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29 days old

Clinical Program Manager

Kelly Services
Sunnyvale, CA 94086
**Clinical Program Manager**


**Job Description**


The Clinical Project Manager will manage 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.


**ESSENTIAL JOB RESPONSIBILITIES:**


+ Manages clinical operational plan, and incorporates the study and scientific plan

+ Ensures the selection of qualified clinical trial sites

+ Develops study related documents and overall direction for the clinical sites to establish protocol development.

+ Negotiates all aspects of clinical trial agreements Monitors clinical trial sites for compliance and performance

+ Ensures compliance with good clinical practices GCPs and regulatory guidelines

+ Recommends and implements innovative process ideas to impact clinical trials management

+ Manages clinical budget and develops contingency plans for clinical trials

+ Oversees Operations staff, both regular and contract staff, and manages all aspects of clinical operational plan

+ Responsible for managing full scope of study

+ Review the data management and statistical plans and provide input for execution of plan elements

+ Assure data quality by planning data review and ongoing process control checks

+ 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

+ Effectively communicate changing priorities, within the cross-functional and Clinical teams, as studies progress


**TRAINING RESPONSIBILITIES:**


**REQUIRED**


Complete all assigned and required training satisfactorily and on time.


**MINIMUM REQUIREMENTS:**


**Education and Experience in years :**


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


**Knowledge and skills:**


Excellent organizational and project management skills Strong leadership skills, self-motivated, adaptable to a dynamic environment Strong oral and written communication skills; strong technical writing skills


Working knowledge of FDA regulatory requirements related to clinical research


Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results


Ability to problem solve and delegate appropriate tasks to team members


Able to collaborate effectively with the study team, cross-functional team members, and external partners Travel requirements up to 20 in non-pandemic times


**PREFERRED REQUIREMENTS:**


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


The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.


For immediate consideration, email resume directly to the recruiter: Clara.Cresswell@KellyScientific.com


**\#TJP2021_SPEC**


**\#ACRP**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-08-30 Expires: 2021-09-30

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Clinical Program Manager

Kelly Services
Sunnyvale, CA 94086

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