Clinical Study Manager
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.
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.
Job 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
Demonstration of Tempus Compass Values:
Consistently strives to demonstrate the following Tempus Compass values:
Recognizes that the team is always stronger than the individual
Seeks to inspire others by demonstrating consistently strong performance
Treats people with respect regardless of role or point of view
Listens well and seek to understand before reacting
Provides candid, helpful and timely feedback to colleagues
Demonstrates curiosity about and contributes effectively to areas outside of their specialty
Keeps the bigger picture in mind when making decisions
Never stops learning
Questions assumptions and offers suggestions for improvement
Focuses on results rather than process and seeks to minimize complexity when process is required
Identifies and addresses root causes, not symptoms
Demonstrates poise in stressful situations
Strives to always do the right thing
Questions actions that are incongruent with Tempus Compass values
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
#LI-SH1
#LI-Hybrid
Pay Range: $76,000 - $105,000
The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.
Additionally, for remote roles open to individuals in unincorporated Los Angeles – including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.