.**IQVIA Biotech is committed and dedicated to the small biotech & biopharma companies we support.****Opportunities available for an experienced Clinical Trial Manager II or Senior Clinical Trial Manager.****Previous clinical trial management and CRO experience preferred.****Therapeutic **requirements/preference**: any of the following **Oncology/Hematology/CAR** T/Cell & Gene Therapy.**- BS/BA (or equivalent) in one of the life sciences plus a minimum of 4 years direct experience in clinical studies- At least 2 years' experience as a Clinical Monitor/CRA, as well as experience in data handling or analysis.- Prior experience as a Clinical Research Associate. (strongly preferred)**Our** **Trial Managers are responsible for all activities related to implementation and execution of clinical studies and the delivery of study **metrics/deliverables.*****ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES**:Responsible for all activities related to implementation and execution of clinical studies that include:Client Duties/Responsibilities:- Work with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope. Communicate and document all interactions with client as required by SOP.- Serve as client advocate within IQVIA Biotech.- Develop and implement Clinical Monitoring Plan.Team Duties/Responsibilities:Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:Coordinate site management activities:- Site identification, recruitment, and selection.- Regulatory document collection and review.- Overall scheduling and management of all site visits.- Develop site/monitoring tools and training materials.- Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.Coordinate and oversee daily operations of clinical monitoring team:- Set and enforce project timelines with the assigned study team.- Coordinate remote review of clinical data within EDC system.- Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract.- Review and approve trip reports and follow-up letters within required timeframe.- Schedule and manage weekly CRA project team meetings.- Ensure CRAs assigned to team receive therapeutic and project-specific training.- Manage quality and regulatory compliance among clinical monitoring team and investigational sites.Manage project milestones and proactively address deficiencies:- Attend and provide information at monthly projections meetings.- Attend and provide information at weekly client teleconferences/team meetings.- Assist Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization