Study Start-Up Manager
Our growing Protocol Activation Team has an exciting opportunity for a Study Start-Up Manager. You will lead the activation of clinical research studies, coordinating with other Clinical Research Administration teams to ensure that the Center's goals for Time to Activation are met. Join us today and help make a difference every day!
Direct and lead protocol activation for assigned protocols ensuring customer focus, activation goals and accountability.
Collaborate and communicate effectively with all internal and external stakeholders
Assess complex protocols quickly to plan an effective activation pathway and manage all submissions to departmental/scientific review committees, sponsors, and IRB to meet time to activation expectations while ensuring high quality.
Ensure that all protocol documents are clear and follow Federal Regulations and Institutional policies
Writes informed consent forms and other patient facing protocol documents and negotiates documents with external industrial sponsors as necessary
Ensure Principal Investigators and Clinical Research Managers (and others as needed) are notified of protocol status throughout the entire process through metrics, dashboards, and reporting.
Evaluate internal protocol activation requirements to determine when a protocol can be opened to patient/participant accrual
4-7 years of clinical research experience.
Experience with Human Subjects Protection, GCP and GMP standards, FDA/EMA requirements, Quality Standards and Systems.
Experience working with sponsors and protocol development.
Monday - Friday, 9 AM - 5 PM. This role is hybrid, which means that the individual will be required to come on site up to 2 times per month.
We believe in communication, openness, and thinking beyond your 8-hour day @ MSK. It’s important to us that you have a sense of impact, community, and work/life balance to be and feel your best!
Competitive compensation packages | Sick Time | Generous Vacation+ 12 holidays to recharge & refuel | Internal Career Mobility & Performance Consulting | Medical, Dental, Vision, FSA & Dependent Care | 403b Retirement Savings Plan Match | Tuition Reimbursement | Parental Leave & Adoption Assistance | Commuter Spending Account | Fitness Discounts &Wellness Program | Resource Networks | Life Insurance & Disability | Remote Flexibility
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.
Applications for the Study Start-Up Manager position can be sent to: https://externaltalent-mskcc.icims.com/jobs/61060/study-start-up-manager-%28pam%29/job?mode=view&mobile=false&width=759&height=500&bga=true&needsRedirect=false&jan1offset=-300&jun1offset=-240