
Job Description
Responsible for the oversight and execution of study start-up and maintenance for all assigned projects in accordance with applicable regulatory guidelines/requirements, Tempus Compass Standard Operating Procedures (SOPs), and project specific plans. As an integral member of the study team, will work cross-functionally to execute on the strategy and report on progress related to project timelines and goals to the Sr. Manager, Regulatory Operations. As a manager, may be responsible for oversight of direct reports, or mentoring and coaching colleagues to ensure overall project efficiency.
Job Responsibilities:
• Efficiently manages and successfully executes all aspects of study start-up and maintenance which includes but is not limited to initial site outreach to begin the CDA process, feasibility, regulatory packet creation and dissemination to selected sites, site outreach involving relationship building and helping to ensure study timelines are met, etc.
• Supports Sr. Associate as needed with ongoing regular outreach to clinical sites to facilitate essential document collection and other start up and maintenance related ...
The Real Dill ☘️
Drug development is hard - Big Pharma wouldn't be a $1 TRILLION+ industry if it wasn't. From end to end development, some estimates show nearly a decade of work and $1B of investment is needed to bring a single drug to market, not to mention the incredible attrition rate of molecules that don't pass muster to progress from preclinical to Phase 1/2/3 clinical trials and regulatory approval. Three of the biggest challenges facing the drug development industry in increasing the success rate of bringing drugs to market are the focus of Tempus Labs: drug discovery (finding new molecules to develop), clinical trials (verifying the usage and viability of turning molecules into medicines) and diagnostics (finding the right patients to take each highly complex, specialized drug being developed). It makes sense that these processes could be opportunities for artificial intelligence to accelerate the process - helping doctors understand disease progression by finding the right patients for a trial, etc. Startups in this space are raising ludicrous amounts of money (Tempus Labs itself has raised over $1B) which is a startling contrast to the adjacent digital health space where companies are striving for overall valuations in the $1B ballpark...it's a different game, with different players, and, in some ways, even more competitive. (September 2023)
Jon Lee, PT, DPT, OCS, FAAOMPT, MBA
Pickle co-founder
About Tempus Labs
Advancing precision medicine through the practical application of artificial intelligence in healthcare.
MissionFor each patient to benefit from the treatment of others who came before by providing the healthcare industry tools that learn as we gather more data.
Wow FactorClaims >90% of the top 20 Pharma companies partner with Tempus
Company benefits
- 🔐 Health insurance
- 🦷 Dental
- 👀 Vision
- 🤕 Short-term disability benefit
- 🐣 Maternity/paternity leave
- 🐶 Pet benefits
- ✈️ Travel stipends
- 💰 Life insurance
Pickle is not affiliated with listed companies unless otherwise noted.
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