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.
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.
. • 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.
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.
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!
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.
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.
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.
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.