Gehaltsübersicht für Cro Manager in Schweiz

The perfect candidate is someone who has done a similar position in bioanalysis previously within a pharma (preferred) or a CRO or an experienced scientist with experience with small and/or large molecules very keen to learn and with a positive attitude. Please note the preference goes to the first profile (experience in pharma/CRO). In any case, the successful candidate will have an education within biology / biochemistry. On this position, the perfect candidate has strong experience on both small AND large molecules. This is a long-term contract with a potential internal opportunity afterwards.  Tasks & Responsibilities:Lead bioanalytical strategies to generate decision-enabling bioanalytical data with skilled data interpretation to meet and answer project needsResponsible for outsourcing activities in Bioanalytics (bioanalysis of non-clinical and clinical studies); resource and time planning, coordination and administrative management of studies with CROs.Manage the development, transfer and validation of specific and sensitive bioanalytical methods required for the development compound (drug), anti-drug antibodies (ADA), soluble targets and any concomitant/interaction compound in the given project.Manage and direct analysis of samples and timeline from preclinical and clinical studies for the project at CRO labs.Participate actively in PS subteams, act as primary contact person for DMPK project leader.Act as Bioanalytical Leader when required. Interact proactively with the assay development team.Ensure full compliance with the current global and local bioanalytical guidance and GxPs.Leadership in Bioanalysis: *remain current and continually develop expertise in bioanalytical science. Contribute to scientific consortia when required; *maintain current expertise in the validation and conduct of bioanalytical assays; *guide and manage the bioanalysis at CROs and ensure that most advanced and most efficient procedures are used.Provide technical leadership in issue resolution.Review protocols and other relevant documents and guide project teams in all aspects of bioanalytical work required for the project.Review and write reports for regulatory submissions; support filings and answer any questions about bioanalytics coming from the regulatory agencies.Maintain open links with other disciplines within the department and the organization.Advise Group Head concerning all needs relating to administrative processes, technologies and equipment. Inform him of all critical issues Must haves:Minimum 3 years in a similar position focused on bioanalysis in pharma or CRO (pharma preferred) OR scientist focused on bioanalysis Excellent work experience on both large and small molecules bioanalysis Strong vendor management experience, looking after outsourced studies to external CROsDegree in biology/biochemistry  

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget Leads the regional clinical operations team (including oversight of external partners working on the regional level) and acts as point of escalation for resolution of issues within the region for the assigned study Ensures alignment of regional deliverables with overall study goals Essential Functions of the job: Regional Leadership Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study Leads external vendors involved in study delivery on a regional level Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings Leads regional operations meetings with all regional study team members Timelines, Planning and Execution Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards these Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders Provides regional input on global study plans as required Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs Ensures regional and country information in study systems and tools is entered and up to date Collaborates closely with CRAs in the region to ensure proper study execution at the sites. Reviews and signs-off monitoring reports Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC’d on a regular basis as per the study TMF QC plan Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region Manages the trial data collection process for the region, drives data entry and query resolution As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing Quality: Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads Monitors study activities in region to ensure compliance with the study protocol, SOPs, ICH/GCP and all other relevant regulations Ensures inspection readiness for study in region at any point in time throughout the study life cycle Informs Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implemented Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate Collaborates with CST members and colleagues to ensure cross-team, site learnings, and best practices are shared Leads improvements and partners with CST members to enhance the efficiency and the quality of the work performed on assigned studies Contributes to development, optimization and review of work instructions and SOPs as required Budget and Resources Works with the sourcing team to