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.
. • 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.
Payroll Manager (m/w/d) Ihre Aufgaben: Full responsibility for the accurate and timely end-to-end payroll processing for a German legal entity Ensure compliance with all applicable German labor laws, tax regulations, and social security requirements Close collaboration with HR and Finance regarding salary adjustments, benefits, and other compensation-related changes Manage and oversee external payroll service providers, ensuring quality and performance standards Coordinate with external pension and benefits providers, including data exchange, reporting, and audit support Prepare regular and ad-hoc payroll reports for internal and external stakeholders Support internal and external audits, including reconciliations and resolution of discrepancies Review quarterly tax filings and perform payroll-related reconciliations Identify and implement process improvements and automation initiatives to enhance efficiency and accuracy Act as the primary point of contact for employees regarding payroll-related inquiries Provide guidance on time tracking and approval workflows within the Workforce Management system Ensure proper documentation and maintenance of payroll records Ihr Profil: Bachelor’s degree in Accounting, Finance, Business Administration, or a comparable qualification Minimum of 5 years’ experience in payroll administration, with a strong focus on German payroll In-depth knowledge of German payroll regulations, tax law, and compliance requirements Experience working with external payroll vendors Strong proficiency in payroll systems and HRIS/time tracking tools Analytical mindset with strong attention to detail and accuracy Highly organized, reliable, and able to handle sensitive information with discretion Fluent in German and English Preferred Qualifications Experience with equity-based compensation, bonus schemes, or international assignments Familiarity with internal control frameworks and compliance requirements (e.g., SOX) Advanced Excel skills and experience in payroll data reporting and audit preparation Strong communication skills with the ability to work both independently and collaboratively Ability to manage a diverse workload in a deadline-driven environment Ihre Vorteile: You can look forward to a secure, future-oriented position with performance-based compensation and attractive working conditions.
Payroll Manager (m/w/d) Ihre Aufgaben: Full responsibility for the accurate and timely end-to-end payroll processing for a German legal entity Ensure compliance with all applicable German labor laws, tax regulations, and social security requirements Close collaboration with HR and Finance regarding salary adjustments, benefits, and other compensation-related changes Manage and oversee external payroll service providers, ensuring quality and performance standards Coordinate with external pension and benefits providers, including data exchange, reporting, and audit support Prepare regular and ad-hoc payroll reports for internal and external stakeholders Support internal and external audits, including reconciliations and resolution of discrepancies Review quarterly tax filings and perform payroll-related reconciliations Identify and implement process improvements and automation initiatives to enhance efficiency and accuracy Act as the primary point of contact for employees regarding payroll-related inquiries Provide guidance on time tracking and approval workflows within the Workforce Management system Ensure proper documentation and maintenance of payroll records Ihr Profil: Bachelor’s degree in Accounting, Finance, Business Administration, or a comparable qualification Minimum of 5 years’ experience in payroll administration, with a strong focus on German payroll In-depth knowledge of German payroll regulations, tax law, and compliance requirements Experience working with external payroll vendors Strong proficiency in payroll systems and HRIS/time tracking tools Analytical mindset with strong attention to detail and accuracy Highly organized, reliable, and able to handle sensitive information with discretion Fluent in German and English Preferred Qualifications Experience with equity-based compensation, bonus schemes, or international assignments Familiarity with internal control frameworks and compliance requirements (e.g., SOX) Advanced Excel skills and experience in payroll data reporting and audit preparation Strong communication skills with the ability to work both independently and collaboratively Ability to manage a diverse workload in a deadline-driven environment Ihre Vorteile: You can look forward to a secure, future-oriented position with performance-based compensation and attractive working conditions.
Quality Support Specialist (m/w/d) Wareneingang / Distribution HIER WERDEN SIE ARBEITEN: Unser Mandant ist ein international tätiger Logistikdienstleister mit Hauptsitz in Belgien mit langjähriger Tradition und familiären Werten.
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.
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.
To grow the business and to help Zeelandia’s customers to grow their business, the Marketing and R&D teams of the Zeelandia Group are working closely together in one department. This supports collaboration, also trainings are provided to the operational companies (OpCo’s) in the countries in order to lead new product development and to enhance innovation to fuel growth.
