Locations: Belgium and Germany. Function: The Clinical Trial Submissions Manager is responsible for the set-up and execution of clinical trial submissions to Ethical Commitees and Competent Authorities (during start-up, progress and closure). Other activities may include supporting reimbursement projects and CE-marking projects, all in compliance with the regulatory requirements throughout involved countries with reference to the relevant legislations, applicable guidelines and genae SOPs. He/She will be responsible for leading and guiding the team of regulatory associates to assure submissions are performed correct and within the expected timelines.
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Location: USA. Function: The Director Business Development takes responsibility over meeting the annual sales targets. You drive all business development activities and oversee the development and execution of the corporate strategy; including the overall management of the marketing and customer relationship activities. Activities include, but are not limited to: generating proposals, leading client meetings, active participation in conferences and exhibitions, trend and market analyses and providing leadership to the BD team.
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Locations: Belgium & Germany. Function: You take responsibility for overseeing and coordinating the start-up, progress and closure of clinical research projects. You proactively identify study related matters and set-up strategies to handle these effectively. You report to all relevant parties on a regular basis and on request; while managing the clinical research project budget in close cooperation with the Sponsor. In order to align your project team with the project objectives, time-lines and budget, you direct, guide and support them.
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Locations: Belgium, Germany, Switzerland & Japan. Function: You take responsibility for the administration and monitoring of clinical research projects according to our Standard Operating Procedures and the relevant guidelines. You analyze and evaluate clinical data, ensure compliance with protocol and overall clinical objectives; identify, select, initiate and close-out appropriate investigational sites for clinical studies. You monitor the sites in order to ensure that studies are carried out according to the applicable regulations and guidelines.
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Location: USA. Function: We are looking for experienced a Clinical Safety Manager with proven Clinical and Safety experience specifically on medical device trials to coordinate and ensure safety reporting across all studies. Manage the safety-related activities on clinical projects and minimize possible risks. Manage Clinical Safety Associates.
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Location: USA. Function: You collaborate with the European Quality Manager and take shared responsibility for the Quality Management System. You act as primary US contact for all quality related matters within the organization. You pro-actively identify and suggest improvements related to company systems & processes, and ensure that potential quality issues are identified and resolved. You will oversee and participate in inspections and audits performed by internal and external parties. You coordinate and implement continuous training strategy and material across the genae Americas offices.
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Location: Germany & Switzerland. Function: You take responsibility for the administration and monitoring of clinical research projects according to our Standard Operating Procedures and the relevant regulations. You analyze and evaluate clinical data, ensure compliance with protocol and overall clinical objectives; identify, select, initiate and close-out appropriate investigational sites for clinical studies. You monitor the sites in order to ensure that studies are carried out according to the applicable regulations and guidelines. You act as mentor for junior staff members. Regular international travel is required.
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Location: Belgium. Function: You coordinate the set-up and closure of databases used for data capture in clinical research projects. You work in a highly regulated and challenging environment. You are involved in maintaining quality of the developed products in accordance with all relevant SOPs and guidelines. You collaborate with third parties either in-house or external, and ensure that the databases are compliant to the clinical study protocol and that the overall objectives are met. You provide clear budget and status overview to both our customers and internally.
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