select and manage regional study vendors Manages regional study budgets Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities Identifies and manages regional team resource needs and establishes contingency plans for key resources Monitors regional resource utilization over study life cyle and liaises with functional managers as needed Supervisory Responsibilities: Provides performance feedback on team members as required Might mentor junior team members Education Required: Bachelor’s Degree in a scientific or healthcare discipline required*, Higher Degree preferred *exceptions might be made for candidates with relevant clinical operations experience Competencies: Communicating Effectively Embracing Change Driving Excellence Working in Teams Mentoring Learning Computer Skills: MS Office, Project Planning Applications Other Qualifications: 4 or more years of progressive experience in clinical research within biotech, pharma or CRO industry Proven experience in clinical research including relevant experience as team lead in clinicial functions Experience as CRA is preferred Travel: Travel might be required as per business need BeiGene Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. Currently employees are located in APAC, Americas, and Europe. BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients. For more information, see www.beigene.com. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. At BeiGene, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Bold Ingenuity Collaborative Spirit Driving ExcellenceÜber das Unternehmen:BeiGene Switzerland GmbH

Clinical Project ManagerPosted 5 Monaten ago Clinical Project Manager Are you a passionate individual with a strong background in clinical project management? Are you dreaming of a job with a real impact on patients ’lives? Do you want to work for an innovative specialist spinal implant company and play a pivotal role in advancing medical research? If yes, come to join our clinical studies team! Together we can shape the future of the healthcare. As clinical project manager you will be responsible be for managing clinical studies on Spineart products from study set up to study closure, ensuring high quality and integrity of data, and compliance with relevant SOPs, regulatory requirements, timelines and within budget. Your main responsibilities will be: Developing and managing the clinical study plan, study budget, risk identification and mitigation. Coordinating the key study document developments, including the protocol and reports. Ensuring clear and aligned communication with stakeholders, between project team members and with the clinical site investigators and teams. Overseeing all study processes including site selection and management, monitoring and data management, safety management and vendor management. Leading study project teams, ensuring clear roles and responsbilities, issues and other risks are addressed swiflty and escalated as needed. Ensuring quality control of study documents and maintains study quality metrics. Training and overseeing monitors (CRAs) and quality of their work. Conducting and maintaining an up to date literature review by study. Contributing to continuous improvement initiatives, including WI writing. Contributing to PMCF plan, PMCF report and other regulatory clinical documents The Clinical Project Manager is expected to travel approximately 25% of the time. Your profile : Minimum 3 years of recent experience in clinical study management within medical device industry, class II & III medical devices preferred, spine surgery would be an advantage. Project management skills such as use of a formal process and system for planning and tracking ongoing progress of clinical projects. CRO and other Vendor management experience. Bachelor’s degree equivalent or higher qualification within Biological Science, Pharmacy, Medicine, Nursing, or another relevant life sciences discipline. Very good communication skills including the ability to to adjust communication style, to motivate the project team and investigational sites, and the ability to present complex information to both clinical and non-clinical disciplines. An individual who takes ‘ownership’ and who is also a team player Fluency in English (working language of the team) and advanced French written and oral. Who we are : Our success also depends on our team’s value. The human being is at the centre of our concerns. We pay special attention to our recruitment to make Spineart a great place to work. For us, soft skills are as important as hard skills. What we expect from our employees is nothing short of real team spirit, mutual assistance, and self-transcendence. Our philosophy: Quality, Innovation, Simplicity Our values: Respect, Integrity, Solution oriented

