Job Description
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As a key member of our team, you will play a pivotal role in the success of our clinical research projects. Your primary responsibility will be to oversee the design, planning, implementation, and management of these projects, ensuring compliance with protocols and clinical objectives.
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With your extensive experience in pre-market and post-market clinical studies of medical devices, you will work closely with our interdisciplinary team to execute and close both pre-market and post-market clinical studies. This will involve developing and approving study-specific documents, tools, presentations, and processes, as well as preparing ethics submissions and study-specific documents such as protocols, patient information leaflets, informed consent forms, and case report forms.
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One of your key responsibilities will be to maintain Trial Master Files and Investigator Site Files for multiple studies, prepare and present at Investigator meetings, participate in site qualification, study initiation, and study closure process, and assist with the management of medical device tracking and accountability.
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You will also be responsible for creating and maintaining study databases, including data entry, routinely reviewing data/CRFs to ensure data integrity, accuracy, and protocol compliance. Additionally, you will track and report progress of studies to applicable internal stakeholders, including patient screening, enrollment, data collection, adverse event documentation, and reporting.
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Furthermore, you will develop study reports and provide clinical reports for regulatory submissions, perform monitoring and site visits, including preparation of site visit, data query, adverse event, and study deviation reports. You will act as a company liaison to work with clinical sites, Contract Research Organizations (CROs), Site Management Organisations (SMOs), and other vendors/consultants.
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It is essential that you maintain familiarity with all applicable regulatory requirements and relevant clinical literature, as well as compliance with ISO 13485, ISO 14155, ICH GCP, EU MDR, US 21CFR820, Declaration of Helsinki, Data Protection Act, and any other clinical study/trial regulations.
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Requirements and Qualifications
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* A Bachelor's degree in Science or related disciplines with a minimum of 4 years of experience in the medical device industry.
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* Experience in pre-market and post-market clinical studies of medical devices is essential.
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* Clinical certifications are desirable.
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* Thorough understanding and knowledge of ISO 13485, ISO 14155, ICH GCP, US 21CFR820, and EU MDR.
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* Proven track record with the ability to successfully manage projects to deadlines.
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* Strong ability to manage critical projects as part of an interdisciplinary team.
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* Excellent problem-solving and communication skills.
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* Must be self-motivated, highly organized, and detail-oriented.
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* Excellent oral and written communication skills.
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* Must be able to work as part of a cross-functional team.
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* Thrives to work in a fast-paced / entrepreneurial environment.
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Benefits
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This role offers a competitive salary, bonus, pension, healthcare, and excellent opportunity to develop your experience and career in an exciting company. Our company has recently been acquired and has developed a breakthrough single-use medical device that addresses pain points of the current treatment of the surgical tympanostomy, a procedure that drains out the excess fluid built up in the ear.
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Other Information
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This role requires a high level of organization, attention to detail, and excellent communication skills. If you are passionate about managing clinical studies for state-of-the-art implantable medical devices and thrive in a fast-paced environment, we encourage you to apply for this role.