Apply on Employer Site

RQM+ · 21 hours ago

Clinical Trial Manager

United States

Full-time

Onsite

Senior Level

5+ years exp

RQM+ is a MedTech CRO focused on accelerating innovation to patient impact. The Clinical Trial Manager is responsible for the successful planning, implementation, and execution of clinical monitoring activities, ensuring compliance with Good Clinical Practices and effective communication with clients and internal teams.

Health CareMedicalMedical Device

Hiring Manager

Jessica Miller

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. Communicate and document all interactions with client as required by SOP

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

Qualification

Clinical research processClinical Trial ManagementData handling/analysisElectronic data captureICH GCP guidelinesCommunication skillsMentoring CRAsMicrosoft OfficeOrganizational skillsInterpersonal skills