Für die Verstärkung unseres Sales-Teams suchen wir per sofort eine:n:Sales Manager DACH (80-100%)In dieser strategisch wichtigen Position sind Sie die Schnittstelle zwischen unserem Unternehmen und den Vertriebspartnern in den relevanten Gebieten. Sie werden den Verkauf unserer revolutionären Reinigungslösung durch kundenorientierte und persönliche Unterstützung für unsere Geschäftspartner fördern.Sie sind ein Verkaufsprofi mit starken Analysefähigkeiten. Sie sind ein starker Kommunikator, der produktive, professionelle Beziehungen zu wichtigen Interessengruppen in seiner Region aufbauen kann.Ihr Fokus liegt auf der Steigerung und Entwicklung bestehender Kunden sowie der Generierung neuer Geschäfte durch Identifizierung, Umsetzung und Durchführung neuer Strategien.Our Swiss tech company, KEMARO AG, introduced the world's first autonomous dry cleaning robot for industrial use—the K900—five years ago. In November 2019, the first employee was hired, and since then, a little over 40 employees have been working at our Eschlikon TG site.To reinforce our sales team, we are currently seeking:Sales Manager DACH (80-100%)In this strategically crucial role, you'll be the liaison between our company and distribution partners in relevant territories. Your role will involve promoting the sale of our revolutionary cleaning solution by providing customer-oriented and personal support to our business partners.You are a sales professional with strong analytical abilities, a skilled communicator capable of fostering productive, professional relationships with key stakeholders in your region.Your focus will be on enhancing and cultivating existing clients and generating new business by identifying, implementing, and executing new strategies.Deine Aufgaben Identifizierung und Aufbau eines starken Partnernetzwerks. Beratung und Verkauf unseres Reinigungsroboters bei lokalen und wichtigen Kunden in der Region. Enge Zusammenarbeit mit unseren lokalen Partnern. Entwicklung von Marketingstrategien gemeinsam mit den Vertriebspartnern zur idealen Erschliessung neuer und bestehender Märkte. Your tasks Identifying and establishing a robust partner network. Advising and selling our cleaning robot to local and significant clients in the region. Close collaboration with our local partners. Collaborating on marketing strategies with distribution partners to effectively penetrate new and existing markets. Dein Profil Berufserfahrung im indirekten B2B-Vertrieb, idealerweise in der Industrie- oder Logistikbranche. Bevorzugt Erfahrung in der Unterstützung von Vertriebspartnern und im Management von Distributoren. Junge, schnell denkende Person mit einer hands-on Mentalität, die unternehmerische Freiheit mit einem hohen Mass an Selbstmotivation und Unabhängigkeit schätzt. Ausgezeichnete Kommunikations- und Präsentationsfähigkeiten. Unternehmerisches Denken in Verbindung mit einer hohen Affinität zu digitalen Technologien. Technisches Verständnis zur Unterstützung der Vertriebspartner und Endkunden. Sehr gute Kenntnisse in Deutsch und Englisch (schriftlich und mündlich). Erfahrung im Umgang mit CRM-Systemen und gute Kenntnisse in Microsoft 365. Wir bieten:Die Möglichkeit, Teil eines großartigen Robotik-Scale-ups zu werden Flexible Arbeitsbedingungen in unserem Büro oder in der Nähe Ihrer Kunden Attraktives Gehaltspaket (80/100 fix + Bonus + Firmenauto) Selbständigkeit und Zuverlässigkeit sind für uns genauso wichtig wie die Bereitschaft, sich kontinuierlich weiterzuentwickeln. Wenn du in einem dynamischen Umfeld arbeiten möchtest, das von Innovation und Teamzusammenarbeit geprägt ist, dann bist du bei uns genau richtig.Fühlst du dich von dieser spannenden Aufgabe angesprochen, freuen wir uns darauf, von dir zu hören.Sende deine aussagekräftigen Bewerbungsunterlagen über unsere Homepage: zu Händen von Claudia Steiert. Wir bevorzugen Direktbewerbungen.Your profile Professional experience in indirect B2B sales, preferably in the industrial or logistics sector. Preferably experienced in supporting distribution partners and managing distributors. A young, quick-thinking individual with a hands-on mentality, valuing entrepreneurial freedom coupled with high self-motivation and independence. Excellent communication and presentation skills. Entrepreneurial thinking coupled with a strong affinity for digital technologies. Technical understanding to support distribution partners and end customers. Excellent command of both written and spoken German and English. Experience with CRM systems and proficient knowledge in Microsoft 365. We offer The opportunity to be part of an amazing robotics scale-up. Flexible working conditions in our office or near your clients. Competitive salary package (80/100 fix + bonus + company car) Independence and reliability are as crucial to us as the willingness to continuously grow. If you're interested in working in a dynamic environment driven by innovation and teamwork, then you're the right fit for us.If this exciting opportunity resonates with you, we look forward to hearing from you.Please send your comprehensive application via our website: addressed to Claudia Steiert. We prefer direct applications.Jacques CouniotCRO: +41 71 747 91 11Unser Schweizer Tech-Unternehmen KEMARO AG hat vor fünf Jahren weltweit den ersten autonomen Trockenreinigungs-Roboter für den industriellen Einsatz auf den Markt gebracht – den K900. Im November 2019 wurde der erste Mitarbeitende eingestellt und in der Zwischenzeit sind etwas mehr als 40 Mitarbeitende am Standort Eschlikon TG beschäftigt.

