2 jobs found in lausanne, vaud

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    • lausanne, vaud
    • permanent
    Position of Medical Director (Permanent Contract) LausanneFor our client, a Swiss innovative medical device company based in Lausanne, developing and manufacturing a breakthrough imaging solution with the potential to improve patient care and cancer surgery outcome. Offering real-time ability to identify cancerous tissues and react immediately, this new visualisation modality holds the promise for a broad range of surgical and diagnostic applicationsResponsabilities :Reporting directly to the CEO, the Medical Director has the responsibility to support the Medical affairs needs. In this role, the Medical Director will partner closely with other teams to work with leadership to align and prioritize project work. - Design and develop clinical plans and protocol- Deliver and execute the clinical development plans- Develop a Medical Affairs Strategic Plan for Europe and US- Act as primary contact- Coordinate cross functional areas- Serve as Medical Expert- Document owner (or significant contributor) for Clinical Study Report- Presentation and Publication of Clinical Study Results- Provide clinical leadership and medical strategic input- Drive execution of the clinical program- Organisational Development and Compliance- Helps facilitate engagement with key subject matter experts- Develop a network of Key Opinion Leaders /investigators, interact with external stakeholders in alignment with customer needs and medical strategy.- Identify and engage international, national, and regional thought leaders- Participate in key external events- Keeps abreast of trends in health careQualifications : - Medical Degree (M.D., D.O. or equivalent) with a strong background in clinical trial management, scientific investigation and proven ability to interpret scientific and study data required.- Professional experience - 10-15 years experience in the Medical device industry in a similar position. Global exposure and expertise in US & Europe.- Expertise in strategic aspects related to marketing needs (reimbursement, regulatory pathway)- Influencing Skills - Able to establish rapport, value and respect within a team, as well as with KOLs and other influential stakeholders, externally.- Interpersonal Skills - Strong personal credibility, written and oral communication skills.- Leadership Skills : Team orientated with the confidence, maturity and integrity to lead effectively.- Problem Solving Skills – Brings a high level of intellect and curiosity to work. Able to apply mature clinical and business judgement in making decisions.- Travel : This position may require some U.S. and european travel. Ability to travel domestically and internationally- Languages - Fluent in French and English; ability to speak, read, and write. Must be able to communicate clearly and accurately. Multiple languages is a plus- Regulations knowledge - Must be able to understand legally and technically written standards, regulations, procedures, test methods so as to communicate their intent. Prefered qualifications: Expertise in oncology; breast cancer and prostate in particular.Professional relationships with an established network of oncologists and surgeons.
    Position of Medical Director (Permanent Contract) LausanneFor our client, a Swiss innovative medical device company based in Lausanne, developing and manufacturing a breakthrough imaging solution with the potential to improve patient care and cancer surgery outcome. Offering real-time ability to identify cancerous tissues and react immediately, this new visualisation modality holds the promise for a broad range of surgical and diagnostic applicationsResponsabilities :Reporting directly to the CEO, the Medical Director has the responsibility to support the Medical affairs needs. In this role, the Medical Director will partner closely with other teams to work with leadership to align and prioritize project work. - Design and develop clinical plans and protocol- Deliver and execute the clinical development plans- Develop a Medical Affairs Strategic Plan for Europe and US- Act as primary contact- Coordinate cross functional areas- Serve as Medical Expert- Document owner (or significant contributor) for Clinical Study Report- Presentation and Publication of Clinical Study Results- Provide clinical leadership and medical strategic input- Drive execution of the clinical program- Organisational Development and Compliance- Helps facilitate engagement with key subject matter experts- Develop a network of Key Opinion Leaders /investigators, interact with external stakeholders in alignment with customer needs and medical strategy.- Identify and engage international, national, and regional thought leaders- Participate in key external events- Keeps abreast of trends in health careQualifications : - Medical Degree (M.D., D.O. or equivalent) with a strong background in clinical trial management, scientific investigation and proven ability to interpret scientific and study data required.- Professional experience - 10-15 years experience in the Medical device industry in a similar position. Global exposure and expertise in US & Europe.- Expertise in strategic aspects related to marketing needs (reimbursement, regulatory pathway)- Influencing Skills - Able to establish rapport, value and respect within a team, as well as with KOLs and other influential stakeholders, externally.- Interpersonal Skills - Strong personal credibility, written and oral communication skills.- Leadership Skills : Team orientated with the confidence, maturity and integrity to lead effectively.- Problem Solving Skills – Brings a high level of intellect and curiosity to work. Able to apply mature clinical and business judgement in making decisions.- Travel : This position may require some U.S. and european travel. Ability to travel domestically and internationally- Languages - Fluent in French and English; ability to speak, read, and write. Must be able to communicate clearly and accurately. Multiple languages is a plus- Regulations knowledge - Must be able to understand legally and technically written standards, regulations, procedures, test methods so as to communicate their intent. Prefered qualifications: Expertise in oncology; breast cancer and prostate in particular.Professional relationships with an established network of oncologists and surgeons.
