Clinical Research Scientist

4 weeks ago

Delhi, India Green HR Solutions Full time
Hiring for USA based MNC, pls apply if following Job Description suits your aspirations.
We are looking for a highly skilled and detail-oriented Clinical Research Scientist to support the design, execution, and analysis of clinical trials. The role involves working closely with cross-functional teams to ensure studies are scientifically sound, ethically compliant, and meet regulatory requirements. The ideal candidate has strong expertise in clinical research, data analysis, and medical writing, with the ability to translate research outcomes into impactful clinical insights.
- 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.

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