Clinical Research Monitoring Manager
Job Posting Number: 22334
New York, NY
May 12, 2018
At Memorial Sloan Kettering (MSK), we’re not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we’re driving excellence and improving outcomes.
For the 28th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker’s Healthcare list as one of the 150 Great Places to Work in Healthcare in 2018, as well as one of Glassdoor’s Employees’ Choice Best Place to Work for 2018. We’re treating cancer, one patient at a time. Join us and make a difference every day.
Reporting directly to the Director, Clinical Research Quality Assurance (CR QA), the Clinical Research (CR) Monitoring Manager oversees and actively manages the daily operations of MSK’s centralized Clinical Research Monitoring Program.
- Ensure that through monitoring and oversight the clinical research program at MSK adheres to all federal regulatory requirements and ICH (International Center for Harmonization) guidance on Good Clinical Practice (GCP).
- Ensure that participants/patients are treated in accordance with the protocols.
- Manage and oversee the quality of MSK’s Investigator-initiated Portfolio through monitoring, establishes consistency and conformity with Multi-Site Compliance Unit monitoring responsibilities.
- Evaluate real-time feedback from Industrial Sponsors and escalate , as appropriate, emergent protocol compliance, data quality or process concerns.
- Develop analytical methods to track monitoring results and findings to measure impact and success.
- Manage a real-time eligibility verification of participants/patients enrolled in MSK clinical trials through CTMS (Clinical Trials Management System).
- Work with CRA Leadership and CR Operations Leaders to provide real-time feedback, process improvement and common trends identified through Monitoring to improve overall quality.
- Bachelor’s degree with at least 7 years of clinical research experience.
- 4 years of management/leadership experience.
- Human Subjects Protection Certification, GCP Certification, GMP Knowledge, FDA/EMA requirements, Quality Standards and Systems experience.
- Communication Skills: The ability to develop, facilitate, and orchestrate effective communication with all members of MSK; responsible for the writing, preparing and educating staff on clinical research procedures and processes. Individual must be able to communicate effectively with all levels of staff including clinical staff (investigators, nurses etc), administration, research and clerical support staff, and Institutional Leaders as well as external sponsors. Excellent oral and written communication skills are required.
- Federal Regulations: Must have an advanced comprehensive knowledge and understanding of the regulations pertaining to human research protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations) and Health Insurance Portability and Accountability Act (HIPAA).
- Information Management Skills: The ability to communicate, explain, interpret, share and present information to employees, management and clinical staff and patients at MSK as well as appropriate external contacts.
- Analytical Skills: A strong ability and understanding on how to collect, analyze, interpret and prepare data for presentation (i.e., written, tabular and graphical formats). Excellent problem-solving ability. Ability to analyze situations, draws conclusions, make recommendations and convey information in a timely and proficient manner. Strategic thinker.
- Time Management Skills: The ability to set priorities among several tasks simultaneously and meet established deadlines. Ability to manage multiple large scale development projects simultaneously. Ability to guide staff to ensure programmatic activities adhere to established time frames and deadlines.
- Administrative Skills: The ability to plan, organize, facilitate and lead meetings, to develop programs, to manage research projects and to prioritize work across several services/departments is essential.
- Computer Skills: Proficiency in use of computers and software such as database management, spreadsheet, word processing and graphics applications. Knowledge of mainframe systems utilized at MSKCC is essential.
MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
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