A a British multinational medical technology company focused on repairing, regenerating, and replacing soft and hard tissue
Primary Responsibilities
Clinical Study Management: Lead the planning, execution, and oversight of various clinical studies—including those conducted before and after product launch—in collaboration with global teams or external partners.
Regulatory Support: Contribute to regulatory documentation by preparing clinical study reports, international data submissions, clinical evaluation reports, technical files, and materials for regulatory consultations.
Project Coordination: Ensure timely completion of clinical projects by identifying potential risks and applying effective mitigation strategies.
Process Documentation: Develop and maintain standard operating procedures related to clinical affairs.
Cross-functional Collaboration: Act as a subject matter expert, providing clinical insights across internal teams and strategic groups.
Key Challenges
Balancing numerous projects with different clinical scopes and regulatory requirements
Maintaining high standards of quality and compliance across diverse activities
Anticipating challenges to prevent delays and ensure project success
Qualifications & Experience
Required:
Bachelor’s degree in Life Sciences or a related discipline (Master’s degree is a plus)
Experience in clinical development, preferably within the medical device, pharmaceutical, or biotech sectors
Familiarity with GCP, ISO 14155, and relevant regulatory standards
Strong skills in communication, organization, and project management
Proficiency in Microsoft Office tools
Preferred:
Hands-on experience with clinical trial software such as Medidata or Veeva Vault
Professional-level proficiency in English
Background in orthopedics or wound care
Core Competencies
Ability to work independently and take initiative
Flexibility and adaptability to shifting priorities
Strong discipline and attention to detail
Creative and analytical thinking
Clear and effective communication skills