    • lausanne, vaud
    • temporary
    Job descriptionThe candidate's mission is to assist the Clinical Manager in setting up, conducting and closing clinical studies in cooperation with all stakeholders. You will ensure the operational coordination of national and international clinical trials in compliance with regulations, deadlines and budget.Your Responsibilities: Arranging monitoring visits at appropriate time intervals and document according to SOPs,Arranging close-out visits with sites and organizing on-site or off-site archiving; document activities as per SOPs, standard operating procedure. Follow-up and resolve any issues arising from monitoring visits,Writing visit reports and filing and collating trial documentation and reports,Ensuring all unused trial supplies are accounted,Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV),Track completed CRFs sent to data management/locked EDC forms; track issued and resolved data queries.About youYour Profile:Medical related scientific degree (Bachelor, Master, Nursing qualifications or similar degrees and/or experience),1 year experience as a CRA, Clinical Research Associate, ideally in the medical device industry,Your background has allowed you to develop your technical knowledge in onco-surgery, histopathology. You demonstrate an excellent knowledge of the regulatory and ethical environment of Clinical Studies. Knowledge of the medical devices sector and strong scientific understanding,Experience Strong working knowledge and understanding of ICH-GCP, ISO14155, MDD / MDR, Swiss laws and regulations governing clinical trials, Excellent clinical trial monitoring skills with a high level of attention to detail and strong, organizational ability, excellent interpersonal skills and a good level of communication. A sense of responsibility and a spirit of initiative will be necessary qualities. Computer skills (MS Office) and experience in eCRF system for Clinical Research, CTMS Systems, as well as eTMF Software,English and French fluent written and spoken, German and Italian is a plus,Willingness to travel as required. We offer you:An autonomous position in an international context,A position rich in contacts and interaction,A different daily routine every day,You are joining a start-up company in full development.
    Job descriptionThe candidate's mission is to assist the Clinical Manager in setting up, conducting and closing clinical studies in cooperation with all stakeholders. You will ensure the operational coordination of national and international clinical trials in compliance with regulations, deadlines and budget.Your Responsibilities: Arranging monitoring visits at appropriate time intervals and document according to SOPs,Arranging close-out visits with sites and organizing on-site or off-site archiving; document activities as per SOPs, standard operating procedure. Follow-up and resolve any issues arising from monitoring visits,Writing visit reports and filing and collating trial documentation and reports,Ensuring all unused trial supplies are accounted,Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV),Track completed CRFs sent to data management/locked EDC forms; track issued and resolved data queries.About youYour Profile:Medical related scientific degree (Bachelor, Master, Nursing qualifications or similar degrees and/or experience),1 year experience as a CRA, Clinical Research Associate, ideally in the medical device industry,Your background has allowed you to develop your technical knowledge in onco-surgery, histopathology. You demonstrate an excellent knowledge of the regulatory and ethical environment of Clinical Studies. Knowledge of the medical devices sector and strong scientific understanding,Experience Strong working knowledge and understanding of ICH-GCP, ISO14155, MDD / MDR, Swiss laws and regulations governing clinical trials, Excellent clinical trial monitoring skills with a high level of attention to detail and strong, organizational ability, excellent interpersonal skills and a good level of communication. A sense of responsibility and a spirit of initiative will be necessary qualities. Computer skills (MS Office) and experience in eCRF system for Clinical Research, CTMS Systems, as well as eTMF Software,English and French fluent written and spoken, German and Italian is a plus,Willingness to travel as required. We offer you:An autonomous position in an international context,A position rich in contacts and interaction,A different daily routine every day,You are joining a start-up company in full development.

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