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Head Of Clinical Operations
Company | PicnicHealth |
Address | United States |
Employment type | FULL_TIME |
Salary | |
Category | Software Development |
Expires | 2023-07-26 |
Posted at | 10 months ago |
San Francisco, CA / Remote
- Building, scoping and leading investment cases to support future growth of the team and business
- Work closely with CROs and other third-party vendors to provide oversight and ensure study success
- Helping to shape new to market trial offerings in partnership with product and commercial teams internally and sponsors, vendors and CROs
- Partnering with Regulatory team to define requirements upfront and ensure that solutions meet all legal, regulatory and customer requirements
- Collaborating with Commercial and Product Marketing teams to understand and assess market opportunity and incorporate customer feedback to evolve offerings
- Responsible for study execution, implementation and success by working with cross functional collaborators and managing timeline and resources
- Building and leading a team focused on building and shaping scalable strategy and operations for traditional site-based, decentralized and hybrid studies
- Be an internal and external subject matter expert on Clinical Operations needs and requirements
- 2+ years experience working in a startup or other high-growth environment
- Expert knowledge of regulatory requirements, including FDA and ICH/GCP regulations and guidelines including the use of real world data in regulatory submissions
- Experience managing teams of site-facing personnel including training and mentorship
- A BA/BS degree or higher, preferably in life sciences
- Have strong interpersonal skills, able to build relationships both internally and externally with stakeholders at various levels
- Expertise overseeing traditional site-based studies and innovative decentralized or hybrid trials, including interacting directly with sponsors, sites (physical and virtual), vendors, and CROs
- Understanding of how real world data can be used to supplement traditional interventional studies
- Have strong communication skills; you will be sharing progress to stakeholders regularly
- 7-10 years clinical trial project management experience in the pharmaceutical (or related) industry
- Experience integrating novel technology at participating sites and ensuring effective rollouts by CROs
- Free PicnicHealth account
- Flexible time off
- 401k plan
- Competitive salary
- Equipment and internet funds for home office set up
- Family friendly environment
- Comprehensive benefits including above market Health, Dental, Vision
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