At Julius Baer, we celebrate and value the individual qualities you bring, enabling you to be impactful, to be entrepreneurial, to be empowered, and to create value beyond wealth. Let’s shape the future of wealth management together. We are looking for senior risk professional to support our ‘Risk Governance & Assessment’ function. The Risk Governance & Assessment function maintains and further develops JB’s enterprise wide risk management framework and serves as innovative competence centre for specific and emerging risk types. By anticipating risk trends and by connecting thematic and event-driven data points world-wide, the function draws independent risk-based conclusions for the broader organisation, constructively challenges Group’s business activities, and fosters a continued strong risk awareness. Its Head reports directly to the Chief Risk Officer, a member of the Executive Board. YOUR CHALLENGE In line with JB’s Risk Management Framework, develop and operate the Third Party Risk Management governance framework governance for third-party risks Support the step-by-step implementation and global roll-out of the control framework for third-party and supply-chain risks along a pre-defined roadmap Ensure adequate oversight over the end-to-end Third Party Risk Management processes and underlying workflow tool Perform outsourcing risk assessments or ad-hoc reviews of third-party providers with critical vulnerability Actively contribute to risk reports and management presentations Build strong relationships with subject matter experts, key stakeholders as well as CRO / COO functions (Local Outsourcing Coordinators) in foreign locations YOUR PROFILE University degree or equivalent (preferably in economics | law) Broad experience in risk governance and / or non-financial risk management, with a minimum of 4-6 years within the management consulting or accounting | law firm Sound knowledge of outsourcing/third party risk regulations and industry best practices Excellent PowerPoint and Excel skills Proven ability to rapidly learn new concepts and ideas, and integrate and assimilate information of various levels of complexity and relationships across broad, multifunctional content areas Outstanding analytical, project management and conceptual skills Self-motivated, team-oriented and hands-on personality Discrete character with a critical mindset, comfortable with acting in a ‘political environment’ with Senior Management, and challenging the status quo Fluency in German and English, any further language is an advantage We are looking forward to receiving your full job application through our online application tool. Further interesting job opportunities can be found on our Career site. Is this not quite what you are looking for? Set up a job alert by creating a candidate account here. The international reference in wealth management Julius Baer is the leading Swiss wealth management group. We focus on servicing and advising sophisticated private clients from around the world, taking into account what truly matters to them – in their business and personal life, today and for future generations. Headquartered in Zurich, we are present in around 60 locations worldwide, including Dubai, Dublin, Frankfurt, Geneva, Hong Kong, London, Lugano, Luxembourg, Madrid, Mexico City, Monaco, Mumbai, Santiago de Chile, São Paulo, Shanghai, Singapore, and Tel Aviv. Why join Julius Baer? At Julius Baer our employees enjoy the benefits of a global company with the support and collegiality of a much smaller one. We are growing quickly, but we remain dedicated to maintaining our accessible structure with flat hierarchies, and approachable and supportive leaders. With offices around the world, we offer an international and stimulating work environment and the opportunity to work with a diverse team of highly motivated colleagues, bringing the best of the bank to our clients. Our core values of Care, Passion, and Excellence define the tone of how we interact with each other and our partners. Committed to your success Whether nurturing young talent with our renowned apprentice scheme, enabling ambitious university graduates to put theory into practice with our Graduate Programme, or providing first-class opportunities for experienced professionals, we look after our employees. We believe in continuous learning as a company and as individuals, which is why we put a focus on the health and well-being of our employees and offer flexible working options, a wide array of benefits, and extensive career development programmes. For more information visit www.juliusbaer.com or contact us via the Contact Form. For recruiting agents, please see the additional information here.Über das Unternehmen:CH10 - BJB Bank Julius Baer & Co. Ltd.

