46 Jobs für Risk Investigator
Stellenangebote Risk Investigator Jobs
Job vor 9 Tagen bei StepStone gefunden
HMNC Holding GmbH
• München
Homeoffice möglich
[. .. ] authorities. The role requires someone who has worked in or closely with the pharmaceutical industry and understands how development decisions are made under real-world constraints of time, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] budget, regulatory risk, and clinical feasibility. At the same time, the person must understand the mindset and expectations of regulatory authorities and be able to prepare persuasive, scientifically sound documentation, briefing materials, position papers, and responses to authority questions. Lead HMNCs clinical pharmacology and DMPK strategy across pipeline programs, ensuring alignment with clinical [. .. ] studies, including formulation, food effect, drug interaction, QT/ QTc, organ impairment, and special population assessments where applicable. Prepare, review, and challenge key development and regulatory documents, including protocols, study reports, investigator brochures, briefing packages, INd/CTA/ IMPD documents, CTD sections, authority responses, and scientific position papers. Support preparation for and participation in interactions with Bf Ar M, EMA, FDA, and other relevant authorities, including development of clear scientific arguments and response strategies. Advise on nonclinical DMPK, ADME, pharmacology, toxicology, and translational data [. .. ]
Job am 13.06.2026 bei Jobleads gefunden
Global Medical Director
• Allschwil, Basel- Landschaft
Führungs-/ Leitungspositionen
[. .. ] our headquarters in Allschwil, Switzerland. Your tasks Serve as Medical Director for the ongoing Fosmanogepix Phase III programme, providing leadership in safety oversight, eligibility assessment, medical data [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] review, query resolution, risk indicator monitoring, blinding oversight, and protocol/ document review. Ensure robust oversight of external medical monitoring activities at Clinical Research Organisations and manage external consultants. Build and maintain investigator networks to accelerate enrolment in the Fosmanogepix Phase III programme, working closely with the Clinical Study Team. Contribute to strategic planning, including Fosmanogepix positioning, clinical development plans, and competitor analysis. Support the Fosmanogepix Expanded Access Program. Act as a key medical interface with the Medical and Global Affairs department to [. .. ]
Job am 08.06.2026 bei Jobleads gefunden
• Allschwil, Basel- Landschaft
Führungs-/ Leitungspositionen
[. .. ] department for our headquarter in Allschwil, Switzerland. Serve as Medical Director for the ongoing Fosmanogepix Phase III programme, providing leadership in safety oversight, eligibility assessment, medical data [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] review, query resolution, risk indicator monitoring, blinding oversight, and protocol/ document review. Ensure robust oversight of external medical monitoring activities at Clinical Research Organisations and manage external consultants Build and maintain investigator networks to accelerate enrolment in the Fosmanogepix Phase III programme, working closely with the Clinical Study Team Contribute to strategic planning, including Fosmanogepix positioning, clinical development plans, and competitor analysis Support the Fosmanogepix Expanded Access Program Act as a key medical interface with the Medical and Global Affairs department to [. .. ]
Job am 15.01.2026 bei Jobleads gefunden
Senior/ Medical Director (Ophthalmology) 0.5 FTE
Führungs-/ Leitungspositionen
[. .. ] and answering complex questions related to medical, legal, and regulatory concerns. Responsibilities Expert Guidance: Provide advanced medical input on study design, measurement strategies, and trial protocols, including [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] safety sections and investigator brochures. Comprehensive Safety Oversight: Review safety data such as adverse events, labs, vital signs, ECGs, and clinical trial reports from a medical perspective. Regulatory Risk Support: Conduct senior-level medical reviews of individual cases, cumulative listings, PSURs, PBRERs, DSURs, and Risk Management Plans. Medical Monitoring Signal Detection: Serve as a medical monitor in trials, perform literature reviews, and contribute to signal detection and interpretation. Regulatory Document Contributions: Offer expert medical insight into regulatory submissions and [. .. ]
Neu Job vor 3 Std. bei Jobleads gefunden
• Hamburg
[. .. ] SMM; develop and implement compliance improvement initiatives. Provide country-level consultation during RIST, inspections, and audits; act as audit coordinator for internal audits and serve as SME during [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] sponsor and investigator site inspections. Act as a key member throughout the inspection process, including consultation for inspection responses. Analyze quality metrics and trends to improve performance and proactively manage issues. Participate in regional CT SMM leadership teams and facilitate quality review meetings. Identify, track, and elevate compliance risks; support risk mitigation activities and manage country quality risk registers. Escalate significant issues or risks to the Director, Cell Therapy Quality Management. Your Profile You bring a strong foundation in science and quality management, combined with handson experience in clinical operations. Ideally, you have: A Bachelor of Science in a relevant discipline [. .. ]
