SUMMARY DESCRIPTION The Clinical Trial Manager is responsible for the execution of clinical trials and plays a critical role in integrating staff activities towards the goal of efficiently completing clinical trials. Manages the daily activities of designated clinical functions. Responsible to successfully move programs through the clinical research process in a timely manner, in adherence with Good Clinical Practice (GCP), appropriate Standard Operating Procedures (SOPs), and government regulations.
*Seeking someone who can travel to NYC periodically but will work remote most of the time.
Oversee and manage all or some aspects of a clinical trial in accordance with company SOPs, ICH/GCP regulations and study-specific manuals and procedures.
Identify and ensure compliance with key study quality metrics and determine appropriate action in conjunction with Study Team.
Align study start-up, enrollment, study conduct and close-out activities with project goals.
In collaboration with the study team, identify risks to study and develop risk mitigation plans, including communication with management when necessary.
Review monitoring reports and monitoring visit letters to assess trends and site performance.
Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study manuals, and study plans, electronic case report forms, and any other clinical research related documents in collaboration with the study team.
Create and implement study-specific tools to ensure clean data and timely data entry working with biometrics group, and perform clinical data review of data listings and summary tables, including query generation
Organize and manage internal team meetings, investigator meetings and other trial-specific meetings.
Identify, select, and monitor performance of investigational sites for clinical studies.
Manage Clinical Trial Associates and Clinical Data Coordinators who assist in carrying out Clinical Operations activities.
Bachelor’s or Master’s degree in a life-science discipline.
At least 6 years biotech or pharmaceutical development experience with at least 2 years trial management experience is required.
Knowledge of ICH GCP and FDA regulatory requirements is required.
Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.
Good written and verbal communication skills.
This position is expected to compensate $80,000-$90,000 salary depending on experience.
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 interests-it's 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.
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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.