Disease Team Project Manager - Cancer Center - 140391

The Moores Cancer Center (MCC) is one of just 53 NCI-designated Comprehensive Cancer Centers in the United States and the only one in San Diego County. As a consortium cancer center, it is a collaborative partnership between the UCSD: encompassing 28 departments, 6 schools (School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, School of Public Health, Jacobs School of Engineering, School of Biological Sciences & the School of Physical Sciences), UCSD Health oncology hospitals and clinics; the basic and public health research and outreach of San Diego State University (SDSU), and the basic and translational research of the La Jolla Institute of Immunology (LJI). These various programs and units are all dedicated to fulfilling the Moores Cancer Center's mission of reducing cancer's burden. As such, it ranks among the top centers in the nation conducting the continuum of cancer research, providing advancedpatient care, and serving the community through outreach and education programs. As a top-ranking, future-oriented organization, we offer challenging career opportunities in a fast-paced and innovative environment. Moores Cancer Center follows a progressive philosophy ofcareer-path development for its employees including opportunities for cross-training, professional development, and progressive responsibility.

MCC's mission is to transform cancer care in our catchment area and beyond by driving exceptional scientific discoveries and innovations in prevention, detection, care, and training. MCC will make a global impact on improving health by reducing cancer burden through accelerateddiscovery and translation, compassionate and interdisciplinary care, education and community engagement, with the foundation of our core values - Excellence, Innovation and Risk-Taking, Collaboration, Diversity and Service.

The Clinical Trials Office (CTO) at UCSD's Moores Cancer Center administers many clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators.

Reporting directly to the CTO Associate Director, Clinical Operations, the Disease Team Project Manager supervises the day-to day activities of Clinical Research Coordinators, Data Coordinators and Long Term Follow-Up Coordinators of a specified Disease Team, including oversight and coordination of a large portfolio of complex oncology clinical studies. The incumbent is directly responsible for ensuring the team's adherence to protocols, appropriate management and distribution of the clinical research workload, ensuring CRC and Data Coordinator compliance with sponsor requirements and federal regulations overseeing auditing and monitoring visits. The Disease Team Manager is responsible for supervising, administering, and achieving operational goals and objectives for implementation within his/her specific Disease Team, and is directly responsible for the management of Disease Team staff.

The incumbent will also play a key role in leading and managing pre-study site selection visits (PSSVs) including liaising with all appropriate medical service units (e.g., Investigational Drug Service, Pathology, Radiology, etc.) for the conduct of the trial, managing quality assurance and quality improvement goals and objectives. Provides direct supervision typically to professionals or skilled technical employees. Functions as advisor to unit and administration.

Analyzes and resolves problems, interprets policies (e.g., fiscal management, HR, contracts and grants, resource management in defined areas) and demonstrates solid subject matter knowledge. Exercises judgment within defined procedures and policies to determine appropriate action. Supervises staff to assure accountability and stewardship of department resources (operational, financial, and human) in compliance with departmental goals and objectives.

Supervises staff responsible for working with departments, staff, patients and families in using clinical research techniques. May assume full responsibility for the research in delegated studies. Receives assignments in the form of objectives with goals and the processes by which to attain them. Supervises daily operations, and performance requirements. Has full oversight for staffing, performance management, and programmatic workflow of project.

Coordinates and oversees clinical trials from inception through completion, including approvals, initiation (site visit coordination), and start up procedures, protocol implementation, recruitment, screening, enrollment, data management, maintenance of subjects, writing publications and finalization of sponsor requirements. Oversees and analyzes complex databases. Compiles data reports as needed. Provides team, investigators, and clinical fellows with guidance regarding study design and logistics. Supervises staff work assignments and schedules to meet clinical research goals and timelines. Meets regularly with assigned staff to set goals and ensure objectives are being met. Supports patient recruitment plan development and execution, in conjunction with the Office of Community Outreach and Engagement (COE) and other Marketing, Communications and Business Development functions. Work with PIs and Director to plan and implement multiple phase I, II & III studies in assigned disease group. In conjunction with the Regulatory Affairs Manager and Start-Up Project Manager, monitor and ensure regulatory paperwork is submitted to the scientific committee for proposal review and monitor progress of regulatory approvals. Independently participate in onsite study monitoring visits, demonstrating proficiency in data management practices. Assure timely and accurate design and submission of reports, proposals and data collection instruments (instruments includes surveys and equipment for the study), with minimal protocol deviations and mitigations against delayed data entry

Supervises staff responsible for working with departments, staff, patients and families in using clinical research techniques. Participates in recruitment and orientation of new employees. Recommends salary actions, promotions, and terminations. Conducts necessary personnel actions for assigned staff including disciplinary actions. May assume full responsibility for the research in delegated studies. Receives assignments in the form of objectives with goals and the processes by which to attain them. Supervises daily operations, and performance requirements. Supervises staff work assignments and schedules to meet clinical research goals and timelines. Works with the Disease Team members to implement structural changes within the Disease Team and reassign projects as needed to maximize time efficiency within the constraints of limited resources. Trains and mentors staff to improve quality and quantity of work. Has full oversight for staffing, performance management, and programmatic workflow of project.

• Nine years of related experience, education/training, OR a Bachelor's degree in related area plus five years of related experience/training.

• Clinical Trial Professional certification from a professional society within one year in position.

• Broad knowledge of clinical or laboratory research and clinical research philosophy. Demonstrated ability to translate clinical research philosophy into business best practices in a trial setting.

• Demonstrated project management skills. Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.

• Demonstrated experience managing people with a wide range of educational backgrounds and skills. Demonstrated management and conflict resolution skills to effectively lead and motivate others. Demonstrated experience in training others in the field of research.

• Demonstrates good problem-solving and analytical skills. Creatively addresses complex or new problems.

• Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Ability to influence and negotiate.

• Excellent interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration.

• Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.

• Skills to work collaboratively with other cross-functional teams. Ability to interface and collaborate with other members of an extended study team. Ability to influence / persuade. Proven ability to effectively coordinate and integrate programs with others in division, department, and organization.

• Advanced degree.

• Employment is subject to a criminal background check and pre-employment physical.