Our growing Protocol Activation Team has an exciting opportunity for a Manager, Study Start-Up. 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!

You Will:

• 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

You Have:

• 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.

Hours:

• 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. Its important to us that you have a sense of impact, community, and work/life balance to be and feel your best!

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