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, take ownership of your initiative, to go for it and we guarantee that you will then appreciate the result of your work, whether individually, as a team or companywide as Flen Health. As an entrepreneur, 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 ecosystem, enthusiastic colleagues, and an attractive remuneration package.
We are looking for a Clinical Project Manager for an immediate start to reinforce our Clinical Affairs department. This is a fixed-term contract to cover a maternity leave based in our office in Belgium and reporting directly to the Vice President Research & Development, Clinical, Quality & Regulatory Affairs.
This position would suit you perfectly if you are driven by a desire to improve patients’ health and have the desire to make things happen.
What we offer:
- Excellent working conditions
- An innovative and inspiring work environment
- Independent project work and responsibilities within a professional team
- Career prospect
- Learning and development opportunities
- Competitive remuneration according to experience
- For day-to-day operations of projects, you manage and provide accountability according to ICH/GCP and all other applicable laws, rules, and regulations, Good Clinical Practice for medical device trials in Europe (ISO 14155) and local regulations. Knowledge of US regulations (21 CFR 812 and other sections) is an advantage
- You maintain in depth knowledge of protocol, therapeutic area and indication
- You 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
- You develop operational project plans and provide cross-functional oversight and deliverables
- You manage risk assessment and execution
- You perform quality checks on submission documents and site essential documents
- You prepare and approve informed consent forms
- In close cooperation with Regulatory Affairs, you review pertinent regulations to develop proactive solutions, in close cooperation with Regulatory Affairs department
- You coordinate and manage project start-up, project maintenance, and project close-out activities
- You 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
- You provide project management oversight and communicate changes to other clinical/medical team members and line manager
- You develop Study management tools, including but not limited to Communication Plan, Clinical Monitoring Plan, and other study-specific documents and management tools
- Where appropriate, you provide input 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 qualifications & experience:
- You hold a degree (Bachelor’s or Master’s) in Life Science or related field
- You demonstrate 3-5 years working experience within pharmaceutical and/or Biotech industry
- CRO prior experience with medical devices trials is preferred
- You have in-depth knowledge of applicable laws, clinical practices' standards (ICH/GCP, ISO 14155) and European regulations. Knowledge of US regulations (21 CFR 812 and other sections) is considered as an advantage
- You possess excellent project management and organizational skills, and you are able to meet strict deadlines
- You pay high attention to detail and quality standard
- You are fluent in English, both written and spoken; other languages as Dutch, French or German are an asset
Are you interested in working with an ambitious and very dedicated team?
Please submit your application, CV and motivation letter below OR send them to the following email address: email@example.com