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 Assistant

Function: As Clinical Trial Assistant you will be responsible for the administrative and logistical support to the study team as well as for the coordination, tracking and maintenance of the clinical trial documentation. The Clinical Trial Assistant may also provide general office management support. She / he is part of the clinical trial team and works together with the CRA and Project Manager to make sure the trial is running smoothly. 

Profile: By preference, you have a Bachelor's degree in life science or equivalent by at least 1 year business experience. You have excellent planning, organizational and prioritization skills. You master Excel and other office programs. You are pro-active, have great attention to detail and excellent oral and written communication skills. 

Language requirements:
Fluent in Dutch and English, additional languages are a plus

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.

Manager Data Engineering

Function: The Manager Data Engineering is part of genae’s Business Intelligence technology team. You are responsible for data services including ETL design and implementation, data warehouse architecture and maintenance, and data quality automation. The ideal candidate has solid SQL experience and seeks to create highly performant queries that result in robust data warehouse tables that drive business insight. This position reports to the CTO and works closely with the management team to understand and replace existing ad-hoc data access and analysis. The candidate is smart, self-driven, and wants to be part of a culture of innovation and creativity, supporting genae’s digital transformation. You build partnerships with key business users to understand data, reporting, and analytical requirements. You design, build, integrate data from various resources (SQL Server, Azure SQL, MS SharePoint, MS CRM Online, various web-services) and create solid ETL pipelines. You design, develop and maintain genae’s core data warehouse and work closely with developers to create and improve data flows between internal/external systems and the data warehouse. You document and communicate changes to the data warehouse environment and educate business analysts on data access best practices. On an ongoing basis, you create optimized views to address specific business use cases, and you explore and evaluate new technologies.

Profile: By preference, you have a bachelor's or master's degree in computer sciences / analytics and several years of relevant experience in software development, analytics and design. You have excellent SQL query writing and data modeling skills (conceptual, logical and physical). You are experienced in developing, maintaining, and administering MS SQL Server and have hands-on experience in ETL coding and maintenance. Experience with .NET C# development is a strong plus. You are fluent in one or more of the following Microsoft platforms: Power BI, Dynamics NAV, SharePoint OnPremise/Online. You are a curious, self-motivated and resourceful thinker and you combine good negotiation, time management and people skills.

Language requirements:
Fluent in Dutch and English

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