Support the Patient Services Manager (PSM) with administration of the monthly cryo billing reports and review of the month-end deferred revenue/income list. Managing all ICB quality queries and reporting monthly, quarterly, 6 monthly and annually as per the schedules for each ICB.
Performance Management & Commercial Alignment Monitor, analyse, and report on operational KPIs to the GM. Support the improvement of patient conversion and retention through operational excellence and service quality.
Provide ultrasound services to the highest quality Perform ultrasound examinations and compile concise and comprehensive reports Work with other team members to ensure the smooth functioning of the ultrasound service Be able to clearly explain sonography procedure to patients and making them at ease.
Experience and Knowledge: 1st level registration with NMC Educated to degree level or equivalent Minimum of 3 years managerial experience in a Healthcare setting Ability to produce clear comprehensive reports appropriate to the request of the clinician. Experience of project management activities to facilitate major service/operational changes.
Provide ultrasound services to the highest quality Perform ultrasound examinations and compile concise and comprehensive reports Work with other team members to ensure the smooth functioning of the ultrasound service Be able to clearly explain sonography procedure to patients and making them at ease.
Participates in planning and reviewing medical sections of Clinical Trial Reports. Qualifications Medical degree from an accredited and internationally recognized medical school. Typically requires a minimum of 5-7 years' experience in clinical medicine.
Ensure overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensure services are delivered per contract.Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries.Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. 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.
What We’re Looking For: Legal Qualification: 1st and 2nd German State Exam; licensed to practice law in Germany.Experience: Minimum 8 years in employment law, including 3+ years in-house.Expertise: Strong knowledge of German law; experience with Swiss, UK, or French employment law is a plus.Skills: Excellent negotiation, drafting, and stakeholder management skills.Industry Background: Pharma, biotech, or medical device experience preferred. Reporting Relationships: The role reports to the Executive Director, Assistant General Counsel, Global Employment Law Why Join Us? Competitive salary and comprehensive benefits package.Flexible hybrid working model.Leadership development programs and career growth opportunities.Wellness perks: 2 additional paid wellness days, mindfulness sessionsCareer development and training opportunitiesFind Diversity, Equality, and Inclusion at all sites and with every colleague.
Wir suchen zum nächstmöglichen Termin eine/-n HR Payroll Specialist (m/w/d) Das erwartet Sie: Betreuung der Mitarbeitenden in sozialversicherungs- und steuerrechtlichen Fragestellungen Eigenständige Durchführung der Lohn- und Gehaltsabrechnung für einen definierten Personenkreis (ca. 400 Personen) Vorbereitung und Erstellung von Vertragsunterlagen Melde- und Bescheinigungswesen und Stammdatenpflege Sicherstellung einer effizienten Schnittstelle im Kontakt zu Behörden und Krankenkassen Erstellen von Statistiken, Auswertungen und personalrelevanten Reports Das bringen Sie mit: Abgeschlossene Ausbildung als Steuerfachangestellte/r, Personalfachkauffrau/-mann, Kauffrau/-mann im Gesundheitswesen oder eine vergleichbare kaufmännische Qualifikation Mehrjährige Berufserfahrung in der Entgeltabrechnung wünschenswert Gute Kenntnisse im Arbeits-, Sozialversicherungs- und Lohnsteuerrecht sowie idealerweise im TVöD Sicherer Umgang mit MS Office sowie Erfahrung mit Dienstplan- und Abrechnungssystemen (z.
Key Responsibilities: • Perform, plan co-ordinate, and implement the following for complex studies: - The programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing - The programming of analysis datasets (derived datasets) and transfer files for internal and external clients - The programming quality control checks for the source data and to report the data issues periodically • Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies. • Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams • Fulfil project responsibilities at the level of technical team lead for single complex studies or group of studies. • Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines • Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables • Use and promote the use of established standards, SOP and best practices • Provide training and mentoring to SP team members Requirements: • Bachelor's Degree in Maths, Computer science, Statistics, or related field • 7+ years’ Statistical Programming experience within the Life Science Industry • Strong Efficacy experience • Advanced knowledge of statistics, programming and/or clinical drug development process • Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro • Language • Advanced knowledge of relevant Data Standards (such as CDISC/ADaM/SDTM) Join IQVIA to see where your skills can take you • Global exposure • Variety of therapeutic areas • Collaborative and supportive team environment • Access to cutting-edge and innovative, in-house technology • Excellent career development and progression opportunities • Work-Life Balance, with a strong focus on a positive well-being Unleash your potential!
