Vollzeit - Sei einer der ersten Bewerber - Schnelle Bewerbung - Sentec ist ein schweizerisch-amerikanisches Medizintechnikunternehmen, das sich auf die Beatmungsmedizin spezialisiert. Seit seiner Gründung im Jahr 1999 verfolgt Sentec einen Deep-Tech-Ansatz, der auf fortschrittlicher Wissenschaft und avantgardistischen Technologien basiert, um Patienten mit Atemwegserkrankungen in allen Pflegebereichen zu versorgen. Sentec bietet medizinischen Fachkräften auf der ganzen Welt nicht-invasive, kontinuierliche Überwachung und effektive therapeutische Lösungen. Sentec erhielt die Auszeichnung ‚Top Company' von Kununu in den Jahren 2025 und 2026. Ihre Aufgaben * Demonstration, Schulung und Einweisung in das Sentec-Portfolio bei klinischen Anwendern vor Ort * Troubleshooting und First-Level-Support für bestehende Kunden
Sentec AG * München * Feste Anstellung * Vollzeit - Sei einer der ersten Bewerber - Schnelle Bewerbung - Sentec ist ein schweizerisch-amerikanisches Medizintechnikunternehmen, das sich auf die Beatmungsmedizin spezialisiert. Seit seiner Gründung im Jahr 1999 verfolgt Sentec einen Deep-Tech-Ansatz, der auf fortschrittlicher Wissenschaft und avantgardistischen Technologien basiert, um Patienten mit Atemwegserkrankungen in allen Pflegebereichen zu versorgen. Sentec bietet medizinischen Fachkräften auf der ganzen Welt nicht-invasive, kontinuierliche Überwachung und effektive therapeutische Lösungen. Sentec erhielt die Auszeichnung ‚Top Company' von Kununu in den Jahren 2025 und 2026. Ihre Aufgaben * Demonstration, Schulung und Einweisung in das Sentec-Portfolio bei klinischen Anwendern vor Ort * Troubleshooting und First-Level-Support für bestehende Kunden
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Schnelle Bewerbung
Our Clinical Graduate Program is designed to help early-career professionals contribute to solutions that transform patient lives. As a part of the Field Clinical Specialist team, you'll play a crucial role in partnering with clinical professionals to deliver our patient-focused therapies including proctoring, training and education. The Clinical Graduate Program starts in October 2026, offering a structured 12-month fixed-term contract. * Intensive Educational Academy: Dive into a 12-month program that enhances your product knowledge, cardiovascular expertise, clinical understanding and fundamental commercial skills. * Hands-On Experience: Work alongside certified Field Clinical Specialists (FCS) to support case coverage, troubleshoot issues, program devices and follow up with patients on our cutting-edge product range.
Our Clinical Graduate Program is designed to help early-career professionals contribute to solutions that transform patient lives. As a part of the Field Clinical Specialist team, you'll play a crucial role in partnering with clinical professionals to deliver our patient-focused therapies including proctoring, training and education. The Clinical Graduate Program starts in October 2026, offering a structured 12-month fixed-term contract. * Intensive Educational Academy: Dive into a 12-month program that enhances your product knowledge, cardiovascular expertise, clinical understanding and fundamental commercial skills. * Hands-On Experience: Work alongside certified Field Clinical Specialists (FCS) to support case coverage, troubleshoot issues, program devices and follow up with patients on our cutting-edge product range.
Beliebte Jobs
- Physiotherapeut Ausbildung
- Industriekaufmann Ausbildung
- Reinigung
- Logopädie Ausbildung
- Kommunikation
- Vertriebsmitarbeiter
- Industriemechaniker Ausbildung
- Verkäufer Ausbildung
- Arzt Ausbildung
- Rettungssanitäter Ausbildung
- Heilpraktiker Ausbildung
- Kfz Mechaniker Ausbildung
- MFA Ausbildung
- English Speaking
- Ausbildung Bauzeichner
- Bauzeichner Ausbildung