Neu Job vor 3 Std. bei Jobleads gefunden
Sr Manager/ Associate Director, Clinical Quality Assurance
Führungs-/ Leitungspositionen
[. .. ] for assigned studies, ensuring compliance with Good Clinical Practice (GCP) in collaboration with Clinical Development and CROs. Oversee and execute CQA audit planning and perform GCP and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] PV audits of investigator sites, CROs, and electronic system providers (SAAS) . Support Clinical Operations in the assembly, maintenance, and archiving of study Trial Master Files (TMFs) and systems. Ensure ongoing qualification of GCP and Good Pharmacovigilance Practice (GVP) vendors and systems. Prepare and negotiate Quality Agreements with CROs, where applicable. Manage study, GCP [. .. ] ensure alignment within the QMS and regulatory compliance. Participate in and assist in the preparation for regulatory inspections (e. g. , BIMO) of sponsors, CROs, and investigator sites, based on risk. Advise stakeholders on GCP and GVP compliance issues. Prepare Key Performance Indicators (KPIs) for performance monitoring and Management Oversight. Contribute to the development and approval of CQA, GCP, and GVP Standard Operating Procedures (SOPs) . Assist in providing GCP training to staff. Support departmental Gx P activities and projects. Essential Skills [. .. ]
Neu Job vor 3 Std. bei Jobleads gefunden
Führungs-/ Leitungspositionen
[. .. ] for assigned studies, ensuring compliance with Good Clinical Practice (GCP) in collaboration with Clinical Development and CROs. Oversee and execute CQA audit planning and perform GCP and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] PV audits of investigator sites, CROs, and electronic system providers (SAAS) . Support Clinical Operations in the assembly, maintenance, and archiving of study Trial Master Files (TMFs) and systems. Ensure ongoing qualification of GCP and Good Pharmacovigilance Practice (GVP) vendors and systems. Prepare and negotiate Quality Agreements with CROs, where applicable. Manage study, GCP [. .. ] ensure alignment within the QMS and regulatory compliance. Participate in and assist in the preparation for regulatory inspections (e. g. , BIMO) of sponsors, CROs, and investigator sites, based on risk. Advise stakeholders on GCP and GVP compliance issues. Prepare Key Performance Indicators (KPIs) for performance monitoring and Management Oversight. Contribute to the development and approval of CQA, GCP, and GVP Standard Operating Procedures (SOPs) . Assist in providing GCP training to staff. Support departmental Gx P activities and projects. Essential Skills [. .. ]
Job gestern bei Jobleads gefunden
Assoc Director, Clinical Risk Management
• Allschwil, Basel- Landschaft
Führungs-/ Leitungspositionen
Position Overview Join our R D Quality Clinical
Risk Management team to coordinate identification, assessment, and mitigation of quality risks that could impact trial data integrity, patient safety, and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] regulatory compliance across multiple therapeutic areas. Key Responsibilities Actively and independently participate in all study activities, contributing to the identification and assessment of key risks in the clinical protocol/ setup [. .. ] prepare sites of interest for inspection (including preinspection visit support) , ensure availability of key documents/ records and coordinate mock inspections in collaboration with Regulatory Compliance teams. Provide support for Investigator, Sponsor Monitor and thirdparty inspections including postinspection support. Provide independent advice on questions related to research quality and compliance from clinical teams in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy. Participate in Clinical risk Management, cross R D quality, [. .. ]
Job gestern bei Jobleads gefunden
• Allschwil, Basel- Landschaft
Führungs-/ Leitungspositionen
Job Title Associate Director, Cross Therapeutic Area Clinical
Risk Management Overview The Associate Director, Cross TA Clinical Risk Management, works with trial teams and/or program teams to coordinate the [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] identification, assessment, and mitigation of quality risks that could impact trial data integrity, patient safety, wellbeing, or rights. Throughout the duration of the trial or program, this role executes [. .. ] prepare sites of interest for inspection (including preinspection visit support) , ensure availability of key documents/ records and coordinate mock inspections in collaboration with Regulatory Compliance teams. Provides support for Investigator, Sponsor Monitor and thirdparty inspections including postinspection support. Provides independent advice on questions related to research quality and compliance from clinical teams in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy. Participates in Clinical risk Management, cross R D quality, [. .. ]
Job vor 7 Tagen bei Jobleads gefunden
Senior Clinical Pharmacologist (m/w/d)
• München, Bayern