Stellenbeschreibung DEKRA Arbeit GmbH is seeking a dedicated and reliable Project Assistant (m/f/d) – Finance (AMLA) for a financial authority in Frankfurt am Main. In this role, you will support both the Governance team and IT Project Managers with administrative tasks, coordination of meetings and stakeholders, as well as project-related activities, ensuring timely execution and compliance with internal procedures.
Willis Towers Watson GmbH sucht in Frankfurt eine/n Sales Operations und Key Account Management Support (m/w/d) (ID-Nummer: 13685040)
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.
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.
IHR AUFGABENGEBIET Aktive Unterstützung der Partner bei Verkaufsprozessen: Begleitung bei Kundengesprächen und Sales-Pitches Bereitstellung von Verkaufsmaterialien und Produktinformationen Coaching und Training der Partnerteams in Verkaufstechniken und Produktkenntnissen Umsatzgenerierung und -Verantwortung: Festlegung und Erreichung von Monats- und Quartalszielen pro Partner Budget- und Ergebnisverantwortung für definierte Partner Betreuung bestehender Partnerschaften: Regelmäßige Kommunikation und Meetings mit Partnern Sicherstellung einer optimalen Zusammenarbeit zwischen Partnern und internen Support-Teams Unterstützung bei der Organisation und Durchführung von Events oder Kampagnen Strategische Aufgaben: Erstellung von Business- und Marketingplänen Analyse von Markttrends und Wettbewerbssituationen Identifikation von Wachstumschancen innerhalb des Partnerportfolios IHRE KENNTNISSE Sie verfügen über fundierte Kenntnisse in der IT-Branche und sind mit den Themen Business-Software und digitale Transformation bestens vertraut.
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) .
. ------ Deine Aufgaben Administration von Office365 (Teams, Sharepoint, OneDrive und Powerplattform) Erstellung von innovativen Lösungen auf Basis Office365 anhand unserer internen Kundenanforderungen Strategische Weiterentwicklung unserer Office365 Plattform Koordination und Zusammenarbeit mit unseren Partnern Mitarbeit in Projekten und Unterstützung der Fachbereiche Training und Beratung unserer Mitarbeiter 3rd Level Support ------ Deine Qualifikation Erfolgreich abgeschlossenes Studium Wirtschaftsinformatik, Informatik oder sehr gut abgeschlossene IT-nahe Berufsausbildung Strukturiertes, selbstständiges Arbeiten Berufserfahrung mit Office 365 wünschenswert Powershell- Kenntnisse von Vorteil Gute Kommunikations- und Präsentationsfähigkeiten Freude in einem innovativen Umfeld und im Team zu arbeiten ------ Das bieten wir Dir Selbstständige und eigenverantwortliche Alltagsgestaltung Professionelle und umfangreiche Einarbeitung Teil eines großartigen Teams mit echtem Teamspirit Offene Teamstrukturen in einem kollegialen Arbeitsumfeld Unbefristete Anstellung in einem sicheren traditionsreichen Familienunternehmen Dienstsitz in Reutlingen Moderne Büros, hauseigenes Bistro, kostenlose Getränke, ausreichend Parkplätze ------
Beraterpersönlichkeit: Strukturiert, lösungsorientiert, eigenverantwortlich und auch unter Zeitdruck ein immer souveränes und professionelles Auftreten Du hast den Kundenwunsch immer im Blick und bist mit dem Herzen bei der Sache ------ Das bieten wir Dir Interessante Aufgaben, spannende Bauprojekte, und die Mitarbeit in dynamischen Teams Ein innovatives, dynamisches Arbeitsumfeld und die Möglichkeiten, eigene Ideen mit einzubringen und von Beginn an Verantwortung zu übernehmen Kontinuierliche, persönliche und fachliche Weiterentwicklung durch unsere Führungsakademie Langfristiger Aufbau eines Lean-Teams für bundesweiten Support Firmenwagen, der auch zur privaten Nutzung zur Verfügung steht Mitarbeiter-Events wie Sommer- und Weihnachtsfeiern ------
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.
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.
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.
