Clinical Trial Manager

2 weeks ago

Hartford, United States BioCT Innovation Commons Full time

Overview Join a well-established and collaborative Clinical Operations team in a Clinical Trial Manager role with opportunity for career enrichment. As the operational leader of the study team, the 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 Head of Clinical Operations.

Occasional travel to the New Haven, CT office is required for onboarding and periodic meetings, as well as 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

Excellent oral and written communication skills Strong computer skills including knowledge of Microsoft Excel, Word, and Outlook Ability to work within established timelines, in a fast-paced environment Excellent organizational and priority management skills Strong interpersonal skills Education/Experience: BS/BA degree in science or similar area 3 – 5 years of prior experience managing clinical trials for or within the biotech or pharmaceutical industry, including CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management/biostatistics processes and pharmacovigilance Prior oncology or dermatology/allergy experience preferred In-depth knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required Phase 1-3 Experience preferred Monitoring Experience preferred

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