[. .. ] competent authorities. The role requires someone who has worked in or closely with the pharmaceutical industry and understands how development decisions are made under realworld constraints of [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] time, budget, regulatory risk, and clinical feasibility. At the same time, the person must understand the mindset and expectations of regulatory authorities and be able to prepare persuasive, scientifically sound documentation, briefing materials, position papers, and responses to authority questions. Responsibilities Lead HMNCs clinical pharmacology and DMPK strategy across pipeline programs, ensuring alignment with [. .. ] studies, including formulation, food effect, drug interaction, QT/ QTc, organ impairment, and special population assessments where applicable. Prepare, review, and challenge key development and regulatory documents, including protocols, study reports, investigator brochures, briefing packages, INd/CTA/ IMPD documents, CTD sections, authority responses, and scientific position papers. Support preparation for and participation in interactions with Bf Ar M, EMA, FDA, and other relevant authorities, including development of clear scientific arguments and response strategies. Advise on nonclinical DMPK, ADME, pharmacology, toxicology, and translational data [. .. ]
Job vor 10 Tagen bei Jobleads gefunden
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
[. .. ] with country regulations and clinical practice. Build and maintain strong relationships with national and regional key opinion leaders, oncology networks, academic institutions, and scientific societies. Lead scientific [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] exchange, advisory boards, investigator and other external meetings, press conferences, and congress engagement at country level. Collaborate effectively with Midsized Markets, Regional and Global teams by contributing to overall medical affairs strategy, strongly partnering with local, regional and global clinical development and operations teams. Drive local medical strategy across prelaunch, launch, and postlaunch phases. [. .. ] culture of scientific rigor, compliance, and collaboration. Ensure all medical activities comply with local regulations, national and regional codes, and internal company policies. Represent Medical Affairs in country governance and risk management forums. Required Skills, Experience and Education Advanced degree required (MD, Ph D, or Pharm D) . Strong background and experience in oncology required. 10+ years experience in Medical Affairs with a track record of country leadership. Proven value and benefit assessment experience, with deep understanding of Switzerland payer decisionmaking. Strong stakeholder [. .. ]
Job vor 13 Tagen bei Jobleads gefunden
Study Physician
• Biberach an der Riß, Baden- Württemberg
[. .. ] compliant, and scientifically strong CTPs. Define trialspecific clinical quality monitoring concepts, contribute to project standards, and identify critical data and processes for riskbased quality management within the [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Integrated Quality and Risk Management Plan. Accountable for the medical content of key study documents, including the Trial Communication Plan, Trial Training Plan and Vendor Oversight Plan, and ensure medical accuracy in protocol deviation reviews and CQMP execution. Lead ongoing medical data review, provide input into e CRF design, automated query rules, patient information, informed [. .. ] the BI Code of Conduct, Corporate Medicine SOPs and major industry association codes is expected. First experience with ICHGCP and relevant regulatory guidance is valuable; experience as a clinical trial investigator is an additional asset. Strong ability to set direction, innovate, and communicate in a global environment with diverse internal and external stakeholders. Proven ability to build strong relationships, combined with experience using data visualization and IT systems, strong communication skills, analytical thinking, structured working style, and fluency in English. [. .. ]
Job vor 13 Tagen bei Jobleads gefunden
• Neuss, Nordrhein- Westfalen
[. .. ] seeking a Senior Site Contract Manager (CCS) to join our team located in Germany. In this role you will be responsible for the development and analysis of [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] contractual relationships including investigator grants and may be involved with contract negotiations, providing support to the clinical team in pricing, planning, execution, and control of grants and contracts. Principal Responsibilities Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company-sponsored and/or investigator-initiated studies through direct negotiation or oversight of [. .. ] legal provisions in conjunction with members of the CCS team and support functions and communicate such to stakeholders. Liaise with CCS management and functional CCS support teams, legal, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate. Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites. Mentor and train new contract coordinators and analysts. Assume responsibility for all aspects [. .. ]
Job vor 14 Tagen bei Jobleads gefunden
Leiterin (m/w/d) Qualitätssicherungseinheit des Sponsors der Medizinischen Fakultät OWL
• Bielefeld, Nordrhein- Westfalen
Abgeschlossenes Studium
Flexible Arbeitszeiten
