Clinical Project Lead Job Description Template
Our company is looking for a Clinical Project Lead to join our team.
Responsibilities:
- Utilizes appropriate IT systems and ensures that clinical trial team utilizes and updates systems and tools to enable successful trial execution;
- Identifies operational issues across protocols and ensures resolution;
- May serve as direct line manager for one or more Clinical Operations team members; conducts annual performance evaluations;
- Implements best industry practice standards across assigned studies;
- Participates in Quality Assurance efforts;
- Provides strategic and tactical guidance in risk management of clinical trial execution; develops and executes risk mitigation plans;
- Oversees study vendors and contractors to ensure clinical trials are executed with high quality and within timelines and established budget parameters;
- Leads project specific meetings with executive management team;
- Participates in process improvement initiatives to increase quality, productivity, and efficiency of the Clinical Trial Management functions;
- Achieves high quality execution of clinical trials that are in compliance with GCP and regulatory requirements;
- Provides guidance on the development and implementation of clinical protocols;
- Participates in the development and management of project budgets; proactively manages study budgets, including accurate forecasting and cost accruals;
- Maintains optimal relationships with key internal partners and stakeholders to enable successful execution of trials;
- Negotiates vendor contract terms and ensures proper execution.
Requirements:
- Working knowledge of ex-US regulatory requirements;
- Minimum of eight (8) years of relevant Clinical Operations experience including at least three (3) years of experience in clinical trial management;
- Demonstrated knowledge in several relevant therapeutic areas; experience in rare disease indications a plus;
- Proficiency in MS Office including Word, Excel, and PowerPoint; Project and Visio a plus;
- Bachelor’s degree preferred.