Clinical Research Investigator Stellenangebote


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Stellenangebot Clinical Research Investigator Job bei Oxford Global Resources Job vor 3 Tagen gefunden Oxford Global Resources

Freelance CRA- Medical Devices (German/ English)

• Frankfurt Freiberuflich
MEHR[...] would have 0. 7 to 1 FTE availability to give them support in managing sites in Germany, Switzerland and Austria. Remote opportunity + Up to 80 travel is possible. Job Description As a CRA you will be responsible for managing clinical activities at study sites conducting studies for Medical Devices. You will perform site management and monitoring activities and act as [...] and site close- out monitoring visits. Serve as primary point of contact for site questions relating to study enrollment, conduct, and close- out issues: liaise with appropriate study team members as needed. Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. Supports study start- up activities such as tracking and performing [...] safety activities such as narrative writing, managing the CEC/ DSMB, etc. Prepares and coordinates submissions to regulatory authorities. May perform other activities as assigned. Requirements Higher education degree or equivalent education, training, and experience. +2 years experience as a Clinical Research Associate Experience in monitoring medical device studies. Fluency in English and German. Understanding of clinical research processes and regulations. Certifications [...]
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Job vor 2 Tagen gefunden Country Medical Director (Senior Director) for Germany and Switzerland • München, Bayern Führungs-/ Leitungspositionen
MEHR[...] Provide leadership and direction to the medical teams in Germany and Switzerland, fostering a culture of excellence, collaboration, and continuous improvement Drive the long- acting market transformation of HIV treatment, ensuring that innovative long- acting therapies are effectively integrated into clinical practice Represent ViiV Healthcare in interactions with key stakeholders, including healthcare professionals, regulatory authorities, and patient advocacy groups Medical Affairs: [...] medical communication and education through the appropriate and compliant mechanisms Clinical Development: Collaborate with global and regional teams to support clinical trial activities, including site selection, recruitment, and study management Provide medical expertise and guidance for local clinical studies and investigator- initiated research Regulatory and Compliance: Ensure all medical activities comply with local regulations, company policies, and ethical standards Provide medical input and [...]
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Job vor 5 Tagen gefunden

Country Medical Director (Senior Director) for Germany and Switzerland

• München, Bayern Führungs-/ Leitungspositionen
MEHR[...] Provide leadership and direction to the medical teams in Germany and Switzerland, fostering a culture of excellence, collaboration, and continuous improvement Drive the long- acting market transformation of HIV treatment, ensuring that innovative long- acting therapies are effectively integrated into clinical practice Represent ViiV Healthcare in interactions with key stakeholders, including healthcare professionals, regulatory authorities, and patient advocacy groups Medical Affairs: [...] medical communication and education through the appropriate and compliant mechanisms Clinical Development: Collaborate with global and regional teams to support clinical trial activities, including site selection, recruitment, and study management Provide medical expertise and guidance for local clinical studies and investigator- initiated research Regulatory and Compliance: Ensure all medical activities comply with local regulations, company policies, and ethical standards Provide medical input and [...]
Job vor 6 Tagen gefunden Medical Director, Rheumatology • Langen, Hessen Führungs-/ Leitungspositionen Work-Life-Balance
MEHRMedical Director, Rheumatology ICON plc is a world- leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us [...] on the design, implementation, and interpretation of clinical trials. Serving as the primary medical liaison with investigators, key opinion leaders, and regulatory authorities to ensure scientific integrity and compliance with regulatory requirements. Contributing to the development of clinical study protocols, investigator brochures, and other medical and scientific documents. Reviewing and analyzing clinical trial data to support decision- making and strategic planning. [...]
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Job vor 12 Tagen gefunden

Director, Neurology European Medical Engagement Lead (MEL)

• München, Bayern Führungs-/ Leitungspositionen
MEHR[...] Lead (MEL) is to engage in meaningful peer- to- peer scientific dialog with healthcare system Regional/ International Thought Leaders (RTLs) within Europe. The Director, Neurology European Medical Engagement Lead (MEL) conducts critical activities that support advancing science, educating on evolving clinical practices, transforming science into patient care, and facilitating the development of new research collaborations (including Collaborative and Investigator led Trials and Real- World Evidence) . This role is field- based and regional in scope . It is anticipated [...]
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Job vom 22.10.2024 Medical Director, Rheumatology • Zürich Führungs-/ Leitungspositionen Work-Life-Balance
MEHRMedical Director, Rheumatology ICON plc is a world- leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us [...] on the design, implementation, and interpretation of clinical trials. Serving as the primary medical liaison with investigators, key opinion leaders, and regulatory authorities to ensure scientific integrity and compliance with regulatory requirements. Contributing to the development of clinical study protocols, investigator brochures, and other medical and scientific documents. Reviewing and analyzing clinical trial data to support decision- making and strategic planning. [...]
Job vom 22.10.2024

Medical Director, Rheumatology

• Wien Führungs-/ Leitungspositionen Work-Life-Balance
MEHRMedical Director, Rheumatology ICON plc is a world- leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us [...] on the design, implementation, and interpretation of clinical trials. Serving as the primary medical liaison with investigators, key opinion leaders, and regulatory authorities to ensure scientific integrity and compliance with regulatory requirements. Contributing to the development of clinical study protocols, investigator brochures, and other medical and scientific documents. Reviewing and analyzing clinical trial data to support decision- making and strategic planning. [...]
Job vom 11.10.2024 Lead Medical Writer (Reporting to Vice President Regulatory Affairs) • Wuppertal, Nordrhein- Westfalen Führungs-/ Leitungspositionen
MEHRYour mission As a Lead Medical Writer, you will plan, author, and organize the review process of documents pertaining to clinical studies and regulatory interactions, including (but not limited to) critical sections of marketing applications, protocols, clinical study reports, briefing documents, [...] or related field, or equivalent experience preferred. Working or academic knowledge in anti- infectives/ antiviral therapeutics is preferable. Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/ MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions. Demonstrated ability to produce clear, high- quality scientific writing in the [...] its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future. Passionate about our mission to develop anti- infective therapeutics for patients in need, a team of internationally recognized experts is driving our research and development to improve the lives of patients. We believe in a culture of trust and transparency, where feedback is [...]
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Job vom 08.10.2024