[. .. ] Ausbau und Pflege des Sponsor-Qualitätsmanagements und Sponsor SOP-Managements in Zusammenarbeit mit den Trägerkliniken des Universitätsklinikums OWL Koordination des Antragsverfahrens und der Bewertung zur Übernahme der universitären Sponsorenrolle [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] für Investigator-initiierteklinische Studien (IITs) Weiterentwicklung der standardisierten Risikobewertung, der Vendorenqualifikation und des Sponsor-Oversights im Rahmen der Übernahme der Sponsorenrolle Beratung und Unterstützung der Prüfärztinnen und Prüfärzte sowie der Studienzentren in Qualitäts- und Gx P-Fragen Prüfung sponsorrelevanter Dokumente (z. B. Prüfpläne, SOPs, Monitoringkonzepte, Risikobewertungen) Planung, Durchführung und Nachverfolgung von internen und [. .. ] Planung und Durchführung von Computer System Validierungen (GAMP5) Ihr Profil abgeschlossenes Hochschulstudium (Staatsexamen, Diplom, (Uni) / Master) der Humanmedizin oder eines anderen einschlägigen natur-oder gesundheitswissenschaftlichen Studiengangs mehrjährige Berufserfahrung im Risk-Based Quality Management in der klinischen Forschung (QMS, CAPA, Risikomanagement) , idealerweise auch im universitären oder akademischen Umfeld weitreichende Erfahrung in der Planung, Organisation, Finanzierung und Projektmanagement von IITs fundierte Kenntnisse der relevanten Regularien (u. a. ICH-GCP, EU-CTR, AMG und MDR/ MPDG) Erfahrung in der regulatorischen Beratung bei [. .. ]
Job vor 14 Tagen bei Jobleads gefunden
• Planegg, Bayern
[. .. ] strategy supporting our clinical development programs. Responsibilities Provide medical expertise and judgement in safety surveillance activities including periodic safety reports, safety signal detection, and in creation and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] updates of development risk management plans. Evaluate and manage risks associated with assigned projects and make recommendations for the management communication of risks, in accordance with global legal and regulatory frameworks. Lead the Signal Detection process for the Catal Ym projects Provide Safety medical expertise and judgement in the production of high quality and [. .. ] queries from all sources, including Regulatory Authorities. Provide medical expertise and judgement to Project Teams with respect to safety aspects of the design and preparation of trial protocols, investigators brochures, investigator letters and reports, for the follow up and processing of clinical trial data and lead the safety analyses of the assigned projects. Provide medical Safety input during development of relevant SOPs, working instructions, and guidelines. Owner of the Catal Ym Safety System within the overall Quality Management System Your profile [. .. ]
Job vor 14 Tagen bei Jobleads gefunden
Study Physician
• Biberach an der Riß, Baden- Württemberg
[. .. ] team to deliver accurate, compliant, and scientifically strong CTPs. Moreover, you will define trial specific clinical quality monitoring concepts, contribute to project standards, and identify critical data [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] and processes for risk-based quality management within the Integrated Quality and Risk Management Plan. Furthermore, you will be accountable for the medical content of key study documents, including the Trial Communication Plan, Trial Training Plan and Vendor Oversight Plan, and you will ensure medical accuracy in protocol deviation reviews and CQMP execution. In [. .. ] the BI Code of Conduct, Corporate Medicine SOPs and major industry association codes is expected First experience with ICHGCP and relevant regulatory guidance is valuable; experience as a clinical trial investigator is an additional asset Strong ability to set direction, innovate, and communicate in a global environment with diverse internal and external stakeholders Proven ability to build strong relationships, combined with experience using data visualization and IT systems, strong communication skills, analytical thinking, structured working style, and fluency in English [. .. ]
Job am 14.06.2026 bei Jobleads gefunden
• Frankfurt, Hesse
[. .. ] basis of the relevant medical device and pharmaceutical legislation, regulations, standards and guidelines. Audit Programs Planning and performance of various clinical medical devices and medicinal products project [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] audits (e. g. investigator site audits, process audits, TMF audits, CSP/ CSR audits) against Gx P and local regulatory requirements. Creating audit plans for studies based on risk assessments/ analyses. Planning and performance of internal process and vendor audits. Quality Issue Management Lead the evaluation and management of clinical sitespecific escalations related to persistent or serious misconduct. Quality Management System Collaboration in further development and maintenance of the R D quality management system (document management, CAPA, deviation and [. .. ]
Job am 09.06.2026 bei Jobleads gefunden
Professorship in Clinical Computational Cancer Biology (W3) (f/m/d)
• Köln, Nordrhein- Westfalen
