Clinical Study Manager

at  Tempus

PASSIONATE ABOUT PRECISION MEDICINE AND ADVANCING THE HEALTHCARE INDUSTRY?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus’ proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

SUMMARY:

The successful candidate will be responsible for independently planning, executing, monitoring and closing observational/non-interventional studies. The CSM role will direct the financial and operational aspects of the project, including acting as the primary liaison to clients, project team and vendors to ensure optimal quality, efficiency and communication. The CSM is responsible for the planning and implementation of clinical operations deliverables, primarily site management and clinical monitoring, of assigned project(s) to ensure delivery within specified budgets and timelines in accordance with applicable regulatory guidelines/requirements, Tempus Compass Standard Operating Procedures (SOPs) and project specific instructions. As a leader you will drive your projects forward, proactively, identifying and mitigating risks along the way.

MINIMUM QUALIFICATIONS:

• University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
• 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.

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

• 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