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Assistant Clinical Trial Manager
Proactively monitor study status and develop and implement a risk mitigation strategy as needed to ensure the study progresses according to plan
Ensure compliance with relevant regulations and guidelines by maintaining regular contact with external vendors and internal or external CRAs. Complete sponsors’ review of monitoring reports. Identify potential study issues and recommend/implement solutions.
Organize and manage internal team meetings, investigator meetings and other trial-specific meetings
Actively participate in data review and cleaning for the trial (extent dependent on level of services outsourced)
Maintain a working knowledge of all relevant functional area SOPs and ensure adherence in the conduct of work-related activities
Oversee set up and maintenance of the Trial Master File. Review of essential regulatory documents supporting study conduct.
Maintain contact with and act as a liaison and resource for investigational sites
Perform monitoring visits including site qualification, initiation, interim monitoring and closeouts
Visit report and site communication preparation
Prepare for and participate in sponsor and FDA audits
Reviews site data remotely (if possible) in preparation for study visits and as a part of overall study data cleaning
Performs other additional job related duties as required.
Excellent oral and written communications.
Strong computer skills including knowledge of Microsoft Excel, Word, and Outlook and EDC
Ability to work within established timelines, in a fast paced environment
Excellent organizational and priority management skills
Sound knowledge of medical terminology
Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact
BS/BA degree in science
2 – 3 years of prior experience
Experience as a lead CRA and prior experience managing clinical trials for or within the biotech or pharmaceutical industry, including CRO/vendor management and clinical site monitoring,
Prior oncology experience preferred
Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required
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