MSI are looking for a Clinical Trial Leader to join a prestigious Biotechnology company based in the West Coast (USA) accountable for the strategic planning and execution of assigned early development global clinical trials.
- Displays leadership by creating a positive work environment by inspiring and influencing and encouraging mutual respect, instills innovation and accountability on a functional and project level, both locally and globally to implement and deliver the clinical development plan.
- Oversees cross-functional activities and ensures delivery of critical clinical trial documents such as vendor specifications, drug supply forecasting, monitoring and communication plans, biomarker sample management plans, quality of trial master files and clinical study report.
- Partners closely with Clinical Science to provide strategic, global operational input on protocol design, feasibility and ability to execute.
- Critically reviews and provides operational insights on protocols and informed consents.
- Plays a key role in country and site identification and selection and provides appropriate and strategic oversight throughout study
- Champions and demonstrates a patient and site-centric mindset including development and management of study-specific patient recruitment strategies
- Achieves study milestones and objectives within approved timelines.
- Manages operations resources through effective delegation of responsibilities; identifies resource needs and risks through proactive long range planning of study needs in partnership and overall direction with the Program Lead.
- Through strategic and critical thinking skills; identifies risks, and works with the team to manage and develop mitigation strategies.
Minimum Education / Qualification:
- Bachelor's degree or equivalent required (scientific or healthcare discipline preferred).
- 4-7 years clinical and drug development experience; ideally 3+ years clinical trial management experience including leading and managing cross functional teams
- Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the drug development process.