.Internal Job Description- ** Experience managing clinical trials in LATAM and North America(REQUIRED)**:- ** Strong Cardiovascular Therapeutic experience**:- **3+ years of Clinical Trial Management experience (CRO experience preferred)****BASIC FUNCTIONS**:Responsible for the successful planning, implementation and execution of contracted clinical monitoring activities.
Functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial.
Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by IQVIA Biotech and its clients.
**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.Manage CRA performance:- Define and implement functional standards, goals, and expectations with clinical monitoring team.- Serve as CRA mentor and perform accompanied field assessment visits as required