Clinical Trial Manager

Summary

Join RQM+, the leading MedTech service provider, as a Clinical Trial Manager (CTM) to oversee clinical monitoring activities, develop and implement plans, and ensure compliance with Good Clinical Practices.

Requirements

• BS/BA (or equivalent) in one of the life sciences
• Minimum of 5 years direct experience in clinical studies
• Minimum of 4 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis
• Minimum of 1 year as a successful Lead CRA or Clinical Trial Manager
• Equivalent combination of education, training, and experience
• Thorough knowledge of clinical research process
• Strong communication skills (verbal and written) to express complex ideas
• Excellent organizational and interpersonal skills
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
• Ability to manage multiple priorities within various clinical trials
• Ability to reason independently and recommend specific solutions in clinical settings
• Understanding of basic data processing functions, including electronic data capture
• Working knowledge of current ICH GCP guidelines and applicable regulations
• Ability to work independently, prioritize and work with a matrix team environment
• Working knowledge of Word, Excel, and PowerPoint
• Prior experience in electronic data capture (EDC) preferred
• Ability to mentor CRAs
• Willingness and ability to travel domestically and internationally, as required

Responsibilities

• Responsible for all activities related to implementation and execution of clinical studies
• Works with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope
• Serves as client advocate within RQM+
• Develops and implements Clinical Monitoring Plan
• Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes
• Coordinates site feasibility activities such as site identification, recruitment, and selection
• Coordinates Regulatory document collection and review
• Schedules and manages all site visits
• Develops site/monitoring tools and training materials
• Reviews and identifies trends in enrollment and data entry at sites and proactively interfaces with clinical monitoring team and client to identify solutions
• Coordinates and oversees daily operations of clinical monitoring team
• Sets and enforces project timelines with the assigned study team
• Coordinates remote review of clinical data within EDC system
• Oversees monitoring visit schedule to ensure compliance with frequency set forth in contract
• Reviews and approves trip reports and follow-up letters within the required timeframe
• Schedules and manages CRA project team meetings
• Ensures CRAs assigned to team receive therapeutic and project-specific training
• Manages quality and regulatory compliance among clinical monitoring team and investigational sites
• Manages project milestones and proactively addresses deficiencies
• Attends and provides information at client teleconferences/team meetings
• Assists Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization
• Serves as CRA mentor and performs accompanied field assessment visits as required
• Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA
• Ensures that the appropriate RQM+ and/or sponsor SOPs are adhered to
• Ensures all project documentation is appropriately filed per RQM+ SOPs
• Assists PM in preparation of audit responses, as appropriate
• Assists PM with preparation of information for inclusion in monthly report to client
• Assists PM in review of project budgets, monitoring costs, potential overruns, and propose/implement cost effective solutions
• If requested, reviews and approves CRA travel expenses and time sheets