Full Job Description
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.
The Senior Protocol Activation Manager leads the activation of clinical research studies and supervises the day-to-day operations of their team. This role coordinates with other Clinical Research Administration teams to ensure that the Center goals for Time to Activation are met. This position requires the ability to interpret complex research protocols quickly and discern the explicit and implicit items needed for activation. This position requires the ability to navigate and champion protocols through a complex system involving Finance, Contracts, Nursing, Clinical Research Operations, external/industrial research sponsors and all clinical departments involved in human research studies. This role manages activation for critical high profile/value protocols that require more advanced expertise, nuance and trouble-shooting. This is a key role in both maintaining and improving the user experience and integrating optimal protocol activation functioning. This position works closely with other Senior Protocol Activation Managers to ensure consistency and work load balance of the teams.
Bachelor’s degree with at least 7 years of clinical research experience; oncology experience strongly preferred with Human Subjects Protection, GCP and GMP standards, FDA/EMA requirements, Quality Standards and Systems experience.
At least 4 years of management experience.
Demonstrated written 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, processes and research protocol documents.
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.
Experience in a regulated environment – 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).
Demonstrated 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.
A strategic thinker.
Excellent collaboration and team building skills – The ability to develop, facilitate, and orchestrate effective communication with all members of MSK and within the Protocol Activation and HRPP Unit; responsible for the writing, preparing and educating staff on clinical research procedures, processes and research protocol documents.
Ability to manage at least 20 protocols under activation plus team assignments simultaneously.
Ability to manage multiple large scale development projects simultaneously.
Ability to guide staff to ensure programmatic activities adhere to established timeframes and deadlines
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.
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.