Field Medical Director

• Boudry, Neuenburg Führungs-/ Leitungspositionen
MEHR[...] disease strategy. The individual will lead the execution and implementation of the pan- CART medical affairs plan, delivering planned tactics and supporting global affiliates for Cell Therapy launches. Responsibilities include the development and approval of medical and educational materials, support clinical studies as needed as well as assisting with global and regional pan- CART strategy. Collaboration with WW Commercial, WW Clinical, WW Quality, WW Manufacturing, and Market Access colleagues is essential to establish and recommend priorities within the WW CTF strategy. The role also supports the design and planning of medical data generation, including Investigator Sponsored Research and medical affairs sponsored trials. Additionally, the individual will collaborate with senior members of the pan- CART MA Team to [...]
Job vom 08.10.2024 Field Medical Director • Boudry, Neuenburg Führungs-/ Leitungspositionen
MEHR[...] disease strategy. The individual will lead the execution and implementation of the pan- CART medical affairs plan, delivering planned tactics and supporting global affiliates for Cell Therapy launches. Responsibilities include the development and approval of medical and educational materials, support clinical studies as needed as well as assisting with global and regional pan- CART strategy. Collaboration with WW Commercial, WW Clinical, WW Quality, WW Manufacturing, and Market Access colleagues is essential to establish and recommend priorities within the WW CTF strategy. The role also supports the design and planning of medical data generation, including Investigator Sponsored Research and medical affairs sponsored trials. Additionally, the individual will collaborate with senior members of the pan- CART MA Team to [...]
Job vom 30.09.2024

Medical Science Liaison Oncology

• München, Bayern
MEHRThe Medical Science Liaison (MSL) is engaged in scientific field work and its main goal is to build partnerships and communicate with external clinical and non- clinical stakeholders (physicians, pharmacists, hospital managers, board members of scientific societies and other stakeholders) on an equal footing [...] expertise in our clients products and therapeutic areas and thus support patient care. Speaker training and support for healthcare professionals to maintain knowledge within the medical community about new therapies developed and marketed by our client. Identify and pursue potential research opportunities consistent with drug development objectives through the promotion of clinical research (e. g. non- interventional studies, registries, epidemiological projects, [...] with the Medical TA and the relevant business unit managers. Collaborate with external/ internal research colleagues and medical advisors to support clinical sites and provide feasibility and site recommendations by guidelines, internal policies and regulations. At the request of the investigator: Mediation between potential researchers and the company in the submission of IST studies (Investigator Sponsored Studies) . Managing the contracting [...]
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Stellenangebot Clinical Research Investigator Job bei Dr. Falk Pharma GmbH Job vom 05.11.2024 Dr. Falk Pharma GmbH Global Medical Science Manager (m/w/d) • Freiburg Homeoffice möglich
MEHR[...] that medical progress can only be achieved by working together. That is why we are looking for: We look for someone who is a healthcare enthusiast and who is capable of assimilating and interpreting scientific content or a wealth of clinical efficacy and safety data with adeptness in ability to translate into a logical, scientifically balanced compelling medical story for appropriate [...] or R D on creation and review of regulatory (EMA and FDA) and clinical content and documentation, related to new drugs, clinical trials, as well as medical treatments (f. ex. parts of clinical dossier module 2. 5, scientific advice requests, investigator brochures clinical parts) - with focus on epidemiology, therapeutic area or indication background, national and international guidelines and patient journey/ [...] medical- scientific publications and other literature and key external experts insights Answer and process (in close cooperation with the global safety department) internal and external medical inquiries from health care providers, patients, affiliates colleagues and/ or distribution partners Conduct extensive research on medical- related topics to ensure competent, factual, accurate and compliant communication and information on pharmaceutical- medical issues internally and [...]
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Job vom 31.10.2024

Für Freelancer- Medical Monitor- Cardiovascular/ Oncology

• München Freiberuflich
MEHR[...] insights for risk mitigation strategies. Create and update Medical Monitoring Plans. Provide medical expertise to support study teams, investigators, and sites. Offer medical input on adverse event management, including reviewing cumulative ADR/ SAE listings and other emerging safety data. Review clinical data and critical study parameters. Assist the Senior Project Leader with daily logistics of assigned study tasks, including administrative duties [...] Affiliates, and other functional departments at DS. Support Affiliates during the site selection process. Partner with the Senior Project Leader in budget control and forecasting. Engage in study- related interactions with healthcare professionals in Steering Committees, Data Safety Boards, and Investigator Meetings. Requirements You hold a graduate degree medical doctor (MD) or pharmacist with at least 6 years relevant clinical and scientific experience Strong experience Cardiovascular is required. Helpful if Oncology experience is available You have a strong understanding of regulatory environment (thorough knowledge of Clinical Research Principles, ICH- GCP, EU regulations governing clinical trials, standard regulatory and clinical practices and current regulatory issues related to clinical [...]
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