Serving as the primary contact within the customer for trial progress and governance. Developing study management plans and further documents for complex phase I and phase II trials (including authoring trial protocol and protocol synopsis, ICF, integrated Quality plan, etc.).
. • 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.
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.
Du übernimmst die operative Verantwortung für den Bereich Clinical Trials in direkter Berichtslinie an die Geschäftsführung.Du planst und führst klinische Studien durch, definierst die Zeitleisten und verantwortest das Budget.Du bist federführend für die Auswahl und Steuerung externer Dienstleister inklusive der Verhandlung von Projekt- und Studienbudgets verantwortlich.Du führst ein hochmotiviertes Team von insgesamt 25 Mitarbeitern (ca. 10 Direct Reports) im Bereich Clinical Operations disziplinarisch und entwickelst diese weiter.Du verantwortest und optimierst Prozesse im Bereich Clinical Trials, wie z.B. die Studienrekrutierung sowie das Organisationszielbild stetig weiter.
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.
Du erstellst, aktualisierst und prüfst klinische Bewertungen (Clinical Evaluations) gemäß MDR, MDCG-Leitlinien und internationalen Standards – in englischer Sprache.Du führst Literaturrecherchen durch, analysierst klinische Daten und bewertest wissenschaftliche Evidenz.Du entwickelst und verfasst PMCF- und PMS-Pläne sowie Berichte (inkl. PSURs).Du unterstützt klinische Strategien in Zulassungs- und Entwicklungsprojekten.Du bist in Risikomanagementprozesse eingebunden.Du gestaltest aktiv mit: Vorlagen, SOPs und Arbeitsanweisungen entwickelst Du eigenverantwortlich weiter.Du kommunizierst mit Behörden, Fachkreisen und internationalen Partnern.Ausbildung/ Studium: Du bringst ein abgeschlossenes Masterstudium in Medizin, Naturwissenschaften, Medizintechnik oder einem vergleichbaren Bereich mit.Fachwissen:Erste Erfahrung mit wissenschaftlichem Arbeiten, idealerweise mit Fokus auf Medical Writing, klinische Datenanalyse oder klinische Bewertung.Kenntnisse relevanter Regularien (MDR, ISO 14155, MDCG) sind ein Plus.Idealerweise bringst Du Produktkenntnisse in der Endoprothetik mit.Soft-Skills: Du arbeitest strukturiert, bist analytisch starkDu bist kommunikationsstark und ein echter TeamplayerSprachkenntnisse: Du sprichst und schreibst Deutsch und Englisch mindestens auf C1-Niveau.Unsere Stellenausschreibung gibt Dir einen Einblick in die Anforderungen der Position.
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.
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, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
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.
Responsible for the inclusion of Cardiovascular elements into proposals.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, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.Support preparation of customer and bid defense meetings, e.g. training and preparation of the assigned project team; provide specific content; ensure presentation focus and content effectively conveys Cardiovascular strategy.
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.
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.
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 strategic and therapeutic area guidance for clinical development plans in compliance with applicable regulatory, medical, and ethics guidelines. Ensure high-quality, data-driven deliverables that meet the highest standards of medical, ethical, and scientific integrity and conduct.
Balance use of external research and data with IQVIA’s internal data sources.Guide and mentor assigned Project Leader so that they can confidently present the project strategy to the client and the internal stakeholders.Actively support Sales in the preparation and conduct of customer and bid defense meetings e.g. training and preparation of the assigned project team.Attend, present and lead or bid defense meeting or customer meeting, as requiredIdentify any quality issues within the study and provide coaching on resolution of issues, including implementation of corrective and preventative action plans and escalation.Ensure project/program budget(s) meet financial and company goals, including Gross New Business. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Deep and current knowledge of the scientific, clinical operations, real world, regulatory, operational, commercial and competitive landscape in applicable therapeutic area.
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!
