Flen Health is an international family owned company with ambitious growth plans in the pharmaceutical and medical device technological domain. Flen Health has a range of products for wound and skin care, several new products in the pipeline and research cooperation agreements in Europe and the USA.
At Flen Health, we are convinced that we do help people live the life they love through developing innovative technologies and bringing these to patients across the globe. We focus on patients with topical inflammatory and infectious diseases.
At Flen Health, we expect you to show grit, to take ownership of your initiatives, to go for it and we guarantee that you will then appreciate the result of your work, whether individually, as a team or company-wide as Flen Health. As an intrapreneur, you will enjoy working in a multicultural diverse environment where trust and open communication are key, and where a positive can do attitude drives sustainable growth. We offer a flexible working eco-system, enthusiastic colleagues, and an attractive remuneration package.
We are looking for a Clinical Trial Project Manager to act as project manager for local and international clinical trials for Medical Devices. His great asset will be his experience within Medical Devices especially in wound management for all different types of wounds including chronic and acute wounds. This full-time and permanent position will be located either in Germany (Home-Office ), in Belgium, in the Netherlands, in Luxembourg or in UK (Home-Office).
What we offer:
- Excellent working conditions
- An innovative and inspiring work environment
- Independent project work & responsibilities within a professional team
- Career prospect
- Learning and development opportunities
- Competitive remuneration according to experience
- Manage and provide accountability for day-to-day operations of projects, according to ICH/GCP and all other applicable laws, rules, and regulations, Good Clinical Practice for medical device trials in the Europe (ISO 14155), and local regulations; knowledge of US (21 CFR 812 and other sections) is an advantage
- Maintain in depth knowledge of protocol, therapeutic area, and indication
- Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable; development of study protocols is desired
- Provide cross-functional oversight and deliverables
- Develop operational project plans
- Manage risk assessment and execution
- Perform quality checks on submission documents and site essential documents
- Prepare and approve informed consent forms
- Review pertinent regulations to develop proactive solutions, in close cooperation with Regulatory Affairs
- Ability to coordinate and manage project start-up, project maintenance, and project close-out activities
- Track study status and progress according to milestones, identify and anticipate potential issues or challenges, and work closely with team and communicate to line manager to develop appropriate solutions
- Provide project management oversight to other clinical/medical team members
- Develop Study management tools, including but not limited to communication plan, Clinical Monitoring Plan, and other study-specific documents and management tools
- Communicate change in scope to clinical/medical team and line manager
- May be responsible for other projects and responsibilities as assigned
- Provide input (as applicable) on the Study protocol/Clinical Investigation Plan, on the edit check specifications, on the data analysis plan, on the Analysis and on the final study report
Your profile & qualifications:
- A Bachelor’s degree in Life Sciences or related field with a minimum of 5 years of related medical device industry experience (i.e. project management), OR a Master’s degree in Life Sciences or related field with minimum 3 years related medical device industry experience
- Prior experience with medical devices trials is preferred
- Strong communication skills (oral and written) and demonstrating team-integrative attitude and behaviour
- High attention to detail and quality standard
- Strong time and project management skills
- Demonstrate measurable knowledge of Good Clinical Practice for medical device trials in the Europe (ISO 14155), and local regulations. Knowledge of US (21 CFR 812 and other sections) is an advantage
- Proficient with all Microsoft Office applications (Word, Excel, Power Point, Project, etc.), experience in Data capturing tools is a plus
- English: fluent; Other languages such as e.g. German or Dutch would be an asset
Are you interested in working with an ambitious and very dedicated team?
Please send your application, CV and covering letter to the following email address: email@example.com