Clinical Trial Manager/Sr. Clinical Trial Manager

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

• 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
• Preferred experience with dermatology/allergy
• Phase 1-3 Experience preferred
• In-depth knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required
• Knowledge of and experience with EDC for clinical data capture. Experience with Medidata Rave is preferred.
• Excellent oral and written communications
• Knowledge of and demonstrated experience with clinical data standards is preferred.
• Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact.
• Excellent organizational and priority management skills
• Strong computer skills including knowledge of Microsoft Excel, Word, and Outlook
• Ability to work within established timelines, in a fast-paced environment.
• Ability to work with minimal supervision while communicating to manager issues related to quality, timelines, and budget.

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.