Director, External Research and Development
Amgen
Clinical Trial Manager II
ICON plc
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
SeniorLead
About the role
- Leads the clinical team to ensure successful delivery of clinical studies in accordance with protocol, budget, SOPs, policies and regulations
- Manages and prioritizes clinical deliverables like site recruitment, selection, patient recruitment/enrollment, and data monitoring
- Creates and administers clinical and site training plans; ensures team understands responsibilities and performance standards
- Reviews metrics and monitors team and individual performance; provides feedback and shares performance with functional manager
- Collaborates with cross-functional groups including site monitors, site managers, biometrics team to achieve data delivery
- Ensures timely data entry, query resolution, on/off site data review for quality data deliverables
- Maintains knowledge of study resource requirements, burn rates; forecasts and plans according to contract units/hours
- Identifies risks and issues; establishes contingency and mitigation plans; liaises for clinical monitoring and site risks
- Ensures quality standards and regulatory compliance; facilitates audits and inspections; oversees essential document filing
- Communicates with sponsor, project manager, functional leads; leads study team meetings and presents internally/externally
Requirements
- Bachelor’s degree in a health, life sciences or other relevant field of study
- 8 years’ relevant experience
- Advanced project management skills
- Excellent leadership and influencing skills
- High proficiency with Microsoft Office and company collaboration applications