Für unsere Bauabteilung in Nümbrecht-Gaderoth suchen wir zum nächstmöglichen Zeitpunkt einen (m/w/d) Techniker, Meister, Elektrotechniker oder Mechatroniker als Teamleiter Bauabteilung Zu den Hauptaufgaben gehören: Verantwortung für und Weiterentwicklung der Bauabteilung Führung und Entwicklung des Bauabteilungsteams, inklusive der Personalplanung und -entwicklung Steuerung und Überwachung von Bauprojekten in sämtlichen Phasen: Von der Planung bis zur Ausführung Koordination der operativen Abläufe sowie der Ressourcen (Mitarbeiter, Material, Budget) und Sicherstellung der EInhaltung interner Vorgaben (Kosten, Termine) Verantwortung für die Einhaltung relevanter gesetzlicher Vorschriften, Sicherheitsstandards und Qualitätsrichtlinien Zusammenarbeit mit internen und externen Partnern (Architekten, Ingenieuren, Dienstleistern) Erstellung von Reports und Präsentationen Identifikation und Implementierung von Optimierungsprozessen innerhalb der Bauabteilung Ihr Profil: Erfolgreich abgeschlossene Ausbildung zum Elektrotechniker/Mechatroniker (m/w/d) oder vergleichbare Ausbildungen ggf. mit Zusatzqualifikation (Techniker (m/w/d), Meister (m/w/d), o.ä.)
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) . This role requires strong writing skills and attention to detail to ensure high-quality, inspection-ready deliverables.
In addition, establishing the tone and expectation for the 3M partnership within SID across the markets of International will be first order priority. The role reports to the Executive Director, IG Portfolio Lead, Commercial Operations International. Leadership Provide strong strategic and operational marketing expertise and guidance for SID and market brand leads within International Region impacting directly the marketing functional results within the Region given the position holder directs the execution of the SID marketing strategyAbility to lead, manage, and motivate cross-functional matrix teams across international markets; fostering a culture of continuous development and improvement within the marketing communityProvide brand leadership for 3M partnership and embed integrative ways of working that enables the business to benefit from cross-functional thinking and alignment as a constantLeads the execution of the 3M operational brand plan across the international region, influencing business decisions of General Managers, which makes the position holder responsible for the SID budget & P&LOwns and drives the operational brand planning process for portfolioCo-responsible to build talent and succession pipeline for above-market Marketing positions Strategic thinking Ability to generate and leverage insights to solve complex problems and to translate into action that helps course correct portfolio/brand performance where neededAbility to launch and build new brands and adept in managing brands through their lifecycle at an above-market and in-market levelProvide strategic thought partnership to the ED IG Portfolio Lead and to the Head of International Marketing for SID growth potential realisation Execution Develop aligned customer focused brand plans and enable consistent and disciplined implementation across the international regionImplement performance tracking and management system for SID brandsProven experience in driving operational delivery within the context of marketing in an international operating environmentBuild region-wide confidence in portfolio/brand strategies and plans, and establish a culture of good practice sharingEstablish strong relationships with key external stakeholders (e.g., physicians, patient associations, and professional/medical associations and societies) Position Qualifications and Experience Requirements Education: Graduate degree or equivalent required.
Für unseren Bereich HR International in Nümbrecht-Rommelsdorf suchen wir zum nächstmöglichen Zeitpunkt zur Verstärkung unseres Teams einen (m/w/d) HR Specialist International Zu den Hauptaufgaben gehören: Sie betreuen als HR Specialist die internationalen Tochtergesellschaften sowohl in operativer als auch administrativer Sicht Neben der Aufbereitung von HR Kennzahlen erstellen Sie regelmäßige Reports und leiten daraus entsprechende Handlungsfelder ab In enger Zusammenarbeit mit Ihren lokalen Ansprechpartnern verantworten Sie die Steuerung und Einhaltung der steuer-, sozialversicherungs- und arbeitsrechtlichen Themen in Ihrem Betreuungsbereich Sie spielen eine aktive Rolle im Bereich Compensation & Benefits und stellen sicher, dass die lokalen Maßnahmen im Einklang mit der globalen Personalstrategie stehen Sie sind in das Rekrutieren neuer Mitarbeiter eingebunden und begleiten in Zusammenarbeit mit den Tochtergesellschaften den Onboardingprozess Interdisziplinäre Teamarbeit sowie die Arbeit in Projekten macht Ihnen Spaß – dabei haben Sie stets die kontinuierliche Weiterentwicklung und Optimierung von Personalprozessen im Auge Ihr Profil: Sie haben Ihr betriebswirtschaftliches Studium (idealerweise mit dem Schwerpunkt Personalmanagement) abgeschlossen oder eine vergleichbare Qualifikation mit mehrjähriger Berufserfahrung im internationalen HR Umfeld Sie kombinieren Ihre hohe Eigenmotivation mit starker Umsetzungskompetenz sowie sicherem Verhandlungsgeschick Sie können sich schnell in neue Gegebenheiten einfinden und erarbeiten eigenständig Lösungsvorschläge Sie verfügen über fundierte Kenntnisse arbeitsrechtlicher Vorschriften mit Erfahrung im internationalen Bereich bzw.
