Bachelor's degree in nursing, Biology, Public Health, or related field; Master's preferred.
6+ years managing clinical trials, with at least 2 years in a leadership role; 9 years preferred.
Excellent communication skills for effective interaction with team members and external stakeholders.
Strong problem-solving, organizational, and leadership abilities required.
Detail-oriented with the ability to meet deadlines under pressure.
Proficient in basic computer applications for project operations.
Experience in writing clinical study procedures is a plus.
Responsibilities
Monitor and report on clinical trial progress, including budgets and timelines.
Prepare and review documents related to the clinical study.
Organize clinical study meetings and ensure resource availability.
Develop training materials and train clinical staff at sites.
Communicate key study updates to sites through webinars and other methods.
Lead the clinical project team and facilitate study team meetings.
Resolve issues and participate in process improvement initiatives.
Benefits
Opportunity to work on a pioneering clinical trial for acute stroke treatments.
Collaborative work environment with a focus on team leadership.
Professional development through training and project management experience.
Engagement with a network of clinical research professionals and external consultants.
Full Job Description
Job Description
StrokeNet Thrombectomy Endovascular Platform (STEP) is a unique, first-of-its-kind platform trial that is looking at various treatments for patients with an Acute Stroke. The Clinical Trials Manager will oversee several aspects of national project management for this unique clinical trial. The Clinical Trials Manager will work directly with performance sites in the clinical trial. The appropriate candidate should have a clinical background and extensive clinical research experience.
Responsibilities
Monitor and report on the progress of delegated clinical trials, which includes budgets and timelines
Prepare, oversee, and review documents that are related to the assigned clinical study
Arrange or help in organizing clinical study meetings
Ensure the availability of necessary resources for the execution of clinical projects
Help develop training materials and train clinical staff at sites
Communicate with sites regarding key study updates during study webinars and other avenues
Lead the clinical project team and various study team meetings
Fully involved in resolving issues; take part in procedure improvement initiatives
Attain clinical study goals by working with other members of the study team to outline their priorities, and to also resolve conflicts that may come up in the project process
Work hand-in-hand with the study team to manage documents that are related to the clinical study
Responsible for maintaining the protocol versions and manual of procedures for the trial
Help prepare safety reports in collaboration with clinical leaders of the project and sites
Work collaboratively with team members to ensure regulatory compliance
Perform related duties based on departmental need.
Qualifications
Bachelor's degree in nursing, Biology, and Public Health or related scientific/health field, Masters preferred.
6+ years of experience managing clinical trials, including 2 years in a management/leadership role; 9 years of experience highly preferred
Additional Preferred Qualifications:
Possess excellent communication skills so as to be able to effectively convey messages across to both study team members and other external people like vendors and external consultants
Good problem-solving, organizational, and leadership skills are highly required
Ability to work with little or no supervision
Ability to pay keen attention to detail at all times
Must be able to work within stipulated timeframes or deadlines even in the face of multiple responsibilities or projects
Must be able to work as part of a team or in most cases lead a team
Must have a 'one of a kind' work ethic, and must exhibit a great level of self-discipline
Ability to organize and motivate other members of the study team
Proficient user of basic computer applications for the execution of daily project operations
Experience in writing clinical study procedures and other clinical documents is a plus
Experience in an academic or clinical setting in the area of clinical specialization
SoCRA and/or ACRP certification
About Mount Sinai Hospital
Mount Sinai Hospital is a hospital network based in New York City. It was founded in 1852 and is one of the oldest and largest teaching hospitals in the United States. The hospital has been ranked among the top hospitals in the country by U.S. News & World Report and is known for its excellence in patient care, research, and education. Mount Sinai Hospital is affiliated with the Icahn School of Medicine at Mount Sinai and has a staff of over 7,000 physicians, nurses, and other healthcare professionals.