[. .. ] the DKFZ, excellent partners in university medicine, and other outstanding research partners at various locations in Germany. The primary mission of the NCT is to design, prepare [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] and conduct innovative investigator-initiated clinical trials (IITs) that aim to significantly improve the outcome and quality of life of cancer patients. YOUR TASKS Within the framework of this professorship, you will lead a DKFZ research division within the NCT. You will analyze comprehensive, high-quality datasets and develop algorithms for the NCT-IIT program. In particular, machine learning methods should be developed to better understand inter-and intra-tumoral heterogeneity and evolution, chromosomally unstable tumors, as well as for risk stratification and early detection. Furthermore, the professorship will play a leading role in establishing suitable datasets in the NCT/ SUDO databases to monitor parameters of clinical trials. Additionally, key elements for big-and deep-data analyses from clinical trials and tumor tissue samples databases will be provided. The program will [. .. ]
Job am 07.06.2026 bei Jobleads gefunden
Senior Safety Physician
• München, Bayern
[. .. ] strategy supporting our clinical development programs. Responsibilities Provide medical expertise and judgement in safety surveillance activities including periodic safety reports, safety signal detection, and in creation and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] updates of development risk management plans. Evaluate and manage risks associated with assigned projects and make recommendations for the management communication of risks, in accordance with global legal and regulatory frameworks. Lead the Signal Detection process for the Catal Ym projects. Provide Safety medical expertise and judgement in the production of high quality and [. .. ] to safety queries from all sources, including Regulatory Authorities. Provide medical expertise and judgement to Project Teams with respect to safety aspects of the design and preparation of trial protocols, investigator brochures, investigator letters and reports, for the follow up and processing of clinical trial data and lead the safety analyses of the assigned projects. Provide medical Safety input during development of relevant SOPs, working instructions, and guidelines. Owner of the Catal Ym Safety System within the overall Quality Management System. [. .. ]
Job am 05.06.2026 bei Jobleads gefunden
Sr Director, Country Site Operations (CSO)
• Baar, Zug
Führungs-/ Leitungspositionen
[. .. ] and Senior Managers and is accountable for countrylevel execution, issue resolution, and continuous performance improvement. The CCSL fieldbased is a core pillar of the role, with accountability [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] for maintaining strong investigator and site relationships, driving site intelligence, and reinforcing Biogens position as a sponsor of choice through scientific and operational engagement directly tied to clinical trials. In the new CSO operating model, the Sr Director provides governance and oversight of the Clinical Monitoring workforce supporting European markets, including Clinical Research Associates [. .. ] effective collaboration between monitoring teams and country/ site leadership to support country performance and site delivery. Key Responsibilities Accountable for CSO countrys performance across assigned European markets, including delivery governance, risk management, and resolution of operational issues. Leads and develops people managers and country/ site leadership to ensure consistent execution, capability development, and sustainable workloads. Preserves and strengthens CCSL site engagement, sponsor oversight, and site intelligence to inform site selection and portfolio decisions. Provides oversight of monitoring delivery (CRA/ CML; FTE/ [. .. ]
Job am 03.06.2026 bei Jobleads gefunden
Senior Medical Director, Nephrology, Global Medical Affairs
• Baar, Zug
Führungs-/ Leitungspositionen
[. .. ] with clinical development and operations teams to support clinical development programs through enhanced site engagement activities and identification of center of excellence. Lead the generation of evidence [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] generation strategy, including investigator-initiated research strategy, phase 4 studies etc Partner with scientific communications and publications to support development and execution of publication plans for impactful data dissemination and medical education strategies. Identify and advance productive collaborations with external stakeholders including healthcare and patient advocacy organizations. May have direct reports. Who You Are [. .. ] known and properly addressed Ability to function independently to progress key projects with minimal direction and oversight Demonstrated ability to work effectively in teams with a commitment to cross-functional risk sharing, collaboration and learning that facilitates partnership, collective accountability and prompt, informed decision-making Maintain clinical and technical expertise through review of the scientific literature and attendance at key scientific meetings Excellent communicator, skilled at diplomacy and capable of effectively combining science and relationship building. Strong working knowledge of ex-[. .. ]
Job am 29.05.2026 bei Jobleads gefunden
Local Study Associate Director
• Wien
Führungs-/ Leitungspositionen
