Clinical Trials Manager

Overview The Clinical Trials Manager at the Alliance for Clinical Trials in Oncology will manage and coordinate a variety of complex and independent activities involved with planning and conducting multiple research studies for the Alliance. Responsibilities Assist the Director of Protocol Operations in assessing overall workload and assigning committee and study responsibilities. Train, direct and monitor the work of protocol coordinators to ensure accuracy and adherence to external and internal timelines. Conduct meetings with assigned protocol coordinators, and at times with senior protocol coordinators, to implement and ensure compliance with standard operating procedures. Manage vacation, sick leave, and other absences, as well as the annual employee evaluation process for assigned protocol coordinators with oversight from the Director of Protocol Operations. Assist in the selection of candidates and in the hiring process for new protocol coordinators. Assist in the development and implementation of relevant policies, procedures, and guidelines for protocol operations. Assist in the execution of the Central Protocol Operation Program’s mission statement, as well as the Alliance’s overall strategic plan. Manage committee activities and committee study teams in the development and implementation of Alliance protocols. Draft protocol and consent documents and model protocol templates, ensuring compliance with federal guidelines, the Alliance model protocol, and current Alliance policy and procedures. Format, proofread, and edit protocols for designated committee assignments. Distribute protocol drafts for review, integrate technical and scientific information from multiple sources and incorporate necessary revisions under the supervision of Alliance Executive Officers and other senior leadership. Identify and resolve impediments to the protocol development process in collaboration with senior leadership. Act as liaison to funding agencies (NCI CTEP and DCP staff), the Cancer Trials Support Unit, and the NCI Central Institutional Review Board regarding studies in development or undergoing revision, and monitor progress of review performed by these organizations. Identify and seek resolution of issues raised during the review process by these agencies. Prepare responses to reviews, revise the protocol document accordingly, and submit necessary supporting documentation in collaboration with the study team. Ensure that protocols meet pharmaceutical collaborator requirements in conjunction with Executive Officer and Director of Pharmaceutical and Regulatory Affairs. Prepare amendments for active protocols as necessary. Obtain necessary approvals, including submission to the Alliance Data and Safety Monitoring Board, other Alliance committees, the CIRB, and NCI CTEP/DCP. Prepare and distribute amendments to the group membership. Identify emergent issues arising during development and implementation of studies and seek resolution. Implement emergency procedures as required in conjunction with Executive Officers, Director of Protocol Operations, Director of Pharmaceutical and Regulatory Affairs, etc. Field telephone and email inquiries regarding study conduct from clinical research and health‑related professionals, including data managers, nurses, and physicians. Attend group meetings, core committee meetings and other meetings as assigned. Report at meetings the status of protocols under development or in progress. Provide information and assistance regarding protocol development procedures. Coordinate events, research logistics, assist with planning and preparing presentations, event outreach, and post‑event write‑ups. Assist with other administrative projects as needed and acquire higher‑level guidance and skills. Perform other related work as needed. Application Documents Resume (required). Minimum Qualifications College or university degree in a related field. 2‑5 years of work experience in a related discipline. Preferred Qualifications Master’s degree in biology, public health, or another scientific or health‑related field. Bachelor’s degree with a minimum of 4 years of experience in oncology clinical trials in an academic or community medical center or pharmaceutical industry. Experience with research or scientific writing. Experience with clinical trials research. Preferred Competencies Excellent verbal and written communication skills demonstrated in a research or scientific setting. Ability to handle multiple tasks and assignments simultaneously. Excellent organizational and leadership skills. Ability to communicate well with group members, industry representatives, and federal agencies. Working Conditions Willingness to travel approximately 5% of the year. Benefits Eligible for the University of Chicago benefits programs and resources, including health, retirement, and paid time off. Pay Range $60,000.00 - $85,000.00 per year. EEO Statement The University of Chicago is an equal‑opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. All offers of employment are contingent upon a background check that includes a review of conviction history. #J-18808-Ljbffr