Directs and oversees the clinical trial operation function for a Yale Cancer Center, Clinical Trials Office disease team portfolio. Creates functional strategies and specific objectives for the assigned disease team portfolio and develops budgets, policies and procedures to support the functional infrastructure. Provides strategic input to leadership related to short and long-term planning for the Cancer Center Clinical Trials Office. Develops and implements short and long-term objectives for assigned portfolio related to productivity, compliance, communication and patient satisfaction. Designs and implements process improvement initiatives to meet goals and objectives. Manages and directs the ongoing and day to day operations of the assigned disease team portfolio staff, consisting of Clinical Trials Team Managers, Clinical Research Nurses, Clinical Research Coordinators, and Clinical Research Assistants. Establishes priorities with appropriate timelines for to ensure efficient and effective operations. Deploys resources among teams in collaboration with faculty DART leaders. Ensures the competency of staff across each disease team through effective onboarding, and ongoing training programs, coaching and mentoring. Ensures full compliance of clinical research operations within the span of authority of the position. Prepares responses to FDA audit findings. Designs, implements, and monitors corrective action plans. Drives operational changes to achieve best in class operations throughout the organization based on the findings of internal or external auditors, confirming full compliance of requirements of Clinical Trials Reporting Program (CTRP). Manages and directs the data management functions inherent to oncology clinical research of assigned disease team portfolios, including effectively and efficiently collaborating with external sponsors on requisite data collection platforms. Oversees the activities necessary to ensure effective and timely activation of clinical trials within disease team portfolio from stage of protocol concept through obtaining open to accrual status. Utilizes data to effectively monitor the process for protocol activation.
Preferred Education: At least seven years of oncology clinical research experience, of which a minimum of five years must be in a management role, supervising oncology clinical research.
Preferred Education, Experience and Skills: At least seven years of oncology clinical research experience, of which a minimum of five years must be in a management role, supervising oncology clinical research.
Posting Position Title: Assistant Director, Clinical Trials Operations
Required Skill/ability 3: Ability to conduct periodic reviews of the clinical trial portfolio and evaluate the research infrastructure to ensure best use of resources and clinical trial accrual. Experience auditing and coordinating audits of systems and practices to ensure quality and regulatory compliance.
Work Week: Standard (M-F equal number of hours per day)
University Job Title: Assistant Director, Clinical Trials Operations
Required Skill/ability 1: Demonstrated clinical research skills and specialized knowledge of the unique needs of patients undergoing treatment in oncology clinical trials. Knowledge of the drug development process, and prevention, detection, treatment, and clinical trial designs.
Required Skill/ability 4: Understanding of clinical research operations. Ability to assist with achieving financial and operations targets for assigned research areas through participation in program planning, budget development and development of operational practices.
Required Skill/ability 2: Proven ability to manage and evaluate orientation, education and professional developmental needs for research staff using the CFR, GCP, ICH, protocol requirements, and research professional resources with the objective of developing and maintaining high functioning of clinical research experts.
Bachelors Degree In related field and five years of related experience.
Internal Number: 58636BR
About Yale University
Yale University is an American private Ivy League research university located in New Haven, Connecticut. Founded in 1701 in the Colony of Connecticut, the university is the third-oldest institution of higher education in the United States.