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.
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.
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.
Wir sind das größte privatwirtschaftlich organisierte IT-Personaldienstleistungsunternehmen in Deutschland und haben für jede Karrierestufe das passende Angebot – egal ob Sie an Vakanzen in agilen KMUs oder starken DAX-Konzernen interessiert sind. Wir beherrschen die komplette IT-Klaviatur von Support bis zur Softwarearchitektur oder Digitalisierung – dank unseres umfangreichen Portfolios ist für jeden etwas dabei. So konnten wir in den vergangenen Jahrzehnten im Rahmen einer Life-Long-Partnerschaft unzählige Fach- und Führungskräfte aus der IT dabei unterstützen, die Weichen für eine erfolgreiche Karriere zu stellen.
Wir sind das größte privatwirtschaftlich organisierte IT-Personaldienstleistungsunternehmen in Deutschland und haben für jede Karrierestufe das passende Angebot – egal ob Sie an Vakanzen in agilen KMUs oder starken DAX-Konzernen interessiert sind. Wir beherrschen die komplette IT-Klaviatur von Support bis zur Softwarearchitektur oder Digitalisierung – dank unseres umfangreichen Portfolios ist für jeden etwas dabei. So konnten wir in den vergangenen Jahrzehnten im Rahmen einer Life-Long-Partnerschaft unzählige Fach- und Führungskräfte aus der IT dabei unterstützen, die Weichen für eine erfolgreiche Karriere zu stellen.
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.
Ihre Benefits Gehalt: 85.000 - 115.000 EUR pro Jahr, je nach Erfahrung und Qualifikation Flexibles Arbeiten und mobiles Arbeiten (2 Tage pro Woche remote) 33 UrlaubstageModerne Büros in zentraler Lage in Köln Internationales und dynamisches Umfeld Ihre Aufgaben Entwicklung strategischer Leitfäden für Produkteinführungen – von Marktanalyse bis Umsetzung Analyse von Markt- und Kundendaten sowie Definition von Preis- und Finanzmodellen gemäß lokalen Vorgaben Gestaltung der betrieblichen Einsatzbereitschaft inklusive Support-Strukturen und Vertriebsprozesse Optimierung der Merchant-Boarding-Journey und Koordination relevanter Prozessanpassungen Steuerung und Monitoring des gesamten Go-to-Market-Prozesses inkl.
Wir sind das größte privatwirtschaftlich organisierte IT-Personaldienstleistungsunternehmen in Deutschland und haben für jede Karrierestufe das passende Angebot – egal ob Sie an Vakanzen in agilen KMUs oder starken DAX-Konzernen interessiert sind. Wir beherrschen die komplette IT-Klaviatur von Support bis zur Softwarearchitektur oder Digitalisierung – dank unseres umfangreichen Portfolios ist für jeden etwas dabei. So konnten wir in den vergangenen Jahrzehnten im Rahmen einer Life-Long-Partnerschaft unzählige Fach- und Führungskräfte aus der IT dabei unterstützen, die Weichen für eine erfolgreiche Karriere zu stellen.
Wir sind das größte privatwirtschaftlich organisierte IT-Personaldienstleistungsunternehmen in Deutschland und haben für jede Karrierestufe das passende Angebot – egal ob Sie an Vakanzen in agilen KMUs oder starken DAX-Konzernen interessiert sind. Wir beherrschen die komplette IT-Klaviatur von Support bis zur Softwarearchitektur oder Digitalisierung – dank unseres umfangreichen Portfolios ist für jeden etwas dabei. So konnten wir in den vergangenen Jahrzehnten im Rahmen einer Life-Long-Partnerschaft unzählige Fach- und Führungskräfte aus der IT dabei unterstützen, die Weichen für eine erfolgreiche Karriere zu stellen.
Wir sind das größte privatwirtschaftlich organisierte IT-Personaldienstleistungsunternehmen in Deutschland und haben für jede Karrierestufe das passende Angebot – egal ob Sie an Vakanzen in agilen KMUs oder starken DAX-Konzernen interessiert sind. Wir beherrschen die komplette IT-Klaviatur von Support bis zur Softwarearchitektur oder Digitalisierung – dank unseres umfangreichen Portfolios ist für jeden etwas dabei. So konnten wir in den vergangenen Jahrzehnten im Rahmen einer Life-Long-Partnerschaft unzählige Fach- und Führungskräfte aus der IT dabei unterstützen, die Weichen für eine erfolgreiche Karriere zu stellen.
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.
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.
. • 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.