What are the responsibilities and job description for the Clinical Trial Manager/Sr. Clinical Trial Manager position at Celldex?
Overview
As the operational leader of the study team, the Clinical Trial Manager / Sr. Clinical Trial MAnager (CTM) works closely with internal team members and vendors ensuring clinical trials are completed according to protocol, SOPs, ICH / GCP / regulatory guidelines, and company goals while ensuring timely delivery and budget adherence. Clinical Trial Managers at Celldex maintain highly visible responsibilities and accountability for their projects. This role reports to the Senior Director of Clinical Operations. This role can be worked out of our New Haven, CT or Fall River, MA site and will include occasional travel to vendor sites.
Responsibilities
- Comprehensive oversight of operational aspects of assigned clinical trials
- Monitoring of study progress : ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CROs, laboratories, etc.s as applicable. Completing sponsor's review of monitoring reports and periodic review of data quality. Identifying potential study issues and recommending and implementing solutions or corrective actions as needed.
- Serving as a liaison and resource for investigational sites
- Organizing and managing internal cross-functional study team meetings and other trial-specific meetings
- For studies which are outsourced to CRO partners, management of CRO interactions, including sponsor oversight of relevant functional activities (e.g., study management, monitoring, site management, and trial master file). Works with CRO to monitor budgets, plans and detailed timelines, and ensures that performance expectations are met.
- Participating in the development, review and implementation of departmental SOPs and processes
- Occasional travel to sites or vendors
Qualifications
Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.
