1. Directs and oversees the clinical trial operation function for a Yale Cancer Center, Clinical Trials Office oncology disease group. Creates functional strategies and specific objectives for the assigned oncology disease group portfolio and develops budgets, policies and procedures to support the functional infrastructure. 2. 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. 3. Designs and implements process improvement initiatives to meet goals and objectives. 4. Responsible for recruiting, hiring, career development, performance evaluations, disciplinary actions, and day-to-day supervision of the clinical research professionals (clinical research managers, clinical trials project managers, data coordinators, clinical research coordinators, and clinical research nurses. 5. Establishes priorities with appropriate timelines for to ensure efficient and effective operations. Deploys resources among teams in collaboration with faculty oncology disease group leaders. 6. Partners with the CTO Quality and Education unit to ensure proper education and training of clinical research professionals (data coordinators, clinical research coordinators, clinical research nurses and clinical research managers) as it pertains to clinical facing responsibilities. In partnership with the CTO Quality and Education unit, develops, implements, and evolves Oncology specific role-based curriculum for new employees. 7. Ensures full compliance of clinical research operations within the span of authority of the position. Prepares responses to audit findings. Designs, implements, and monitors corrective action plans. 8. 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. 9. 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.

Required Skill/ability 1:  Demonstrated mastery of the phases of clinical trials, and the regulatory, administrative, and operational functions necessary to support the clinical research study life cycle in a safe and compliant manner. Provide leadership and promote collaboration with staff, faculty, senior management, and other team members including those geographically dispersed.

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. 

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. Demonstrated experience auditing and coordinating audits of systems and practices to ensure quality and regulatory compliance. 

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 5:  Demonstrated communication, leadership and team building skills: evidence of this should include resource management, effective problem solving, conflict resolution, motivating others as individuals and as groups, and planning, organizing, and directing the activities of others.

Preferred Education:  Master's degree in a health-related discipline, or other related field. Demonstrated experience with oncology clinical trials strongly preferred.

Work Week:  Standard (M-F equal number of hours per day)

Posting Position Title:  Assistant Director, Clinical Trials Operations

University Job Title:  Assistant Director, Clinical Trials Operations

Preferred Education, Experience and Skills:  Master's degree in a health-related discipline, or other related field. Demonstrated experience with oncology clinical trials strongly preferred.

Bachelor's degree in a health-related discipline and a minimum of eight (8) years of demonstrated clinical research experience with four (4) years of demonstrated clinical trials research operations experience required. Three (3) years of demonstrated supervisory experience required.

Return to Search Results