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Clinical Program Manager, Diagnostics/IVD

2 months ago

Sunnyvale, United States Kelly Services Full time

Kelly® Science & Clinical is seeking a Clinical Program Manager for a fulltime, ldirect-hire position with a biotech company in California. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

 

The Clinical Program Manager is responsible for managing the overall operation of pre-clinical and clinical trials including project planning, budget, resource management and, if required, contract research organization management (CRO). Provides oversight, supervision, and mentorship to Clinical Operations staff.

 

This position is part of the Clinical Affairs department and will be located in Sunnyvale, Chicago, or Remote.

 

In this role, you will have the opportunity to:


Oversee Operations staff, both regular and contract staff, and manages all aspects of clinical operational plan
Develop study related documents and overall direction for the clinical sites to establish protocol development.


Manage clinical budget and develops contingency plans for clinical trials


Responsible for managing full scope of study
Develop and maintain effective communication across functions, including the Executive, R&D, Medical Affairs, Regulatory, Finance and Commercial teams; including regular reporting on adherence to timelines, milestones and budget, with recommendations for plan adjustments as needed


 

The essential requirements of the job include:

 


Bachelor’s degree in a scientific discipline or equivalent experience
5 to 7 years of clinical research experience within medical device (IVD preferred), biotech, or pharmaceutical
Working knowledge of FDA regulatory requirements related to clinical research
Strong oral and written communication skills; strong technical writing skills
Travel requirements up to 20% in non-pandemic times
At least 3 years of CRA experience and 1 years of study management experience
Experience with in vitro diagnostic clinical trials
Experience working with infectious diseases and/or oncology clinical trials





As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.Why Kelly® Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.






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