What are the responsibilities and job description for the Senior Clinical Trial Manager/Associate Director position at Pheon Therapeutics?
Responsibilities:
Pheon’s Senior Clinical Trial Manager/Associate Director will collaborate with Pheon’s Head of Development Operations and Sciences to provide key operational oversight and support of all clinical trial activities including vendor oversight and management, from study initiation to closure.
- Lead Clinical Operations activities for one or more of Pheon’s clinical stage programs.
- Contribute to early and late phase clinical development strategy.
- Be accountable for implementing clinical development strategy by planning for and execution on early and late phase clinical projects.
- Work independently, provide input into and oversee development of clinical plans, study plans, and clinical documents (synopses, protocols, ICFs, IBs and CSRs)
- Proactively manage and oversee sites, CROs, and all other study-related vendors to ensure trial deliverables and performance goals are met and high level of operational excellence is maintained
- Plan and lead site start-up, directing both Pheon-led and CRO-led start-up activities
- Manage studies within agreed timelines and budget
- Manage compliance and quality of a clinical trial, including maintaining accurate documentation of trial progress
- Oversee set-up, technical integrations, and maintenance of clinical systems such as databases, eTMF, central reading, central/specialty labs, and other trial execution and/or data collection platforms
- Ensure all trials are conducted according to relevant ICH/GCP guidelines and applicable local regulations
Qualifications:
- The successful candidate will have clinical operations experience in oncology and in early phase drug development.
- Bachelors Degree in a technical discipline, e.g., life sciences, engineering, etc., preferred.
- Strong people and project management skills
- Has served as an operational expert in clinical trial activities, including site start-up activities
- Minimum of 8 years of clinical operations experience in a pharmaceutical or biotech or CRO setting, including a minimum of 3 years of experience in managing clinical trial vendors
- Prior site experience strongly preferred
- Demonstrated leadership skills and ability to lead, direct and support cross-functional teams
- Strong interpersonal, organizational, and multi-tasking skills
- Excellent knowledge and understanding of ICH/GCP and EU Guidelines for conducting clinical trials, and have inspection experience