Clinical Trials Manager- Neurology

Mount Sinai Health System•New York, NY

About The Position

The Neurology department is seeking a Clinical Research Project Manager for the PCORI-funded Treatment with Endovascular Intervention for STroke Patients with Existing Disability (TESTED) clinical trial. TESTED is a comparative-effectiveness, observational, multicenter study evaluating endovascular acute stroke treatment for patients with pre-existing disabilities and addressing disparities in care for acute ischemic stroke. As the prime project manager, this role oversees national project management and works directly with clinical trial performance sites. The candidate should have a clinical background and extensive clinical research experience. The position leads the clinical project team, coordinates study activities and communications, supports grant and regulatory responsibilities, and works with study team members and sites to meet trial goals.

Requirements

Bachelor's degree in Nursing, Biology, Public Health, or a related scientific or health field.
At least 6 years of experience managing clinical trials, including 2 years in a management or leadership role.
Clinical background and extensive clinical research experience.

Nice To Haves

Master's degree preferred.
Excellent communication skills for conveying information to study-team members, vendors, external consultants, and other external contacts.
Problem-solving, organizational, and leadership skills.
Ability to work with little or no supervision.
Strong attention to detail.
Ability to meet deadlines while managing multiple responsibilities or projects.
Ability to work as part of a team and, when needed, lead a team.
Strong work ethic and self-discipline.
Ability to organize and motivate study-team members.
Proficiency with basic computer applications used in daily project operations.
Experience writing clinical-study procedures and other clinical documents.
Experience in an academic or clinical setting in the area of clinical specialization.
SoCRA and/or ACRP certification.

Responsibilities

Develop and manage changes to the protocol, ICD, MOP, CRFs, and study tools.
Plan investigator meetings.
Help lead monthly webinars and prepare slides.
Develop and circulate a monthly newsletter.
Develop and track training for sites.
Lead and maintain study-wide communications.
Analyze screen-failure data.
Develop recruitment materials, including brochures and videos.
Conduct and schedule site-readiness calls.
Manage grant activities, including involvement in overall grant finances.
Submit biannual reports to PCORI.
Answer clinical and protocol questions.
Ensure protocol compliance.
Maintain ClinicalTrials.gov information.
Develop strategies to build study enthusiasm and site engagement.
Communicate key study updates to sites through webinars and other channels.
Maintain communication with PCORI.
Lead the clinical project team and various study-team meetings.
Help resolve issues and participate in procedure-improvement initiatives.
Work with study-team members to outline priorities, achieve clinical-study goals, and resolve conflicts.
Manage clinical-study documents in collaboration with the study team.
Maintain protocol versions and the trial manual of procedures.
Help prepare safety reports in collaboration with project clinical leaders and sites.
Work collaboratively with team members to ensure regulatory compliance.
Perform related duties based on departmental need.