Clinical Research Scientist
5 days ago
Masis Professional Group is seeking a highly skilled and motivated Clinical Scientist and Liaison Manager to join their dynamic clinical development team.
This role involves a range of responsibilities, including protocol development, medical writing, regulatory submissions, data management, safety reporting, and communication.
Key Responsibilities:
- Design, implement, and manage clinical research documents and studies to support product development and regulatory approval.
- Analyze and interpret scientific & clinical data, ensuring accuracy and scientific integrity.
- Ensure all clinical trial documentation complies with regulatory requirements, company policies, and ethical standards.
- Prepare and present clinical study reports, summaries, and publications for internal and external dissemination.
- Monitor and report study progress to relevant authorities and stakeholders.
Stakeholder Liaison:
- Serve as the main point of contact between the company, clinical sites, and external partners, including regulatory bodies and key opinion leaders (KOLs).
- Facilitate clear and consistent communication to address any inquiries, concerns, or updates related to clinical projects.
- Build and maintain strong relationships with clinical investigators, healthcare professionals, and other stakeholders.
R&D Strategy Support:
- Contribute to the development of clinical strategies and trial designs that align with company objectives.
- Provide scientific input and expertise in the preparation of regulatory submissions and presentations.
- Support in licensing projects, clinical and indication strategy assessment.
Requirements:
- A minimum of 5 years' experience in clinical research or pharmaceutical industry role with proven experience in clinical science, project management and liaison responsibilities.
Education:
- MD or PhD or PharmD
Additional Requirements:
- Knowledge of Good Clinical Practices (GCP) and regulatory requirements.
- Travel as needed to clinical sites, conferences, and partner meetings.
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