CRO-Clinical Trials Manager

Job Title: Clinical Trials Manager The Clinical Trial Manager (CTM) ensures the on time and high-quality delivery of project specific on-site and remote monitoring services; accountability for clinical monitoring team training compliance; tracking of critical project tasks; strategic and tactical study enrollment support and planning. The CTM is responsible for managing the planning, implementation, and tracking of clinical monitoring. The position requires an active role in developing the plan and monitoring of resource allocation to ensure compliance with all aspects of the plan. The CTM serves as a proactive member of the core project team, liaising closely with the Project Manager (PM) on clinical operation related project issues to ensure successful completion of applicable activities and project deliverables are within required timelines.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Employee performs all, part, and/or any combination of the duties listed below.

• Manages key site and monitoring related study metrics and reports progress on clinical monitoring tasks or benchmarks.
• Helps in the development of study-specific plans and documents such as, but not limited to, Monitoring Plan (MP), Pharmacy Manual, Project Management Communication Plan, monitoring report and follow-up letter templates, SIV slides, and CRA training materials. Review and contribute to CRF guidelines and edit checks. Contributes to the development and/or review of clinical protocols, informed consent forms, and any other clinical research related documents as assigned.
• Ensures GCP compliance and execution of assigned clinical research studies by overseeing the clinical monitoring aspects of assigned projects, including site start-up activities, clinical site management, monitoring, filing of monitoring related documents including site documents collected during monitoring visits in the Trial Master File. Participate in QC review of TMF documents related to site and monitoring activities.
• Provides enrollment tracking and support. Monitors site compliance with eDiaries, data entry and query resolution. Responsible for timelines and quality of clinical monitoring team deliverables, identification of risks and issues and escalation to PM and CRA Manager, for assigned projects.
• Ensures CRA compliance to the Monitoring Plan, conducts CRA training, and maintains documentation and tracking of training.
• Communicates monitoring and site management updates and/or issues to team during the Sponsor and internal team meetings.
• Reviews and tracks monitoring visit reports and follow-up letters. Assures adherence to study timelines for report and follow-up letter submission and finalization.
• Develops clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables. This includes developing clinical monitoring study tools and templates for CRAs.
• Promotes operational efficiency, teamwork, and high morale among CRAs.
• Proactively prevents, identifies and tracks issues related to study processes, monitoring, or site issues. Works closely with the CRAs to ensure resolution of all action items.
• Works closely with PM and CRA Manager for resourcing issues and escalates pertinent CRA performance and site compliance issues when necessary.
• Travel is required up to 20%.

SUPERVISORY RESPONSIBILITIES

Position may supervise assigned CRAs including, but not limited to review/approval of timesheets and expenses. Position requires experience and judgment to accomplish project defined goals. Ability to train and provide higher level guidance in monitoring and the development of monitoring tools.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. EDUCATION and/or EXPERIENCE A degree in life sciences or nursing qualification preferred, but not required.A minimum of 6 years clinical research experience with at least 1 year as a CTM or Lead CRA. Ability to mentor and train CRAs in a positive and effective manner. In-depth knowledge of clinical trials and the critical elements for success in clinical trials. Demonstrates the ability to successfully manage project issues. Seeks to understand all contributing factors and proactively identifies and addresses problems. Proposes, implements, and evaluates appropriate resolutions. Proven organizational abilities, and excellent written and oral communication skills. SKILLS and/or ABILITIES Ability to facilitate a teamwork philosophy with a positive attitude. Extensive organizing and coordinating skills, teaching and facilitation skills, ability to assess training needs and objectives. Experience overseeing and coordinating the work of others. Ability to work effectively and efficiently handling multiple tasks simultaneously. Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity. Ability to manage multiple deadlines. Must have a ‘can-do’ attitude.