At Julius Baer, we celebrate and value the individual qualities you bring, enabling you to be impactful, to be entrepreneurial, to be empowered, and to create value beyond wealth. Let’s shape the future of wealth management together. We are looking for a risk professional to support our ‘Risk Governance & Assessment’ function. The mandate of the Risk Governance & Assessment function is to maintain and further develop JB’s enterprise wide risk management framework and serves as innovative competence centre for specific and emerging risk types. By anticipating risk trends and by connecting thematic and event-driven data points world-wide, the function draws independent risk-based conclusions for the broader organisation, constructively challenges Group’s business activities, and fosters a continued strong risk awareness. Its Head reports directly to the Chief Risk Officer, a member of the Executive Board. YOUR CHALLENGE Support the step-by-step implementation and global roll-out of the Group’s stress testing framework along a pre-defined roadmap Coordinate Group-wide risk assessments (Risk Landscape), business reviews, crisis management / contingency activities and other risk mitigation activities across different departments / multi levels of employee Support (ad-hoc) stress testing and scenario analysis (enterprise-wide or location specific) from general project coordination, to the aggregate / analyze stakeholder feedback towards the production of stresstesting results Maintain and support further development of JB’s risk management and risk tolerance framework, coordinate the streamlining of local governance protocols (across the Group) Maintain and keep up to date global databases, such as the Stress Testing inventory, the Third Party Register and the Outsourcing Catalogue. Compile and process quantitative and qualitative data for committee meetings and stakeholder reporting Coordinate and control GE & PE budget as well as IT Change budget for the Risk Governance & Assessment function YOUR PROFILE University degree or equivalent (preferably in economics or in any quantitative sciences), FRM or PRM is an advantage Broad experience in risk management and governance, with a minimum of 3-5 years within the management consulting or financial service industry; international experience is an advantage Proficient user in MS Office applications, especially Excel and PowerPoint Very good communicative skills; fluent in English and German Open for new challenges and willingness to learn Strong analytical, conceptual and problem solving skills Proactive and ability to work independently on own initiative Strong communication, presentation and interpersonal skills Able to work under pressure and react positively in the face of change We are looking forward to receiving your full job application through our online application tool. Further interesting job opportunities can be found on our Career site. Is this not quite what you are looking for? Set up a job alert by creating a candidate account here. The international reference in wealth management Julius Baer is the leading Swiss wealth management group. We focus on servicing and advising sophisticated private clients from around the world, taking into account what truly matters to them – in their business and personal life, today and for future generations. Headquartered in Zurich, we are present in around 60 locations worldwide, including Dubai, Dublin, Frankfurt, Geneva, Hong Kong, London, Lugano, Luxembourg, Madrid, Mexico City, Monaco, Mumbai, Santiago de Chile, São Paulo, Shanghai, Singapore, and Tel Aviv. Why join Julius Baer? At Julius Baer our employees enjoy the benefits of a global company with the support and collegiality of a much smaller one. We are growing quickly, but we remain dedicated to maintaining our accessible structure with flat hierarchies, and approachable and supportive leaders. With offices around the world, we offer an international and stimulating work environment and the opportunity to work with a diverse team of highly motivated colleagues, bringing the best of the bank to our clients. Our core values of Care, Passion, and Excellence define the tone of how we interact with each other and our partners. Committed to your success Whether nurturing young talent with our renowned apprentice scheme, enabling ambitious university graduates to put theory into practice with our Graduate Programme, or providing first-class opportunities for experienced professionals, we look after our employees. We believe in continuous learning as a company and as individuals, which is why we put a focus on the health and well-being of our employees and offer flexible working options, a wide array of benefits, and extensive career development programmes. For more information visit www.juliusbaer.com or contact us via the Contact Form. For recruiting agents, please see the additional information here.Über das Unternehmen:CH10 - BJB Bank Julius Baer & Co. Ltd.

