Clinical Expert
TFS, Denmark

Clinical expert

• Clinical evaluation

• Clinical data experts
• Data analysis
• Literature search

• Usability engineering
• Communication with clinical

Expected competences:

1. Medical writer (English)
2. Scientific background - PhD degree
3. Education: human biology, medicine, etc.
4. Domain knowledge - Substantial knowledge of intravascular / cardiologic therapeutic areas, associated risk, clinical settings, procedures, regulatory/scientific guidelines and key statistical concepts.
5. Knowing audience expectations - Understand audience (NB, doctors, scientists).
6. Writing skills - Logical and succinct with accurate data interpretation and representation. Ability to write clearly, with focus and direction with intended audience in mind.
7. Data integrity - Maintain accuracy, consistency and security of data using stringent document management systems.
8. Self-maintaining competences skills - Keep abreast of new relevant information, and undergo regular new knowledge and online courses to enhance skills. Self-identifying gaps and provide suggestions for solutions.
9. Clarity - Establishes clear objectives, organizes ideas and embraces creativity. Ability to write quality content that readers will understand.
10. Literature search - Uses well-planned search strategy, appropriate keywords and a variety of sources when researching journal articles and medical research papers.
11. An independent outlook - Performs critical content reviews, correctly interprets results, identifies potential limitations and discusses unexpected findings.
12. Interpersonal skills - Well-honed verbal, non-verbal and listening skills for problem solving, negotiation and decision-making.
13. Ability to use skills of argument identification, analysis, and evaluation.
14. Self-Activation/Evaluation Skill: Ability for self-motivation and evaluation.
15. Project management skills - Highly organized, proactive, respects metrics driven timelines and accountability for quality. Accepts responsibilities and delegates efficiently.
16. Ability to take the proactive initiative (be a self-starter) and to evaluate one’s own work and the work of others.
17. Good communication skills (with clinicians, NB and stakeholders)
18. Documented experience with clinical requirements from MEDDEV, ISO, GHTF, IMRF, FDA, as well as MDR, ISO 13485, ISO 14971
19. Language requirements: English, Danish

Job Rewards and Benefits