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14 days old

Director of Clinical Operations

Kelly Services
Charleston, SC 29409
Kelly Science & Clinical has a new direct hire opportunity for a Director of Clinical Operations with an established Clinical Research company in the Charleston, SC area.


Day-to-Day Responsibilities:


+ Lead and oversee clinical operations staff, CROs, FDA regulatory submissions, and external service providers within established timelines, budgets, and ICH/GCP regulations

+ Develop clinical trial designs with insight from KOLs

+ Manage quality assurance of clinical data

+ Lead development, review, and revision of study documentations, including but not limited to: Clinical Study Reports, Protocols, Operational Study Plans

+ Collaborate with functional leaders to prioritize and drive portfolio excellence

+ Provide innovative and creative solutions, proactively, to move business forward

+ Identify strengths and weaknesses of contributors and strategically present resources to develop the team


You would be an excellent fit if you meet the following qualifications:


+ BS/MS/PhD in Life or Health Sciences discipline

+ ~4-6+ years of upper-level Clinical Management experience

+ Demonstrated ability managing CROs, vendors, investigational sites, quality compliance, and clinical trial budgets within established deadlines/budget/resources

+ Clinical Research experience within Biotech/Pharmaceutical Industry

+ Well-versed in GCP and ICH guidelines with active certification highly desired

+ Expert knowledge of drug development process with FDA feedback/negotiation experience

+ Experience with oversight or active participation involved with pre-clinical strategic planning to early/late-stage clinical trials

+ Demonstrated leadership with focus on team development, team building, and/or mentorship


Salary will commensurate with educational background and experience level. There is the ability to work 100% remotely, with demonstrated ability of team leadership in a remote setting.


**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: 2021-03-29 Expires: 2021-04-29

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Director of Clinical Operations

Kelly Services
Charleston, SC 29409

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