Remote Clinical Study Manager

Summary

Join a team passionate about precision medicine and advancing the healthcare industry. As a Clinical Study Manager (CSM), you will be responsible for planning, executing, monitoring, and closing observational/non-interventional studies. You will direct the financial and operational aspects of the project, including acting as the primary liaison to clients, project team, and vendors.

Requirements

• University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology)
• Minimum of five (5)+ years relevant clinical research experience in a combination of research site, life sciences company or CRO
• Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
• Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
• Demonstrated ability to be self-directed
• Working knowledge of project finance
• Familiar with concepts commonly incorporated non-therapeutic studies: risk-based monitoring, quality of life and patient-reported outcomes, health outcomes etc
• Excellent communication, planning and organizational skills

Responsibilities

• Responsible for executing Tempus’s observational trials in compliance with quality standards (ICH/GCP, Global Regulations, and Tempus policies and procedures)
• Act as primary point of contact for clients. Anticipate client needs and proactively resolve issues as necessary
• Lead cross-functional teams and third parties/vendors to ensure effective teamwork and communication
• Manage project deliverables including timeline, quality, scope, and cost
• Maintain study management system(s)
• Develop and maintain project plans
• Primary contact for assigned sites and build positive relationships with investigators and site staff
• Complete monitoring visits and/or oversee Clinical Research Associates, as applicable
• Manage participant recruitment, sample reconciliation, data entry to safe-guard project endpoints
• Responsible for the completeness and quality of the Trial Master File
• Provide temporary coverage/back-up for additional observational studies as required
• May involve overnight travel

Preferred Qualifications

• Experience with observational/non-interventional studies, registries, comparative effectiveness studies, etc
• Prior experience working for both a sponsor/life science company and a CRO
• Previous clinical monitoring experience