Karriere: Wir belohnen Erfolg mit großartigen Incentives und haben ein Auge auf Deine Entwicklung: Viele unserer Führungskräfte kommen aus den eigenen Reihe Deine Aufgaben, unsere Unterstützung: Support zum Start: Die ersten Wochen unterstützen wir Dich mit einem gezielten Online-Ausbildungsprogramm in unserer hauseigenen Academy.
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.
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.
Außerdem verantworten Sie das Monitoring und Reporting des Deployment-Fortschritts am Standort und nehmen regelmäßig an den Project Support Community Meetings teil. Ihr Profil: Must-haves Abgeschlossenes Studium im Bereich Life Sciences, Pharmazie, Biologie, Chemie oder Regulatory Affairs – oder vergleichbare Qualifikation mit Berufserfahrung; auch als Regulatory Affairs Specialist (m/w/d), Regulatory Operations Specialist (m/w/d) oder RIM Data Specialist (m/w/d) sind Sie willkommen.
Außerdem verantworten Sie das Monitoring und Reporting des Deployment-Fortschritts am Standort und nehmen regelmäßig an den Project Support Community Meetings teil. Ihr Profil: Must-haves Abgeschlossenes Studium im Bereich Life Sciences, Pharmazie, Biologie, Chemie oder Regulatory Affairs – oder vergleichbare Qualifikation mit Berufserfahrung; auch als Regulatory Affairs Specialist (m/w/d), Regulatory Operations Specialist (m/w/d) oder RIM Data Specialist (m/w/d) sind Sie willkommen.
IHRE AUFGABEN UND VERANTWORTUNGSBEREICHE: Projektmanagement eines anspruchsvollen und bekannten Großprojekts Projektleitungsfunktion gegenüber und Regelabstimmung mit dem Kunden Wöchentliche interne Projektbesprechungen mit dem Team sowie Durchführung der ARGE-Sitzungen Mitarbeiterführung, Ressourcenplanung und Recruiting, fachlicher und menschlicher Ansprechpartner und Support für das Projektteam Erstellung von Monatsberichten und Durchsprache mit den Beteiligten Steuerung von Terminen, Kosten und Qualitäten, Identifizierung und Lösung von Risiken für den Ablauf Mitverantwortung bei der technischen, wirtschaftlichen und organisatorischen Bauberatung Kommunikation, Information und Abstimmung mit allen Projektbeteiligten im gesamten Projektverlauf, Entscheidungen über die strategische Vorgehensweise IHRE QUALIFIKATION: Abgeschlossenes Studium der Architektur, Bauingenieurwesen oder eine vergleichbare Qualifikation Mehrjährige Berufserfahrung im Projektmanagement von großen Bauprojekten Mehrjährige Führungserfahrung in Projektteams Sehr gute Kenntnisse in HOAI, AHO, VOB und VgV sowie gute Kenntnisse im Umgang mit MS Project Gute Englischkenntnisse in Wort und Schrift Kompetenz in der Entwicklung innovativer Lösungen für technische und ökonomische Aufgabenstellungen sowie ein überzeugendes Auftreten UNSER KUNDE BIETET: Eigene Akademie mit vielfältigen Angeboten Mobiles Arbeiten (positionsabhängig), unterschiedliche Teilzeitmodelle, Kinderbetreuungszuschuss Firmenrad-Leasing und ÖPNV-Zuschuss Gesundheitsbonus für sportlich Aktive, moderne und ergonomische Arbeitsplätze Zugang zum Corporate-Benefits-Portal, kostenlose Getränke und frisches Obst Mitarbeiterempfehlungs-Programm, Networking-Events, Teamworkshops IHRE BERATER: Thorsten Augusti Tel: +49 228 25 90 4 - 0 Mail: t.augusti@fmsgmbh.de Andreas Hodapp-Schneider Tel: +49 228 25 90 4 - 17 Mail: a.hodapp@fmsgmbh.de Bitte geben Sie bei Ihrer Bewerbung per Mail die Kennziffer 20235 an!
This position is responsible for managing the reception area and providing administrative support to the Workplace Management team. The Facilities Assistant/Receptionist will handle a variety of tasks related to workplace operations to ensure a smooth and productive work environment.
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.