CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com Job Summary With the supervision of higher levels of Leadership in Clinical Project Coordination, the Assistant Manager, Clinical Project Coordination is responsible for providing high-level clinical project management support to Clinical Project Managers, Directors, and study team to enable achievement of expected timelines, budgets, and quality standards. This role will entail both line management responsibilities described below in addition to operational responsibilities as a member of the Clinical Project Management Department at either a CPM or Sr CPC level, depending on experience . What You'll Do Manage direct reports within the CPC Team under supervision of a higher Level of CPC management; Participate in study allocation and development of the assigned members of the CPC Team. Provide direct supervision, guidance, and mentoring to CPA/Cs while encouraging independence and refinement of skills of those personnel. Conduct CPA/Cs performance evaluations under supervision of higher leadership level and work with staff to establish and reach their goals. Participate in management team performance assessment level calibration. Participate in discussions regarding overall global CPA/C group goals and key performance indicators; Responsible for communicating and assessing progress against goals with individual CPA/C direct reports. Work in collaboration with, and under the supervision of, Leadership of Clinical Project Coordination and Clinical Project Management to onboard new members for the CPC Team. Work in collaboration with, and under the supervision of, Leadership of Clinical Project Coordination and Clinical Project Management to manage day-to-day needs of CPC Team including personnel administrative tasks, training and support, issue resolution, and addressing employee needs / concerns. Review utilization reports & ensure direct reports meet utilization targets. Provide informed input during resourcing conversations on behalf of direct reports related to workloads, resourcing needs, and assignments. Maintain/update resourcing-related materials as requested, which may or may not entail engagement with the FinancialForce system. Ensure that CPA/Cs provide full clinical project coordination support for assigned trials, including support in the preparation of trial plans, development and maintenance of trial-related materials, preparation and documentation of trial team meetings, maintenance of trial-related tracking and clinical systems (CTMS, SSU, eTMF, SSRS, BI) and development of trial-related internal and external status reports. Serve as a resource to CPA/Cs in these processes. Provide backup support regarding CTI clinical system user account requests. Ensure and participate in training of role responsibilities for CPA/Cs, assists in the development of training and reference materials, and collaborates with Training Department to ensure all required training needs are being met. Utilize knowledge of clinical operations processes and systems to monitor compliance and participate and provide leadership in developing and implementing process improvement initiatives in Clinical Trial Operations. Communicate and meet regularly with Leadership of Clinical Project Coordination and Clinical Project Management to ensure consistent implementation of company policies and procedures, to develop or revise related training and SOPs as necessary, and to discuss CPA/Cs performance and resourcing. Provide expertise with clinical project management systems (i.e., Clinical Trial Management System [CTMS], electronic Trial Master File [eTMF], etc.) utilized within Clinical Trials and provide leadership and guidance to others utilizing these systems. May assist, as needed, with evaluating candidates for phone screens and interviews; participate in the interview process; and may provide input, as needed, with evaluating position level of new hires. Provide full CPC support for assigned studies, including support in preparing study plans, developing and maintaining study related materials, preparing and conducting study team meetings, maintaining study related tracking and clinical systems, tracking and preparing investigative site payments, developing study related internal and external status reports; serve as resource to others in these processes. Ensure Good Clinical Practice (GCP) / International Council for Harmonization (ICH) and Global Standard Operating Procedures (GSOP) compliance and implementation across Clinical Trials. Provide support in managing any third-party vendors. Participate in orientation of new clinical trial staff. What You'll Bring You must be fully eligible to live and work in the country you are applying from. CTI does not offer any Sponsorship Excellent verbal and written communication skills in English (and local language) Excellent organizational, record retention skills and time management skills Excellent customer service and interpersonal skills Demonstrates knowledge and understanding of overall drug development processes Ability to work with line management to improve operational skills of direct reports. Ability to work independently for most basic management responsibilities. May require guidance from manager or director on more difficult cases Ability to identify conflicts and follow proper escalation pathways, with manager or director support as needed Ability to handle multiple tasks and manage time efficiently At least 3 years of clinical research experience Bachelor’s degree in allied health fields such as nursing, pharmacy, or health / natural science Previous clinical research experience at CTI Strong knowledge of CTI Standard Operating Procedures (SOPs) and clinical trial processes Sound advanced knowledge of medical and pharmaceutical terminology Knowledge of Good Clinical Practice (GCP) / International Council for Harmonization (ICH) guidelines and applicable regulatory requirements Demonstrated understanding of clinical systems and ability to learn new systems Why CTI? Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through a dedicated training department. Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering hybrid work from home opportunities. We also encourage care for the world around us through our unique CTI Cares program. Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market. Important Note In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website ( www.ctifacts.com ) or from our verified LinkedIn page. Please Note We will never communicate with you via Microsoft Teams or text message We will never ask for your bank account information at any point during the recruitment process
