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Clinical Research Manager
Eingestellt von Elevate Direct
Gesuchte Skills: Engineering, Marketing
Projektbeschreibung
CLINICAL RESEARCH MANAGER - DIEGEM, BELGIUM - €38 - €43 PER HOUR - 12 MONTHS
Medical Devices in accordance with all applicable regulations for Medical Devices. Plan & implement a programme of monitoring for all international regulatory and post marketing clinical research studies and maintain the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants, and good/rigorous scientific practice.
JOB SPECIFICATIONS
Education Requirements:
* 1st Degree in Life Sciences, Health Sciences or related field to Biomedical Engineering or equivalent combination of education and experience.
Experience
* Experience of clinical trials monitoring in a medical company preferably with medical devices.
* Knowledge of clinical study design and management.
* Relevant experience in implementation of clinical research studies.
* Working knowledge of international regulatory requirements applicable to clinical research.
* Awareness of research ethics.
KEY TASKS
* Provide support to Clinical Trial Leader for agreed projects in the EMEA Clinical Research programme for the defined therapeutic area by monitoring and reporting on studies progress in accordance with all Corporate and Statutory requirements to agreed timescales.
* Maintain the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants and good/rigorous scientific practice.
* Keep abreast of international legislation and other requirements concerning clinical research. Prepare and submit submissions for the approval of clinical investigations to regulatory authorities and ethics committees.
* Keep abreast of developments in clinical research and the clinical literature in therapeutic areas of responsibility.
* Assist in the preparation of consent documentation where required for the proper scientific evaluation of new or existing products in accordance with all ethical and regulatory requirements for Medical Devices in respect of applicable European and International Medical Devices Regulations.
* Monitor defined clinical studies in accordance with Good Clinical Practice requirements and provide regular feedback to company personnel on the progress of trials.
*Administer the inventory of Investigational Products and control the issue of investigational products to approved sites where necessary.
* Participate in project teams and build relationships with investigators, regulatory bodies and appropriate company personnel as required regarding clinical research issues, working as directed by Clinical Trial Leader & monitoring team.
* Maintain compliance with Company SOPs.
* Maintain a high standard of housekeeping and filing accuracy.
Additional information about the process
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.
Medical Devices in accordance with all applicable regulations for Medical Devices. Plan & implement a programme of monitoring for all international regulatory and post marketing clinical research studies and maintain the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants, and good/rigorous scientific practice.
JOB SPECIFICATIONS
Education Requirements:
* 1st Degree in Life Sciences, Health Sciences or related field to Biomedical Engineering or equivalent combination of education and experience.
Experience
* Experience of clinical trials monitoring in a medical company preferably with medical devices.
* Knowledge of clinical study design and management.
* Relevant experience in implementation of clinical research studies.
* Working knowledge of international regulatory requirements applicable to clinical research.
* Awareness of research ethics.
KEY TASKS
* Provide support to Clinical Trial Leader for agreed projects in the EMEA Clinical Research programme for the defined therapeutic area by monitoring and reporting on studies progress in accordance with all Corporate and Statutory requirements to agreed timescales.
* Maintain the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants and good/rigorous scientific practice.
* Keep abreast of international legislation and other requirements concerning clinical research. Prepare and submit submissions for the approval of clinical investigations to regulatory authorities and ethics committees.
* Keep abreast of developments in clinical research and the clinical literature in therapeutic areas of responsibility.
* Assist in the preparation of consent documentation where required for the proper scientific evaluation of new or existing products in accordance with all ethical and regulatory requirements for Medical Devices in respect of applicable European and International Medical Devices Regulations.
* Monitor defined clinical studies in accordance with Good Clinical Practice requirements and provide regular feedback to company personnel on the progress of trials.
*Administer the inventory of Investigational Products and control the issue of investigational products to approved sites where necessary.
* Participate in project teams and build relationships with investigators, regulatory bodies and appropriate company personnel as required regarding clinical research issues, working as directed by Clinical Trial Leader & monitoring team.
* Maintain compliance with Company SOPs.
* Maintain a high standard of housekeeping and filing accuracy.
Additional information about the process
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Marketing/Vertrieb, Ingenieurwesen/Technik