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.
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.
Provide scientific, clinical, and operational advice to internal stakeholders developing proposals: this may include, but is not limited to, providing the strategy to protocol design/clinical development plan, mining data to address important clinical questions relevant to the study, reviewing the protocol for scientific/regulatory soundness and feasibility, logistics challenges, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
Acting as a strategic partner, you will optimize site experience and performance while fostering strong relationships and sharing medical and scientific information with healthcare providers and caregivers. 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.
You will provide internal consulting services, including specifications and user needs analysis for complex project or client requirements. 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!
Risk-Based Quality Management: Defines medically critical data/processes and associated risks.Contributes to Integrated Quality and Risk Management Plan (IQRMP).Participates in risk discussions during trial conduct. Clinical Quality Monitoring: Co-authors Clinical Quality Monitoring Plan (CQMP).Aligns CQMP with IQRMP-identified risks and mitigations.
. • 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.
Statistical Analysis & Methodology Independently author Statistical Analysis Plans (SAPs), including drafting in collaboration with cross‑functional partners, pharma statisticians, or from finalized protocols.Implement non‑standard or advanced statistical methodologies, such as:Complex time‑to‑event analysesMMRM and other longitudinal modelsMethods aligned with estimands, including deep understanding of competing policies, assumptions, and analytical implicationsPerform or oversee statistical analyses, ensuring scientific rigor and regulatory compliance.Conduct sample size calculations using SAS or R, and justify design assumptions when engaging with clinical leadership.
YOUR ROLE Responsible for growing the long-term value and performance of the entire bread category by developing a category strategy to analyze and optimize the profitability of the product line Managing and coaching 2 Product Leaders Supporting OpCo’s in making strategic product choices, acting as an internal advisor and decision driver for the category Maintaining the standard portfolio, developing and maintaining strategic brands and concepts across multiple countries Leading innovations projects from business case to market introduction by customers, end-to-end (E2E) Building solid bridges between the group, organization and OpCo’s and co-create with cross functional colleagues Identifying additional markets to launch and defining with OpCo’s, M&A and strategic partnership options to address adjacent growth opportunities and complete the category portfolio Collaborating intensively with the other Global Category Managers, Product Leaders, the Commercial Development Manager and the OpCo’s Member of the Marketing/R&D Management Team and reporting to the Group Marketing/R&D Director YOUR PROFILE BSc/MSc degree in Marketing, Business Administration, Food Science & Technology or similar Relevant experience in international B2B marketing, category management in senior management roles, preferably in the international food ingredients industry Capable of understanding the technical aspects of products like functional ingredients such as enzymes, emulsifiers or other raw materials Strong project management skills by leading and participating in cross-functional teams and by building bridges between global and local teams Good understanding about trends, market and customer requirements and able to translate these into plans and actions Comfortable working in an international matrix organisation with different stakeholders, markets and cultures and willingness to travel in Europe; Zeelandia offers the possibility for hybrid working in combination with working in the office in Zierikzee or any other Zeelandia office or plant in Europe Excellent communication and presentation skills in English Personal skills: leadership, well organised, analytically strong, drive for innovation, setting priorities, convincing and taking decisions priorities, convincing and taking decisions CONTACT If you are interested in this position, please contact Jakob Jan Verbraak from our IFR-A partner DUPP, telephone: +31 317-468686 / +31 6-51820349 or apply through their website www.dupp.nl or e-mail your written application to info@dupp.nl.
Ausbildung und Förderung der Mitarbeitenden in Abstimmung mit dem Bereich Human Ressources Sicherstellung der Kundenzufriedenheit Sie berichten an die Geschäftsführung und tragen im Führungskreis des Unternehmens gemeinsam mit Ihren Kollegen zur erfolgreichen Entwicklung unseres Mandanten bei Dienstsitz: Raum Frankfurt /M, bundesweit möglich Einstellungsdatum: schnellst möglich Gehalt: nach Vereinbarung Anforderungen Mehrjährige Erfahrung im Bereich der Führung von Vertriebsteams im Umfeld „Öffentliche Auftraggeber“ Belastbares Netzwerk zu Entscheidern, Planern und Beeinflussern im öffentlichen Sektor Mehrjährige Erfahrung im IT-Umfeld des öffentlichen Dienstes und ein ganzheitliches IT-Architektur-Verständnis Ausgeprägtes betriebswirtschaftliches Verständnis Ausgeprägtes Verständnis im Zusammenspiel der Themenbausteine Netzwerk, Security, IT-Management, Datacenter, Cloud und Collaboration Mehrjährige Management Erfahrung in der erfolgreichen Führung von Vertriebsteams Mehrjährige Management Erfahrung mit Umsatz- und Ergebnisverantwortung Strategische Kompetenzen in der Verkaufsplanung und Steuerung Unternehmerisch handelnde Persönlichkeit Tiefe Markt- und Branchenkenntnisse im Kontext der IT-Systemintegration Studium der Informatik oder einer verwandten Fachrichtung bzw. eine fundierte Ausbildung mit langjähriger praktischer Erfahrung im IT-Bereich Ausgeprägte Kommunikations und Entscheidungsstärke, Überzeugungskraft und Sozialkompetenz Hohe konzeptionelle, kreative und logische Fähigkeiten Ausgezeichnete Fähigkeiten im Bereich der Rhetorik, Präsentation und Moderation.
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