Associate Clinical Study Manager Location: Belgium Employment Type: Permanent, full-time Salary: Competitive, plus company car and benefits
We are currently working with a global Medical Devices company based in Belgium who is seeking individuals with Clinical Study design/implementation experience. Do you have solid working experience within the clinical study management or clinical project management or even strong background as a lead CRA within the Medical Devices industry? If yes then this new position is made for you!
Key tasks and responsibilities: *Designing, implementing and managing clinical projects and the assigned clinical areas; *Providing scientific support to the clinical projects, as well as managing clinical trials so that they comply with local/national/international regulatory requirements; *Participation in budget forecasting and preparation, ensuring that timelines are successful met and ensuring budgetary restrictions are observed; *Identification and promotion of strategies for the improvement of the quality of clinical research, as well as for the improvement of best practices in the clinical research department; *Proactive assessment of clinical project progression and development of strategic responses to identified issues and trends. *Interpreting study results and preparing summaries in preparation for regulatory submissions/publication; *Liaising with study investigators in order to provide oversight for papers, presentations and meetings which involve the presentation of clinical data; *Personnel management, to involve the leadership of research staff, management of resources and provision of guidance and support to direct reports regarding research priorities; *Encouragement of career growth and provision of training for new/existing clinical personnel.
Requirements: *BSc in Life Sciences, Bioengineering, or other biology-related degree; *Solid experience in the clinical research environment medical devices is requested; *Proven experience in direct study management (medical devices, ideally Class III); *Knowledge of clinical trial regulations and the ability to demonstrate applicable leadership skills.
Extra/beneficial knowledge and skills: *Level of English language to mother tongue standard is a must, as well as one other European language; if you do speak Flemish to a professional level that will be a major plus; *Excellent knowledge of clinical software; *Strong communication, project management and budgeting skills.
If this role would be of interest to you, and you possess the required skills and experience, please contact Yasmina Mallem on 2 for an informal discussion.
If you do not feel that this is the right role for you, please do not hesitate to forward these details on as we have a generous referral scheme in place.
Keywords: Medical devices; cardiovascular; active devices; pharmaceutical; biotechnology; clinical; research; clinical research; Belgium; English; French; Flemish; Dutch; German; project management; budgeting; regulatory; health sciences; Life Sciences; biostatistics; study management; clinical project.