. • Work within a complex GCP and regulatory environment and on global clinical trials with multidisciplinary, international teams and with various internal and external stakeholders including suppliers and investigational sites. • Lead and support local trial team and investigative sites in timely preparation of required trial documents, contracts, and necessary approvals. • Ensure compliance with ICH-GCP and all other relevant regulatory regulations as well as accordance with client SOPs and values. • Assure highest ethical and professional standards, patient safety, and that local component of trial is planned, conducted, and reported in line with regulatory requirements. • Set up, manage, and review operating unit trial budget to ensure appropriate level of financial oversight and timely budget updates based on trial changes. • Assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements. • Ensure appropriate trial-specific training of internal and external partners in line with Trial Training Plan. • Develop and maintain relationships with investigational sites and support CRAs in site contacts. • In collaboration with Site Monitoring Lead and CRAs, ensure: o provision of appropriate trial oversight for the trials by monitoring compliance of trial sites and team to GCP, local regulations, customer SOPs, and adherence to trial protocol. o adequate trial supply distribution to sites. o continuous and timely data entry and cleaning, and on time Data Base Lock. o collection of required documents, with timely, complete, and compliant archiving of all relevant documents for the eTMF and CTR Appendices. • Identify risks and contingencies and partner with project leader in problem solving and resolution efforts. • Report to and relate with Trial Leader to provide updates, exchange critical information and share trial conduction information, within regulatory and compliance burdens. • Participate in and actively drive organizational, quality and process improvement initiatives to commence future leading change.
Key Responsibilities Develop study-specific action plans with research sites to accelerate recruitment and support procedural training.Educate healthcare professionals and their staff on study protocols related to clinical trials.Partner with referral networks to identify potential trial participants.Maintain and analyze customer records to tailor strategies for pre-screening, screening, and enrollment.Complete internal reporting and organize group events to optimize program delivery.Address and manage objections effectively.Stay current with technical knowledge in relevant therapeutic areas.
Your responsibilities will include: Performing site selection, initiation, monitoring and close-out visits.Supporting the development of a subject recruitment plan.Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.Collaborating with experts at study sites and with client representatives.Depending on client model there might be remote-monitoring, involvement in study start-up processes, specialization on therapeutic area (pharmaceutical product or medical devices). Mentoring of less experienced team members, support as subject matter expert for specific topics or additional tasks might be included. Qualifications: University Degree in life science or other scientific discipline or apprenticeship in the health care field.Minimum of two-four years of on-site monitoring experience alternatively an equivalent combination of education, training and experience.Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Strong written and verbal communication skills, attention to detail and ability to work in a fast pace environment.Fluency in German on at least C1 level and a good command of English.Flexibility to travel up to 40-60% of working time.Driver’s license class B.
What you can expect: Resources that promote your career growth.Leaders that support flexible work schedules.Programs to help you build your therapeutic knowledge.Dynamic work environments that expose you to new experiences.Home-office, company car/car allowance, accident insurance, pension and more.
Clinical Specialist Structural Interventions (m/w/d) - West in Frankfurt am Main Sie arbeiten als Clinical Specialist / Klinischer Support für ein renommiertes, stark wachsendes Unternehmen aus der Medizintechnik mit internationalen Niederlassungen in einem kompakten Gebiet in Westdeutschland.
Collaborating with experts at study sites and with client representatives. Mentoring of less experienced team members, support as subject matter expert for specific topics or additional tasks might be included. Qualifications: University Degree in life science or other scientific discipline or apprenticeship in the health care field.
Your responsibilities will include: Performing site selection, initiation, monitoring and close-out visits.Supporting the development of a subject recruitment plan.Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.Collaborating with experts at study sites and with client representatives.Depending on client model there might be remote-monitoring, involvement in study start-up processes, specialization on therapeutic area (pharmaceutical product or medical devices).Mentoring of less experienced team members, support as subject matter expert for specific topics or additional tasks might be included. Qualifications: University Degree in life science or other scientific discipline or apprenticeship in the health care field.Minimum of 12 month of on-site monitoring experience.Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Strong written and verbal communication skills, attention to detail and ability to work in a fast pace environment.Fluency in German on at least C1 level and a good command of English.Flexibility to travel up to 40-60% of working time.Driver’s license class B.
We are seeking a Principal Medical Writer to support full Clinical Study Report (CSR) writing for Phase 1 , protocol development, and preparation of regulatory modules (2.7.1/2.7.2) .
Protocol Deviations Management: Provides medical input on important protocol deviations (iPDs).Reviews and supports decisions on iPDs using advanced systems. Clinical Quality Communication: Proactively addresses and communicates clinical quality issues.
Maintains awareness of industry pipeline and scientific and business landscape; supports due diligence research of the CAGT landscape. Leads CAGT thought leadership at IQVIA which may include publications, presentations, and taking a leadership role in scientific activities.
Key Responsibilities Statistical Leadership & Study Support Serve as the primary statistical lead and main point of contact on the Clinical Trial Team (CTT), representing Biostatistics with confidence and professionalism.Work independently to support clinical teams, providing proactive statistical guidance throughout the study lifecycle.Lead statistical strategy discussions, including endpoint definitions, analysis methods, risk mitigation, and regulatory expectations.
Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits.Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.Deliver competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection.Contribute to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates.Ensure trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate.Ensure Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g.
