Clinical Trials Manager

Weill Cornell Medical College•New York, NY

About The Position

Oversees the department’s Clinical Trials team, including general day-to-day administrative management and project oversight; spearheads team development and cohesion, and implements plans for strategic advancement. This role oversees all aspects of clinical research projects by planning, implementing, and managing the process involved.

Requirements

Bachelor's Degree
Approximately 2 years experience in clinical research field
Experience with regulatory, data management, budgeting and billing compliance aspects of clinical research.
Knowledge of FDA regulations governing clinical research.

Nice To Haves

Prior supervisory experience preferred.
Experience in developing business and strategic plans for new programs and program growth highly desired.

Responsibilities

Provides day-to-day supervision to the clinical trials team.
Facilitates communication between leadership, principal investigators, administration and team members to ensure departmental cohesion.
Assists with development and implementation of clinical research SOPs.
Develops quality maintenance plans to routinely analyze/evaluate workflows and to initiate new policies/procedures for continued quality improvement and overall program growth.
Manages and trains all clinical trial coordinators/assistants.
Provides guidance on proper research conduct.
Ensures study goals are achieved.
Identifies areas of improvement and carries out action plans to improve performance in targeted areas.
Manages multiple, highly-complex, and stringently-regulated clinical research protocols.
Oversees patient consenting, data collection, record management and regulatory compliance.
Reports findings to leadership.
Spearheads subject recruitment and retention for enrolling studies.
Oversees the development, implementation and execution of recruiting and retention campaigns.
Consults with Principal Investigators on project development and execution, including IRB protocol startup and continued compliance.
Tracks approval process and ensures all deadlines are met.
Serves as a liaison to various WCM clinical trials departments/offices, to ensure team compliance to Good Clinical Practice as well as adherence to WCM policies and funding agency regulations.
Assists with draft preparation of study-related budgets for clinical trials funding agencies.
Develops and negotiates study-related budgets with clinical study sponsors.
Collaborates with grants administrator(s) to track finances and manage the financial activity of grant portfolios, including pre- and post-award grant management activities.
Regularly reports to leadership on these activities.
Collaborates with principal investigators and the clinical trials team to manage Study reporting to various agencies or companies, including study sponsors and funding agencies/organizations, as well as oversight organizations.
Oversees inter-departmental and inter-site clinical trials projects; manages communication and project development and execution.
Serves as liaison to study clinical trials sponsors and funding agencies/organizations.
Provides stakeholders with status updates, issues, key activities and changes to overall protocol.
Works closely with sponsor, site and study personnel on regulatory issues.
Develops policies and procedures pertaining to regulatory and monitoring processes for clinical trials.
Leads regulatory educational training events for personnel at various sites.
Develops regulatory reports and associated documentation in accordance with SOPs and study specific processes.