Careers

genae considers people its most valuable asset. Each member of our organization makes an essential contribution to our success and the success of our clients. We offer interesting jobs in a prestigious, international environment and a competitive compensation & benefits package in a permanent employment position. We are committed to diversity in the workplace and we are an equal opportunity employer.

Clinical Research Associate

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. Regular travel is required.

Profile: By preference, you have a (para-) medical or scientific degree and at least one (1) year of clinical research experience including monitoring, or at least a minimum of two years experience in pharmaceutical data management or as a study coordinator. You are a detail oriented professional with good negotiation, time management and people skills.

Language requirements:
Belgium: Fluent in Dutch and English
Germany: Fluent in German and English
Japan: Fluent in Japanese and English

Clinical Project Manager

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.

Profile: By preference, you have a (para-) medical or scientific degree and at least four years of clinical research experience (monitoring). You have excellent planning and organizational skills with good negotiation, time management and people skills.

Language requirements:
Belgium: Fluent in Dutch and English
Germany: Fluent in German and English
USA: Fluent in English, additional languages are a plus

Clinical Safety Manager

Interested in joining a growing full-service Medical Device CRO, with global locations across the US, Europe and the Middle East? Build expertise and learn from your peers but more importantly, contribute to the success of some of the most innovating medical device trials in the industry.

Role Objective:
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.

Responsibilities:
  • Set-up and execute safety tasks within clinical projects in compliance with all requirements;
  • Be the liaison between all stakeholders (DSMB, CEC, CA, EC and Clients);
  • Primary contact for all safety related aspects within the organization;
  • Write, develop and maintain SOPs and workflows applicable for the Safety Department;
  • Supervise event narratives creation to assure accuracy and completeness;
  • Host and manage safety related meetings;
  • Assess adequacy of safety procedures to ensure study Safety issues are identified;
  • Functional management of the direct reports.
     

Qualifications:
A Higher educational degree (BSc, MSc) in a medical or science-related field, pharmacy, nursing is required. Prerequisite of minimum 5 year clinical research experience of which two years in the medical device/drug safety/(pharmaco)vigilance related function. Additional in depth knowledge of applicable European and FDA regulations and guidelines. Basic medical knowledge and a strong awareness of ICH/GCP. You are fluent in English. We are looking a strong communication with great organizational skills.

Job Type:
Full-time

Clinical Trial Submissions Manager

genae is involved in the development and commercialization of medical devices, biologics and therapies that change medical practice. To strengthen our team we are recruiting a Clinical Trial Submissions Manager in our Belgian (Antwerp) and German (Frankfurt) office.

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. Furthermore he/she will act as the subject matter expert for clinical teams and clients in terms of regulatory requirements and compliance as well as an intermediary between the different parties involved, which may include the genae Clinical Project Manager, Competent Authority, Notified Body, Health Insurance Agency, Ethical Committee and the client.

Education
• Higher educational degree (BSc, MSc) in a medical or science-related field; pharmacy, nursing or equivalent, healthcare professional qualification preferred.
Experience
• Relevant experience in clinical research and clinical trial submissions
• Knowledge of applicable laws, regulations and guidelines related to clinical trials
Languages
• English and German or French and Dutch 

Director Business Development

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.

Profile: You have a master’s degree in economic sciences or equivalent business experience and at least five years of experience in a Business Development role. You are knowledgeable about Clinical Research and related activities. You have excellent negotiation skills, a proven track record of successfully pitching for new business and the generation of new leads. You have excellent planning and organizational skills with good interpersonal, time-management and communication skills. You have a perseverant mindset and a positive attitude. You master MS Office programs and you are accurate, pro-active and service-minded with a strong analytical mind. You are fluent in English and by preference in more languages.

Quality & Training Manager / Associate

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.

Profile: By preference, you have a (para-) medical or scientific degree and at least four years of a combined experience in clinical research and quality management. You have a very good knowledge of ISO 9001, ICH-GCP and ISO 14155 with a strong focus on software validation and ICT-related processes. You excel in the planning, organization and communication of process related matters. You are fluent in English and by preference in other languages.

Sr. Clinical Research Associate

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.

Profile: By preference, you have a (para-) medical or scientific degree and at least three (3) years of clinical research experience (monitoring). You have excellent planning and organizational skills with good negotiation, time-management and people skills.

Language requirements:
Fluent in German and English