Develop and execute strategies to enhance advocacy and engagement among key eye-care providers, ensuring alignment with overall brand and commercial objectivesDesign and implement training approaches that enable local SSCs to identify, recruit, and cultivate strong relationships with KOLs within their regionsBuild and sustain robust relationships with the ophthalmic medical community- including academic institutions and specialized physicians-using a scientific, needs-based approach to deliver targeted solutionsConduct an annual needs assessment for KOL activities and create regional execution plans in collaboration with key internal stakeholders; provide leadership with ongoing progress updates on the impact of regional KOL initiativesContribute to the development of advanced communication programs to ensure KOLs receive timely updates on company developments, products, and clinical dataOversee and maintain the regional KOL database to ensure accuracy, completeness, and effective engagement tracking through honoraria; annually update contracted HCP biographies and publications, ensuring all documentation remains current; deliver periodic utilization and budget reports to the Global KOL DirectorAct as the primary liaison with the legal department to develop and manage KOL contracts and service agreements in full compliance with regulatory requirements; coordinate and process all onboarding documentationPlan, coordinate, and execute approved regional advisory boards in support of KOL Management and the Chief Medical OfficerRepresent the company at regional medical congresses and scientific meetings, supporting KOL strategy execution and identifying emerging key influencersServe as an internal expert on disease state and product knowledge, empowering internal and field teams to better understand clinical needs, strengthen KOL loyalty, and foster broader adoption within the ophthalmic communityCollaborate closely with internal teams-including Marketing, R&D, and Professional Education—to address cross-functional KOL needs and ensure smooth coordination of activities Solid direct experience working with Key Opinion Leaders, ideally within the ophthalmology sector Exceptional communication and interpersonal skills, with the ability to build trust-based relationships across diverse stakeholder groupsFull professional proficiency in English, both spoken and writtenStrong business acumen and a demonstrated ability to effectively manage timelines, processes, and procedural workflowsExperience with product launches, advisory boards, and post-approval studies is highly advantageousRelevant academic background required (e.g., life sciences, healthcare, business, or a related field) A very renowned companyOther Locations: Oberkochen/Jena/Berlin Ihr Kontakt Referenznummer 865508/1 Kontakt aufnehmen Telefon:+ 49 621 1788-4297 E-Mail: positionen@hays.de Anstellungsart Anstellung bei der Hays Professional Solutions GmbH
Develop and execute strategies to enhance advocacy and engagement among key eye-care providers, ensuring alignment with overall brand and commercial objectives Design and implement training approaches that enable local SSCs to identify, recruit, and cultivate strong relationships with KOLs within their regions Build and sustain robust relationships with the ophthalmic medical community- including academic institutions and specialized physicians-using a scientific, needs-based approach to deliver targeted solutions Conduct an annual needs assessment for KOL activities and create regional execution plans in collaboration with key internal stakeholders; provide leadership with ongoing progress updates on the impact of regional KOL initiatives Contribute to the development of advanced communication programs to ensure KOLs receive timely updates on company developments, products, and clinical data Oversee and maintain the regional KOL database to ensure accuracy, completeness, and effective engagement tracking through honoraria; annually update contracted HCP biographies and publications, ensuring all documentation remains current; deliver periodic utilization and budget reports to the Global KOL Director Act as the primary liaison with the legal department to develop and manage KOL contracts and service agreements in full compliance with regulatory requirements; coordinate and process all onboarding documentation Plan, coordinate, and execute approved regional advisory boards in support of KOL Management and the Chief Medical Officer Represent the company at regional medical congresses and scientific meetings, supporting KOL strategy execution and identifying emerging key influencers Serve as an internal expert on disease state and product knowledge, empowering internal and field teams to better understand clinical needs, strengthen KOL loyalty, and foster broader adoption within the ophthalmic community Collaborate closely with internal teams-including Marketing, R&D, and Professional Education—to address cross-functional KOL needs and ensure smooth coordination of activities Solid direct experience working with Key Opinion Leaders, ideally within the ophthalmology sector Exceptional communication and interpersonal skills, with the ability to build trust-based relationships across diverse stakeholder groups Full professional proficiency in English, both spoken and written Strong business acumen and a demonstrated ability to effectively manage timelines, processes, and procedural workflows Experience with product launches, advisory boards, and post-approval studies is highly advantageous Relevant academic background required (e.g., life sciences, healthcare, business, or a related field) A very renowned company Other Locations: Oberkochen/Jena/Berlin Ihr Kontakt Referenznummer 865508/1 Kontakt aufnehmen Telefon:+ 49 621 1788-4297 E-Mail: positionen@hays.de Anstellungsart Anstellung bei der Hays Professional Solutions GmbH
Key Responsibilities: To develop a satisfactory level of clinical competence in ART skills e.g. plan and co-ordinate treatment cycles, to undertake specific investigations such as endocrine profiles. To assist in the management, and support of sub-fertile couples before, during and after treatment cycles, developing a therapeutic environment to meet the individual needs of the couples.
Key Responsibilities: To develop a satisfactory level of clinical competence in ART skills e.g. plan and co-ordinate treatment cycles, to undertake specific investigations such as endocrine profiles. To assist in the management, and support of sub-fertile couples before, during and after treatment cycles, developing a therapeutic environment to meet the individual needs of the couples.
Key Responsibilities: To develop a satisfactory level of clinical competence in ART skills e.g. plan and co-ordinate treatment cycles, to undertake specific investigations such as endocrine profiles. To assist in the management, and support of sub-fertile couples before, during and after treatment cycles, developing a therapeutic environment to meet the individual needs of the couples.
Als Product Manager Medical Cannabis übernimmst Du die Verantwortung für die Betreuung und Weiterentwicklung unseres Produktportfolios – von Cannabis-Vollextrakten bis zur Markteinführung unseres neuen Fertigarzneimittels VER‑01. Dabei gestaltest Du unsere Marke aktiv mit, planst und koordinierst Marketing‑, Schulungs‑ und Kommunikationsmaßnahmen und sorgst dafür, dass wissenschaftliche Evidenz auf prägnante Markenkommunikation trifft.
Contribute to the development and implementation of annual business plans and clinic goals. Support cost-control initiatives via efficient rota management, overtime/on-call/TOIL, and resource utilisation (with financial accountability resting with the GM).