Essential Functions Develop Coordinate the development of investigator grants and estimates, contracting strategies and proposal text to support the proposal development process.Develop contract language, payment language and budget templates as required as applicable to the positionUtilize and maintain contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.Ensure collaboration, including communication with sponsors, stakeholders and RSU regions and countries as applicable to the position, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.Provide specialist legal, operational and financial contracting support to the Study Teams, as applicable to site agreements to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.Ensure overall contracting efficiency and adherence to project timelines and financial goals as applicable to site agreementsReport contracting performance metrics and out of scope contracting activities as required.Work with Quality Management to ensure appropriate contract management and quality standards.
Internationale Zusammenarbeit : Arbeiten Sie an globalen Projekten und bauen Sie Beziehungen zu Kunden auf der ganzen Welt Patienten- und Datenmanagement : Unterstützen Sie bei der Erstellung von Patientenfragebögen, pflegen Sie die Datenstrukturen und übernehmen Sie die Proben-Datenverwaltung Testen und Validieren : Implementieren Sie Studienkonfigurationen und testen Sie sie anhand eines vordefinierten Testplans, um sicherzustellen, dass alles reibungslos funktioniert Qualitätssicherung : Sorgen Sie dafür, dass Prozesse und Systeme zuverlässig und effizient sind Kundenunterstützung : Bieten Sie unseren Kunden während der Testphasen Unterstützung bei Fragen und Problemen Know-how-Übertragung : Teilen Sie Ihre Erfahrungen und Kenntnisse mit neuen Kollegen, um deren Entwicklung zu fördern Systemunterstützung : Übernehmen Sie Aufgaben im Support, um unseren Kunden bei der Nutzung verschiedener Systeme zu helfen Erfolgreich abgeschlossene Ausbildung zum Medizin- / Bio- / Fach-Informatiker oder vergleichbare Ausbildung/Berufserfahrung in diesem Bereich Sehr gute Englischkenntnisse in Wort und Schrift sowie gute Deutschkenntnisse Spaß an der Arbeit mit Kunden Gute kommunikative Fähigkeiten und ein offenes Ohr für die Anliegen und Bedürfnisse der Kunden Teamfähigkeit: Sie scheuen sich nicht, Fragen zu stellen, wenn Sie einmal nicht weiterwissen, und teilen gerne Ihre Ideen und sprechen Probleme an Selbstständiges Arbeiten, das darauf ausgerichtet ist, den Kunden ein gutes Gefühl zu geben, indem Sie sich schnell, freundlich und kompetent um deren Anliegen kümmern Freude an exakter Arbeitsweise Zuschuss zur betrieblichen Altersvorsorge Flexibles Arbeitszeitmodell Gleitzeitarbeit mit festen Kernzeiten, damit Sie Ihren Tag flexibel gestalten können Ihr Kontakt Ansprechpartner Dennis Karl Referenznummer 856454/1 Kontakt aufnehmen E-Mail: dennis.karl@hays.de Anstellungsart Anstellung bei der Hays Professional Solutions GmbH
Internationale Zusammenarbeit : Arbeiten Sie an globalen Projekten und bauen Sie Beziehungen zu Kunden auf der ganzen WeltPatienten- und Datenmanagement : Unterstützen Sie bei der Erstellung von Patientenfragebögen, pflegen Sie die Datenstrukturen und übernehmen Sie die Proben-DatenverwaltungTesten und Validieren : Implementieren Sie Studienkonfigurationen und testen Sie sie anhand eines vordefinierten Testplans, um sicherzustellen, dass alles reibungslos funktioniertQualitätssicherung : Sorgen Sie dafür, dass Prozesse und Systeme zuverlässig und effizient sindKundenunterstützung : Bieten Sie unseren Kunden während der Testphasen Unterstützung bei Fragen und ProblemenKnow-how-Übertragung : Teilen Sie Ihre Erfahrungen und Kenntnisse mit neuen Kollegen, um deren Entwicklung zu fördernSystemunterstützung : Übernehmen Sie Aufgaben im Support, um unseren Kunden bei der Nutzung verschiedener Systeme zu helfen Erfolgreich abgeschlossene Ausbildung zum Medizin- / Bio- / Fach-Informatiker oder vergleichbare Ausbildung/Berufserfahrung in diesem BereichSehr gute Englischkenntnisse in Wort und Schrift sowie gute DeutschkenntnisseSpaß an der Arbeit mit KundenGute kommunikative Fähigkeiten und ein offenes Ohr für die Anliegen und Bedürfnisse der KundenTeamfähigkeit: Sie scheuen sich nicht, Fragen zu stellen, wenn Sie einmal nicht weiterwissen, und teilen gerne Ihre Ideen und sprechen Probleme anSelbstständiges Arbeiten, das darauf ausgerichtet ist, den Kunden ein gutes Gefühl zu geben, indem Sie sich schnell, freundlich und kompetent um deren Anliegen kümmernFreude an exakter Arbeitsweise Zuschuss zur betrieblichen AltersvorsorgeFlexibles ArbeitszeitmodellGleitzeitarbeit mit festen Kernzeiten, damit Sie Ihren Tag flexibel gestalten können Ihr Kontakt Ansprechpartner Dennis Karl Referenznummer 856454/1 Kontakt aufnehmen E-Mail: dennis.karl@hays.de Anstellungsart Anstellung bei der Hays Professional Solutions GmbH
Joining the Data Science & Advanced Analytics team provides the opportunity to work with large and complex data and methodologies in a fast-paced, ever-changing environment to support international customers. As a member of our team you can expect exciting international projects with interesting development perspectives.