Site Operations Manager
With the advent of genomic sequencing, we can finally decode and process our genetic makeup. We now have more data than ever before but providers don't have the infrastructure or expertise to make sense of this data. We're on a mission to combine our next-generation sequencing and structured clinical data analytics capabilities with an innovative clinical trials network model to accelerate the pace of immuno-oncology research.
Do you find the slow pace of drug development unacceptable? Are you ready to use cutting-edge technology to accelerate the completion of cancer clinical trials? Are you passionate about improving patient access to new treatment options? We are looking for experienced clinical trials professionals who have innovative ideas and want to put them into action.
What You’ll Do
- Partner with site staff to assess their research capabilities, needs, and limitations
- Work with site research, administrative, and legal staff to join the research network and begin matching their patients to molecularly targeted trials
- Utilize your knowledge of clinical trial operations, Good Clinical Practice, and drug development to select, qualify, and partner with research sites using an innovative just-in-time site activation model
- Collaborate with site physicians, administrators, legal teams, financial stakeholders, EMR/IT experts, pharma and CRO partners to plan and execute rapid site activation
- Design, develop, implement and continuously improve robust best practice processes to grow and manage site participation in a rapidly expanding precision medicine oncology research network
- Utilize your emotional intelligence to develop and nurture excellent working relationships with sites, sponsors, CROs, and internal stakeholders to proactively identify and solve problems quickly and effectively
- Act as a subject matter expert for clinical trials while working with industry leaders at Tempus in bioinformatics, molecular pathology, big data analytics, software engineering, product development, translational research, and business development
- Create innovative tactics, processes, tools, systems, and strategies to continually accelerate the completion of cancer clinical trials
- Travel required (roughly 30% - will vary)
- Bachelor's Degree and 5-10+ years of experience working with complex clinical trials from a site, sponsor or CRO perspective
- Understanding of FDA regulations, GCP, drug development processes, clinical site, and trial operations.
- Exceptional customer service skills and strong interpersonal and problem solving skills
- Proven track record of setting and achieving high personal standards of performance
- Highly organized and systematic, superb attention to detail, and ability to complete tasks with a high degree of accuracy and an eye towards process improvement
- Flexible and adaptable; ability to work independently in a fast-paced environment
- Oncology experience
- Experience with rapid site activation
- Deep understanding of study start up, selection, and feasibility