Summary

The Office of Surgical Research (OSR) within the Michael E. DeBakey Department of Surgery is seeking a Sr. Manager, Clinical Research – Oncology to supervise and oversee clinical research and financial activities in the Division of Surgical Oncology. The Sr. Manager, Clinical Research – Oncology will be responsible for supervising daily activities of clinical research staff supporting clinical oncology research protocols; ensuring accurate data collection, documentation, organization, and safety of research participants; and developing clinical trials budgets. The Sr. Manager, Clinical Research – Oncology will support the Director, Research Operations on various administrative, operational, and financial duties required to reach departmental goals and objectives. 

Job Duties

• Supports the Director, Research Operations overseeing the clinical research activities of the Division of Surgical Oncology in the Michael E. DeBakey Department of Surgery, including recruitment, supervision, training, scheduling, and daily operations of clinical research staff.
• Serves as the Division of Surgical Oncology clinical research manager and departmental liaison to the Dan L. Duncan Comprehensive Cancer Center, the Office of Surgical Research and to academic collaborators and sponsors at outside institutions.
• Manages strategy, planning, development, and clinical trial activities across all stages of study lifecycle including protocol design and development, site initiation, study execution, regulatory oversight, and closeout processes for clinical studies and trials in the Division of Surgical Oncology. 
• Maintains knowledge of institutional, state, federal and international guidelines that govern clinical research. Educates new Faculty and clinical research staff in the Division of Surgical Oncology generally during the on-boarding and early establishment processes. Communicates changes on regulations and guidelines to staff. 
• Responsible for communicating the Institution policies and procedures to research support staff and Principal Investigators. 
• Provides guidance and timely responses to requests from faculty seeking to participate in industry and federally funded clinical studies through coordination of planning/feasibility meetings, coverage analysis, budget development, internal compliance approval oversight, and contract negotiations. 
• Manages regulatory submissions and group interactions in the Cancer Center Clinical Trials Support Unit (CTSU) to ensure interdepartmental collaboration and compliance with P30-mandated reporting requirements, including protocol development and adherence in OnCore. 
• Supports the Director, Research Operations overseeing payroll and salary administration in the clinical research area and assists with the implementation of organizational and operational decisions.
• Directly supervises a growing team of clinical research personnel including all levels of Research Coordinators and research staff. 
• Drafts HR position descriptions and recruits additional research staff personnel for the Office of Surgical Research. 
• Ensures that all internal personnel activities meet College and organizational objectives in training, recruitment, equal pay, equal opportunity, transfer, and promotion. 
• Establishes and implements quality assurance and quality control measures/oversight to ensure adherence to College’s policies and regulatory standards. 
• Maintains up-to-date and accurate records and reports of clinical research, and monitors research metrics as requested. 
• Contributes to quarterly/biannual/annual metrics reports. 
• Performs other job-related duties as assigned.

Minimum Qualifications

• Bachelor's degree.
• Five years of relevant experience.

Preferred Qualifications

• Master's degree.  
• Five or more years of clinical research experience. 
• Knowledge regarding global requirements regarding Clinical Trials requirements and negotiations.
• Strong negotiation, planning, strategizing, mentoring, monitoring, scheduling, diplomacy, critiquing, analysis, and problem-solving skills.
• Excellent written and verbal communication skills, to clearly and concisely present information.