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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:
Responsible for the planning and implementation of clinical operations deliverables, primarily site management and clinical monitoring of assigned projects 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. Manages and contributes to continuous process and quality improvement within the Clinical Operations department.
Independently serves as Clinical Trial Lead and/or Strategic Oversight (as assigned) on complex studies, applying and providing guidance to clients and team members on best practices tailored to the applicable project, patient population, investigational product, and client. Responsible for coaching/mentoring and supporting the CRA team and representing the clinical operations function to the client. Expected to build positive rapport with internal and external project teams and site staff.
Serves in a line management and leadership role with minimal supervision and guidance.
Job Responsibilities:
Tasks may include but are not limited to:
Lead/Perform independently, with minimal guidance and oversight:
Clinical Trial Lead Responsibilities:
- Manage clinical operations deliverables, including timeline, quality, scope, and financials.
- Develop plans, monitor resource allocation, and ensure clinical site management and monitoring are delivered with quality and efficiency.
- Proactively identify risks and escalate to the Project Manager and other appropriate functional leads.
- Together with the Project Manager, ensure transparent communication internally and externally regarding study progress and issues.
- Contribute to Risk, Action, Issue, and Decision (RAID) tracker, including the Risk Assessment Categorization Tool (RACT).
- Anticipate client needs and proactively resolve issues as necessary.
- Develop and maintain project-specific clinical operations plans (e.g., Clinical Monitoring Plan, Cohort Management Plan, Recruitment Plan).
- Develop and maintain project-specific clinical operations reference materials and tools, including study-specific forms and logs.
- Develop training materials and conduct training for the clinical operations team throughout the project lifecycle.
- Provide operational oversight for site and CRA deliverables and key performance indicators such as site activation, subject recruitment, site monitoring visits, data currency, and quality.
- Manage CRA resourcing, site assignments, visit schedules, and serve as the initial point of contact for clinical operations and monitoring issues.
- Review and approve site monitoring visit reports; monitor and track related metrics for compliance with the Clinical Monitoring Plan and Tempus Compass SOPs.
- Conduct monitoring visits, co-monitoring visits, assessment visits, and/or team training as necessary.
- Support inspection-ready Trial Master File (TMF) for the duration of projects; perform maintenance tasks such as filing and periodic quality reviews of clinical operations documents, and prepare for audits and archiving.
- Maintain project-related data in the Clinical Trial Management System (CTMS), project-specific SharePoint sites, and/or other tracking spreadsheets as applicable.
- Support the creation of the Investigator Site Files (ISF) and/or Site Reference Manual as applicable.
- Coordinate the distribution of clinical trial materials and ensure inventory is adequate for the overall study.
- Assist Regulatory Affairs and Investigation Services (RAIS) with secondary review and QC of essential documents such as the Informed Consent or Clinical Trial Agreement.
- Assist the Project Manager with processing of clinical investigator payments and other financial items as required.
- Perform other duties as assigned.
- May involve overnight travel.
Clinical Operations Department Responsibilities:
- Provide strategic oversight for assigned projects or portfolios.
- Line-manage Clinical Operations personnel, including interviewing, selection, terminations, professional development, and performance appraisals.
- Contribute to management of department-level metrics, quality, and risks.
- Develop and review department-level SOPs, Work Instructions, and other guidance documents.
- Identify and manage implementation of department-level initiatives, growth, and training needs.
- Contribute to business development activities, including meeting prospective clients, proposal and budget development, and bid defense meeting preparation and presentations.
- Perform other duties as assigned.
- May involve overnight travel.
Demonstration of 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 seeks 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 (e.g., nursing, medical, or laboratory technology).
- Minimum of 13+ years of relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience.
- Minimum of 10+ years in Clinical Trial Lead/Manager or Clinical Project Manager roles, or relevant clinical operations experience at a CRO, biotech, or pharma company.
- Oncology clinical trials or oncology clinical experience.
- Early-phase clinical trial experience in oncology.
- Prior experience working on global clinical trials in a Clinical Operations role.
- Effective at integrating global clinical operations teams and leading them through challenging and complex situations.
- Experience overseeing a program or portfolio of projects.
- Excellent communication, planning, decision-making, risk management, negotiation, conflict management, and time management skills.
- Experience in the full study lifecycle.
- Experience presenting and negotiating with senior internal and client leadership.
- In-depth knowledge of clinical trials; ability to see the bigger picture and prioritize critical elements of success.
- Working knowledge of ICH Guidelines and GCP, including international regulatory requirements for clinical development programs.
- Demonstrated ability to handle multiple competing priorities and utilize resources effectively.
- Demonstrated ability to build rapport with team members and clients; customer-service oriented.
- Excellent written and verbal communication skills.
- Excellent organizational skills, attention to detail, and ability to handle multiple competing priorities within tight timelines.
- Able to anticipate needs and follow through on tasks.
- Proficient in Microsoft Word and Excel.
Preferred Qualifications:
- Prior experience working for both a Sponsor company and a CRO.
- Prior experience in a Clinical Research Associate-related role at a CRO, biotech, or pharma company.
- Direct line management experience.
- Leadership position experience.
- Working understanding of the drug development lifecycle within oncology products.
#LI-SH1 #LI-Hybrid
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.
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.
