The Clinical Trial Manager / Senior Clinical Trial Manager works closely with internal team members and vendors to ensure that assigned clinical trials are conducted per protocol, in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and established study budgets. The first few months will require travel to the Branford, CT office.
Individual responsibilities include:
Comprehensive oversight of operational aspects of assigned clinical trials
Management of Clinical Research Organization (CRO) interactions, including sponsor oversight of relevant functional activities (e.g., study management, monitoring, site management, and project master files). Works with CRO to revise scope of service agreements, budgets, plans and detailed timelines, and ensures that performance expectations are met.
Monitoring of study progress: ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs 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; reviewing investigator contracts and site payments
Occasionally travelling to CRO/vendor facilities and/or investigative sites to train and assess study team and CRAs
Organizing and managing internal team meetings and other trial-specific meetings
Participating in the development, review and implementation of departmental SOPs and processes
Other job related duties as assigned.
Excellent oral and written communications.
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
Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact
BS/BA degree in science or similar area.
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 experience required with prior experience managing breast cancer trials preferred
In-depth knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required