Primary Focus: Design, execution, and oversight of clinical trials to generate safety and efficacy data.
Key Functions:
- Protocol Development: Designing Phase I–IV clinical trial protocols.
- Medical Monitoring: Overseeing patient safety and trial conduct.
- Site & Investigator Management: Selecting and supporting trial sites and investigators.
- Data Analysis & Interpretation: Reviewing clinical data for trends, safety signals, and efficacy outcomes.
- Scientific Communication: Contributing to publications, investigator brochures, and clinical sections of regulatory submissions.
- Cross-Functional Integration: Aligning clinical strategy with regulatory, commercial, and medical affairs.
- Cross-Functional Integration: Aligning clinical strategy with regulatory, commercial, and medical affairs.
Typical Roles:
- Clinical Research Scientist
- Medical Monitor
- Clinical Project Manager
- Director of Clinical Development
Clinical Regulatory: Compliance, Submission & Liaison
Primary Focus: Ensuring clinical trials and product development comply with global regulatory requirements.
Key Functions:
- Regulatory Strategy: Developing submission plans aligned with clinical milestones.
- Dossier Preparation: Compiling clinical data into CTD/eCTD formats for INDs, NDAs, BLAs, etc.
- Health Authority Interactions: Managing communications with FDA, EMA, PMDA, and others.
- Compliance Oversight: Ensuring trials meet ICH-GCP, local regulations, and ethical standards.
- Labeling & Advertising Review: Ensuring promotional materials reflect approved claims and clinical data.
- Regulatory Intelligence: Monitoring changes in global regulations and guiding clinical teams accordingly.
Typical Roles:
- Regulatory Affairs Manager (Clinical)
- Regulatory Submission Specialist
- Regulatory Intelligence Analyst
- Clinical Regulatory Strategist
Intersections:
- Clinical Affairs generates the data.
- Clinical Regulatory ensures that data is formatted, interpreted, and submitted in compliance with global standards.
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