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Site Lead

2 months ago

Blue Bell, United States System One Full time

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

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