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Site Lead
3 months ago
Title: Site Lead
Location: Blue Bell, PA (Must go onsite 4 days a week)
Type: Perm
Start Date: ASAP
Leading Biotech Company located in Blue Bell, PA is hiring a Site Lead with 5+ years industry experience. If you want to be a part of this groundbreaking work, please apply
The Site Lead will report directly to the Senior Director Clinical Operations. This position has the responsibility of supporting the companys clinical operations function in close collaboration with research, development, and other functions. This includes working directly with the study team, vendors, and clinical study sites to ensure that clinical trials are conducted in a manner compliant with SOPs, ICH/GCP/CFR regulatory guidelines, as well as in line with company goals, timelines, and budgets.
A BA/BS degree required; advanced degree with scientific or health-care training preferred
Minimum of at least 3-4 years of Onsite Clinical Monitoring experience. At least 1-year additional experience in related field
Advanced site monitoring; and study site management skills
Thorough knowledge of monitoring procedures and strong understanding of the drug accountability process
Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Strong knowledge of rare disease clinical research highly desired
Knowledge and experience in gene therapy and gene editing, preferred
Experience with pediatric, in-patient / hospital-based studies, highly desired
Experience monitoring global clinical trials for a product through all clinical phases of clinical development
Demonstrated career success as a seasoned CRA, effective organizational skills, excellent verbal and written communication skills and high attention to detail
Excellent working knowledge of FDA & ICH/GCP/CFR regulations and guidelines
Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals
A professional who inspires trust and confidence in others. A resourceful, energetic self-starter who can shift between collaboration and execution
Possess unquestionable integrity with the highest ethical standards
Willingness and ability to participate in domestic and international travel, as required, up to 20%. Valid driver's license and current passport
System One, and its subsidiaries including Joul, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.