[. .. ] required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality. Coordinates the site selection process by identifying potential sites/ investigators, performing [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks. Ensures timely submission of application/ documents to EC/ IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/ documents for submissions to Regulatory Authority for the [. .. ] on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed. Communicates and coordinates regularly with National Coordinating Investigator/ National Lead Investigator on recruitment and other study matters, if applicable. Plans and leads National Investigator meet Ensures that all study documents are ready for final archiving and completion of local part of the e TMF. Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and [. .. ]
Job am 29.05.2026 bei Jobleads gefunden
Remote Local Study Director-Clinical Trials Lead
• Wien
Führungs-/ Leitungspositionen
[. .. ] required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality. Coordinates the site selection process by identifying potential sites/ investigators, performing [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks. Ensures timely submission of application/ documents to EC/ IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/ documents for submissions to Regulatory Authority for the [. .. ] on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed. Communicates and coordinates regularly with National Coordinating Investigator/ National Lead Investigator on recruitment and other study matters, if applicable. Plans and leads National Investigator meet Ensures that all study documents are ready for final archiving and completion of local part of the e TMF. Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and [. .. ]
Job am 27.05.2026 bei Jobleads gefunden
Clinical Research Associate
• München, Bayern
[. .. ] the sites. Proactively identifying and ensuring timely resolution to study-related issues and escalates them as appropriate. Training, supporting, and advising Investigators and site staff in study-related matters, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] including Risk Based Quality Management (RBQM) principles. Development of recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones. Document recruitment barriers and implement mitigation plans. Ensure agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (Action Items aging, SDV metrics, Data entry metrics, query aging, MV reports metrics, etc. ) Preparing and finalizing monitoring visit reports in CTMS and provide timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with Alexion SOPs. Ensuring timely collection/ uploading of essential documents into the e TMF in accordance with ICH-GCP, Alexion SOPs and local requirements. Supporting/ participating in regular QC checks of the e TMF In some countries, as required, CRAs are accountable [. .. ]
Job am 26.05.2026 bei Jobleads gefunden
Director Analytical Development (all genders) - permanent, fulltime
• Ludwigshafen am Rhein, Rheinland- Pfalz
Führungs-/ Leitungspositionen
Work-Life-Balance
[. .. ] of senior analytical strategy leads for the development and commercialization of Abb Vies late-stage biologics pipeline. Drive overall control strategy, including justifying appropriate specifications, determining critical quality [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] attributes, and risk-based comparability strategies for the biologics pipeline. Establish collaborations across the organization to ensure delivery of critical analytical BLA enabling activities. Set team strategies, manage resources, and define risk mitigation strategies. Act as the principal contact for all stakeholders and balance conflicting expectations between cross-functional areas. Communicate project strategy, [. .. ] related field with 8 years of related experience or Masters Degree with 14 years of related experience. Technical expertise in CMC analytical chemistry. Demonstrated ability to function as a principal investigator, generating original technical ideas and research or development strategies. Ability to interact well with diverse groups within the function and maintain strong working relationships with internal and external collaborators. Benefits A diverse work environment where you can have a real impact. An open corporate culture. An attractive salary. An intensive [. .. ]
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Häufig gestellte Fragen
Wieviel verdient man als Risk Investigator pro Jahr?
Als Risk Investigator verdient man zwischen EUR 50.000,- bis EUR 70.000,- im Jahr.
Wieviele offene Stellenangebote gibt es für Risk Investigator Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 46 offene Stellenanzeigen für Risk Investigator Jobs.
Wieviele Unternehmen suchen nach Bewerbern für Risk Investigator Jobs?
Aktuell suchen 12 Unternehmen nach Bewerbern für Risk Investigator Jobs.
Welche Unternehmen suchen nach Bewerbern für Risk Investigator Stellenangebote?
Aktuell suchen zum Beispiel folgende Unternehmen nach Bewerbern für Risk Investigator Stellenangebote:
- Thermo Fisher Scientific (3 Jobs)
- Alexion Pharmaceuticals (2 Jobs)
- HMNC Holding GmbH (1 Job)
- Bei Gene (1 Job)
- KBR (1 Job)
In welchen Bundesländern werden die meisten Risk Investigator Jobs angeboten?
Die meisten Stellenanzeigen für Risk Investigator Jobs werden derzeit in Bayern (8 Jobs), Nordrhein-Westfalen (7 Jobs) und Rheinland-Pfalz (5 Jobs) angeboten.
Zu welchem Berufsfeld gehören Risk Investigator Jobs?
Risk Investigator Jobs gehören zum Berufsfeld Qualitätswesen.
