In order to effectively and efficiently accommodate the growth and manage the complexity of clinical trials at MSK, Clinical Research Administration has created the new role of Director - Clinical Research Quality Assurance that will focus on clinical research quality and regulatory compliance.
In this visible role, you will:
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).
Plan for and oversee all internal and external auditing and monitoring across 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 a strategic leader within the organization and serve as primary liaison with clinical department leadership to efficiently and effectively meet the clinical research goals of MSK.
Creates formal networks with key decision makers and serves as external spokesperson for the organization.
Works on significant and unique issues where analysis of situations or data requires an evaluation of intangible variables and may impact future concepts, processes, products or technologies.
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.
10 years of clinical research experience, with at least four (4) years developing andmanaging a formalClinical 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 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.
Additional Salary Information: Salary is commensurate with skills and experience.
Memorial Sloan Kettering Cancer Center — the world’s oldest and largest private cancer center — has devoted more than 130 years to exceptional patient care, innovative research, and outstanding educational programs. Today, we are one of 47 National Cancer Institute–designated Comprehensive Cancer Centers, with state-of-the-art science flourishing side by side with clinical studies and treatment.
The close collaboration between our physicians and scientists is one of our unique strengths, enabling us to provide patients with the best care available as we work to discover more-effective strategies to prevent, control, and ultimately cure cancer in the future. Our education programs train future physicians and scientists, and the knowledge and experience they gain at Memorial Sloan Kettering has an impact on cancer treatment and biomedical research around the world.
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.