Clinical Research Scientist

Clinical Research Scientist

• Contribute to the design of clinical trial protocols and study methodologies.
• Collaborate with medical, regulatory, and biostatistics teams to ensure study feasibility.
• Participate in site selection and investigator meetings.
• Oversee and monitor ongoing clinical trials to ensure adherence to protocol, ICH-GCP, and regulatory standards.
• Support data collection, validation, and quality control activities.
• Liaise with investigators, research coordinators, and clinical operations teams.
• Analyze clinical data and interpret study outcomes.
• Prepare scientific reports, publications, and regulatory submission documents (e.g., clinical study reports, investigator brochures).
• Present findings to internal teams, stakeholders, and external collaborators.
• Ensure compliance with FDA, EMA, and other international regulatory bodies.
• Maintain ethical standards and patient safety throughout the research process.
• Contribute to audits and inspections by regulatory authorities.
• Work with pharmacovigilance, medical affairs, and R&D to integrate trial data into broader development programs.
• Provide scientific input for new drug applications and lifecycle management.
• Support business development with clinical expertise when needed.