Study Start-Up Manager at Tempus
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 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 an experienced Study Start-up Manager, possessing innovative ideas and a desire to put them into action.
What you’ll do:
- Collaborate with pharmaceutical partners/CROs to employ an innovative approach to rapid study start-up.
- Utilize knowledge of clinical trial development and study start-up to get a portfolio of trials ready for our network of community sites.
- 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 (will vary by project)
- Bachelor's Degree and 5-10+ years of experience in working with complex clinical trials from a site, sponsor or CRO perspective.
- Understanding of FDA regulations, GCP, study start-up, clinical trial agreements, trial budgets, IRB submission and site 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