AufgabenVerwalten aller Aspekte klinischer Studien, von der Planung bis zum Abschluss und der BerichterstattungVerfassen von klinischen Protokollen, Protokolländerungen, Einverständniserklärungen, Studienleitfäden, Fallberichtsformularen und anderen Dokumenten im Zusammenhang mit der klinischen ForschungAntragsdossiers vorbereiten und bei ECs einreichenSchnittstellenfunktion zwischen Unternehmen und CRO: Abstimmung Aktivitäten/Zeitpläne des CRO mit den behördlichen und projektbezogenen Anforderungen, Kommunikation CRO – Standorte und Dokumentation der ProjektfortschritteVerfolgen und Reporting über die Studienfortschritte einschliesslich Standortinitiierung, Probandenregistrierung, Überwachungsbesuche und relevante DokumenteEDC-System aufbauen, Verzeichnis aller Studienunterlagen führenMitwirkung bei regulatorischen Angelegenheiten hinsichtlich klinischer Aspekte bei internationalen ZulassungsanträgenSicherstellen der Übereinstimmung mit der Guten Clinischen Praxis (GCP), der Guten Herstellungspraxis (GMP), der Guten Dokumentationspraxis (GDP) und den entsprechenden behördlichen AnforderungenWir bieten Ihnen eine spannende Herausforderung im wachstumsorientierten Markt der Medizintechnik. Als engagierte und initiative Persönlichkeit können Sie prägend an der Zukunft unseres dynamischen Unternehmens mitwirken. Haben wir Ihr Interesse geweckt? Dann freuen wir uns auf Ihre vollständige Online-Bewerbung (inkl. Motivationsschreiben).ProfilMSc-Abschluss in biomedizinischen Wissenschaften oder gleichwertig mit vier Jahren Erfahrung in medizinischen, wissenschaftlichen oder klinischen Angelegenheiten oderD. mit zwei Jahren Erfahrung in der klinischen ForschungErfahrung mit der Guten Klinischen Praxis (GCP) und in BiostatistikGutes Verständnis der Geschäftsmodelle und Marktdynamiken im Bereich Medizinprodukte oder PharmaPersönlichkeit mit viel Eigenverantwortung und der Fähigkeit, Zeit, Ziele und Aufgaben selbst zu verwaltenTeamplayer mit der Bereitschaft zur funktionsübergreifenden Zusammenarbeit und Verständnis für die Perspektiven von Personen aus anderen AbteilungenReisebereitschaft im Bereich von ca. 20%Verhandlungssicher in Englisch (C1/C2), gute Kommunikationsfähigkeit in Deutsch von VorteilSehr gute Kenntnisse der MS-Office-Programme (Excel/Powerpoint)Allmendstrasse 11CH-2562 Port, SchweizFür Auskünfte steht Ihnen Herr Richard Büchi, Director Human Resources, [email protected] oder Tel. 032 332 71 00 gerne zur Verfügung.Bei fachlichen Fragen wenden Sie sich bitte an Frau Dr. Olga Grossenbacher, Director Clinical & Medical Affairs, Tel. 032 332 71 65.Hightech. Familiär. Global.Unser Ziel ist es, die Lebensqualität Millionen Menschen zu verbessern. Die Leidenschaft, Neues und Besseres zu schaffen, treibt uns Tag für Tag an, innovative Produkte und Services für die Augenheilkunde zu entwickeln. Schreiben Sie mit uns zusammen die 25-jährige Erfolgsgeschichte der Ziemer Gruppe weiter und verstärken Sie unser stetig wachsendes Team.Clinical Affairs Manager

AufgabenVerwalten aller Aspekte klinischer Studien, von der Planung bis zum Abschluss und der BerichterstattungVerfassen von klinischen Protokollen, Protokolländerungen, Einverständniserklärungen, Studienleitfäden, Fallberichtsformularen und anderen Dokumenten im Zusammenhang mit der klinischen ForschungAntragsdossiers vorbereiten und bei ECs einreichenSchnittstellenfunktion zwischen Unternehmen und CRO: Abstimmung Aktivitäten/Zeitpläne des CRO mit den behördlichen und projektbezogenen Anforderungen, Kommunikation CRO - Standorte und Dokumentation der ProjektfortschritteVerfolgen und Reporting über die Studienfortschritte einschliesslich Standortinitiierung, Probandenregistrierung, Überwachungsbesuche und relevante DokumenteEDC-System aufbauen, Verzeichnis aller Studienunterlagen führenMitwirkung bei regulatorischen Angelegenheiten hinsichtlich klinischer Aspekte bei internationalen ZulassungsanträgenSicherstellen der Übereinstimmung mit der Guten Clinischen Praxis (GCP), der Guten Herstellungspraxis (GMP), der Guten Dokumentationspraxis (GDP) und den entsprechenden behördlichen AnforderungenProfilMSc-Abschluss in biomedizinischen Wissenschaften oder gleichwertig mit vier Jahren Erfahrung in medizinischen, wissenschaftlichen oder klinischen Angelegenheiten oderD. mit zwei Jahren Erfahrung in der klinischen