. • 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.
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. Mentoring of less experienced team members, support as subject matter expert for specific topics or additional tasks might be included.
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.
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 on study sites and client representatives. Qualifications: University Degree in life science or other scientific discipline or apprenticeship in health care.Minimum of two years of on-site monitoring experienceKnowledge 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.Good command of German and English.Flexibility to business travel up to 60% of working time.Driver’s license class B.
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).
Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for completeness.
Your responsibilities might include: Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.Collaborate with clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.Assist with periodic review of study files and completeness.Collaborate with CRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.Act as a mentor for less experienced Clinical Trial Coordinators and assist with training and onboarding of new colleagues.May serve as subject matter expert for business processes or lead Clinical Trial Coordinators study teams.May participate in departmental quality or process improvement initiatives.
Participate as lead statistician on major projects, including contributing to clinical development plans, developing/reviewing protocols, preparing/reviewing analysis plans, overseeing the conduct of analyses, preparing/reviewing integrated clinical and statistical reports, and responding to regulatory queries. Key Responsibilities: Leadership: Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company Represent sponsors at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee Participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication Participate as high level lead biostatistician on major projects, including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries and/or NDA sections Leading studies at an operational level Provide expert review and initiate methodology development work with regards to statistical standards and validation procedures Consult on operational/statistical/therapeutic area topics Knowledge Sharing: Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses Performs as subject matter expert (SME) Risk Management: Identifies risks to project delivery and/or quality, leads in a way to minimize risks Anticipates risks to avert need for study level escalations, supports lead in implementing risk mitigation actions Lock and Unblinding Process: Leads the database lock and unblinding process for the statistical team Participate on the biostatistics randomization team (drafts randomization specifications and/or perform quality control (QC) review of randomization schedules) Statistical Expertise: Provide expert statistical input into review of statistical deliverables (i.e. statistical section of a protocol, statistical analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for complex and/or integrated reports) Provide expert input into data management deliverables (i.e. database design, CRF design, validation checks and critical data) Provide expert review of ADaM reviewers guide (ADRG) and metadata Perform senior biostatistical review (SBR) Produce or perform quality control review of sample size calculations for complex studies Requirements: Masters or PhD degree in Biostatistics or a related field with relevant experience within the life-science industry Expert in a broad range of complex statistical methods that apply to Phase 2-3 clinical trials Expert in strategically collaborating with clinical and drug development expertsExperience in serving as statistical lead for regulatory submissions, including preparation of submission datasets, eCTD support, meeting with regulatory teams, and responding to regulatory queries In-depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Strong working knowledge of SAS or RExcellent knowledge of CDISC Data Standards Superb communication and collaboration skills Independent and pro-active problem solving skills IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
Demonstrated skills including project planning, workstream oversight, presentation/report development, quality control and client engagementStrong quantitative / analytical and qualitative research experience, supported by a problem solving mentality, keen eye for detail and critical thinking.
Proven success in global communications roles, ideally within pharma/biotech or regulated industries; Experience in applied science communications is highly desirable.Proven experience working in a global, highly matrixed environment, collaborating across regions and functions and influencing cross-functional stakeholders.Fluency in German and English, both written and spoken. Reporting Relationship: Role that this position reports to: Director, Communications Business Partner CSL International Roles that report to this position: none What we offer Our benefit plan offers our employees numerous choices including such options as life insurance and retirement plan Up to two additional leave days for your personal wellbeing.
To learn more please visit http://www.convatecgroup.com The Global Health Economics & Outcome Research Manager (HEOR) will be part of our Market Access and Reimbursement Centre of Excellence (COE) and report into the Director, Global Health Economics and Outcomes Research. This will be a pivotal role in supporting our Convatec Market Access capabilities our business strategy within the evolving global market access and reimbursement landscape.