| Company Overview:|
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 27th 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 2016, as well as Glassdoor’s annual Employees’ Choice Awards 2016. We’re treating cancer, one patient at a time. Join us and make a difference every day.
In an effort to accommodate the growth and complexity of clinical trials at MSK, Clinical Research Administration has redesigned its infrastructure to ensure a more cost-effective and streamlined business process. In doing so, several key leadership roles have been developed, including the Director - Clinical Research Quality Assurance.
Report directly to the VP - Clinical Research Compliance.
Direct and actively manage the development and daily operations of MSK’s centralized clinical research quality assurance program.
Ensure that the clinical research program, including investigational product development, adheres to all federal regulatory requirements and ICH (International Center for Harmonization) guidance on Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).
Plan for and oversee all internal and external audits across clinical research program and manufacturing facilities to ensure compliance with institutional, federal and other applicable clinical research regulations.
Plan for and oversee all internal and external monitoring across the clinical research program and manufacturing facilities to ensure compliance with institutional, federal and other applicable clinical research regulations.
Ensure top quality research is performed by tracking essential metrics, evaluating risks, crafting trend reports and implementing policies and procedures for improvement of the entire MSK clinical research portfolio of clinical trials including industrial, cooperative group, investigator initiated and externally peer reviewed trials.
Act as primary liaison with clinical department leadership to efficiently and effectively meet the clinical research goals of MSK.
A strategic thinker who looks ahead to future possibilities and translates them into breakthrough strategies.
Knowledgeable about business and the marketplace and able to apply this knowledge to advance the organization's goals.
A good decision-maker, with proven success at making timely decisions that keep the organization moving forward.
A provider of work directives, delegating responsibilities as necessary and removing obstacles in order to get work done.
Effective at building formal and informal networks inside and outside the organization to further departmental and institutional goals.
7-10 years of clinical research experience, with at least two (2) years developing and managing a formal Clinical Research QA program.
4-7 years of management/leadership experience.
Experience related to Human Subjects Protection (including 21 CFR and 45 CFR 46 of the US Code of Federal Regulations), GCP and GMP standards, FDA/EMA requirements, Quality Standards and Systems, and HIPAA preferred.
Strong communication skills including the ability to develop, facilitate, and orchestrate effective communication with all members of MSK, including the responsibility for writing, preparing and educating staff on clinical research procedures and processes.
Excellent problem-solving ability including a strong ability and understanding on how to collect, analyze, interpret and prepare data for presentation (i.e., written, tabular and graphical formats).
Superior time management, administrative and computer skills.
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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