ForschungErfahrung mit der Guten Klinischen Praxis (GCP) und in BiostatistikGutes Verständnis der Geschäftsmodelle und Marktdynamiken im Bereich Medizinprodukte oder PharmaPersönlichkeit mit viel Eigenverantwortung und der Fähigkeit, Zeit, Ziele und Aufgaben selbst zu verwaltenTeamplayer mit der Bereitschaft zur funktionsübergreifenden Zusammenarbeit und Verständnis für die Perspektiven von Personen aus anderen AbteilungenReisebereitschaft im Bereich von ca. 20%Verhandlungssicher in Englisch (C1/C2), gute Kommunikationsfähigkeit in Deutsch von VorteilSehr gute Kenntnisse der MS-Office-Programme (Excel/Powerpoint)Wir bieten Ihnen eine spannende Herausforderung im wachstumsorientierten Markt der Medizintechnik. Als engagierte und initiative Persönlichkeit können Sie prägend an der Zukunft unseres dynamischen Unternehmens mitwirken. Haben wir Ihr Interesse geweckt? Dann freuen wir uns auf Ihre vollständige Online-Bewerbung (inkl. Motivationsschreiben).Für Auskünfte steht Ihnen Herr Richard Büchi, Director Human Resources, [email protected] oder Tel. 032 332 71 00 gerne zur Verfügung.Bei fachlichen Fragen wenden Sie sich bitte an Frau Dr. Olga Grossenbacher, Director Clinical & Medical Affairs, Tel. 032 332 71 65.Allmendstrasse 11CH-2562 Port, SchweizRichard Büchi22.01.202480 - 100%MitarbeiterFestanstellungHightech. Familiär. Global.Unser Ziel ist es, die Lebensqualität Millionen Menschen zu verbessern. Die Leidenschaft, Neues und Besseres zu schaffen, treibt uns Tag für Tag an, innovative Produkte und Services für die Augenheilkunde zu entwickeln. Schreiben Sie mit uns zusammen die 25-jährige Erfolgsgeschichte der Ziemer Gruppe weiter und verstärken Sie unser stetig wachsendes Team.Clinical Affairs Manager

Leading, planning, and delivering clinical trials in Oncology & / or Infectious disease , to ensure that studies are carried out according to protocols, SOPs, regulations and principles of GCP.Manage operational aspects of projects including budgeting, study initiation and risk managementSelect and manage external vendors, such as CROs, central laboratories ...Ensure the delivery of the clinical study according to ICH GCPProvide operational & scientific input into Protocol synopsis, Study protocol and all other study related documentsParticipate to due diligence activitiesYour profile:MSc or PhD degree in Biotechnology, Biology, Microbiology or Life Sciences related mattersMin of 8+ years' experience with proven track record of international clinical trials management (phase I to III) in the Pharmaceutical Industry, biotech & / or CRO. Previous monitoring experience requiredSound expertise in the implementation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems.Excellent experience in management of CROs, vendors and consultantsProven track record in project management skills.Fluent in English

CMC Regulatory Affairs Manager – PharmaLocationWestschweizContract typepermanent jobYour tasks:You will be responsible for leading the post-market activities of drug products development and maintenance of registration files, developing & leading the regulatory strategies within your territory, including maintenance of API DMFResponsible for preparing & reviewing regulatory submissions (CMC, module 3 especially), maintaining registration files & DMF drug products (FDA), NDA, MRP, DCP submissions, SwissMedic complianceYou will be the main point of contact for pharmacovigilance activities, maintaining policies & regulatory intelligence.Provide regulatory strategies for projects as RA representativeYour profile:MSc or PhD degree in Pharmacy, Biotechnology, Biology, Microbiology, Chemistry or related mattersMin of 4+ years' experience with proven track record in a GMP production site as CMC Regulatory Affairs Specialist / Manager (RA CMC) within the pharmaceutical sphere & / or for a biotech or CRO (required)At your ease with CTA, INDs, IMPs writing & reports. Experience with parenteral drug: an assetStrong knowledge of Regulatory Affairs with Clinical Drug Development standardsExcellent experience in handling regulatory obstacles, you are a problem solver with ability to deal with a fast-paced environmentAutonomous, curious & deeply passionate about the life sciences sphere, you have an entrepreneurial spirit and breath innovationFluent in English. French would be an asset