Clinical Research Manager - Multicenter Office, Multi-Site Compliance

We are seeking a Clinical Research Manager (CRM) in the Multicenter Office, Multi-Site Compliance . The CRM serves as an integral member of the research team and will oversee external site activation of MSK investigator-initiated multicenter trials and ensure compliance of policies and procedures to provide the highest quality management of clinical research trials. The CRM serves as an integral member of the research team and will own the daily operations and activities of the program.

This is an excellent leadership opportunity within our growing clinical research team.

• Staff Management: You will supervise the training/development and performance management for direct and indirect reports throughout the service.
• External Site Activation: Lead aspects of activating protocols at external sites, including but not limited to reviewing external site consents, preparing and negotiating subsite budgets, collaborating on sub-contract development and execution and addressing comments and/or questions.
• Financial Management: Work closely with the appropriate partners, forecast trial resource needs, and assess staffing resource needs for program and senior leadership.
• Clinical Trial Reporting: Generate protocol portfolio status reports for key partners. Implement solutions for streamlining and accelerating the external site activation process.
• Quality Assurance: Review and provide feedback and assess feasibility for MSK investigator- initiated multicenter trials. Conduct amendment reviews and provide feedback prior to IRB submission. Provide quality assurance reports of pending amendment approvals and continuing review approvals at external sites. Communicate and ensure compliance with company policies and procedures, quality standards and improvement initiatives.

• At least 4 years of clinical research experience.
• 2 years or more of direct staff management experience.
• Thorough knowledge of Good Clinical Practice (GCP) guidelines, Human Subject Protection, clinical trial design, regulatory processes, and clinical development process required.
• Therapeutic and Oncology Research experience strongly preferred.
• Budget development experience strongly preferred.
• Effective written/verbal communication and oral presentation skills required. Excellent interpersonal, leadership, decision-making and issue resolution skills are essential.