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Senior Clinical Trial Manager
2 months ago
Responsibilities:
Pheon’s Senior Clinical Trial Manager / Associate Director will collaborate with Pheon’s Head of Clinical Development to provide key operational oversight and support of all clinical trial activities including vendor oversight and management, from study initiation to closure.
- Independently lead Clinical Operations activities for one or more of Pheon’s clinical stage programs.
- Contribute to early phase clinical development strategy.
- Be accountable for implementing clinical development strategy by planning for and execution on early phase clinical projects.
- Work independently, provide input into and oversee development of clinical plans, study plans, and clinical documents (synopses, protocols, ICF’s, IB’s and CSR’s)
- 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, CTMS, eTMF, central reading, 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:
- Clinical operations experience in the biotech industry required.
- Oncology experience in early phase drug development required.
- Bachelor’s degree in life sciences 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 5 years of experience in managing CROs and clinical trial vendors.
- Excellent leadership skills and ability to lead, direct and support cross-functional teams.
- Strong interpersonal, organizational, and multi-tasking skills.
- Excellent knowledge and understanding of GCP/ICH and EU Guidelines for conducting clinical trials and have inspection experience.
- Ability to commute to Cambridge at least once per week.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
No Employment Agencies please, the Company is not responsible for any fees related to candidates that are unsolicited.
