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 company’s 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 Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions 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 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.