Proficient in early clinical development methodology
The role involves leading or supporting the clinical protocol development process and serving as the responsible author for clinical protocols and amendments
Job Summary
The role involves leading or supporting the clinical protocol development process and serving as the responsible author for clinical protocols and amendments.
Candidates will collaborate with cross-functional partners to identify strategic sites, manage study budgets, and ensure recruitment commitments are met.
The position requires proactive risk mitigation, data analysis including safety trend detection, and coordination of dose escalation meetings with investigators.
Matching Summary
The role involves leading or supporting the clinical protocol development process and serving as the responsible author for clinical protocols and amendments.
Skills & Requirements
Must-have
Bachelor's degree in life science or healthcare
2+ years experience in clinical trials
Proficient in early clinical development methodology
Operational project management skills
Track record managing multiple trials concurrently
Working knowledge of ICH-GCP and regulations
Nice-to-have
Strong interpersonal collaboration skills
Ability to drive collaboration in high-paced changes
Leadership and influence capabilities
Tolerance for ambiguity and adaptability
Commitment to diversity, inclusion, and integrity
Key Requirements
Bachelors in life science/healthcare required
Advanced degree preferred (PhD/MD/PharmD/Masters)
Approximately 2+ years' experience in clinical trials