Clinical Trials Project Manager

Mass General Brigham•Boston, MA

2d•$63,253 - $102,596•Hybrid

About The Position

The Department of Psychiatry at Brigham and Women’s Hospital is seeking a Clinical Trials Project Manager for a Patient Centered Outcomes Research Institute (PCORI) study. This study will conduct a comparative effectiveness study between Electroconvulsive therapy (ECT) and Subanesthetic Intravenous Ketamine for Acute Suicidal Depression (ASD). The Project Manager will work under the direction of the Principal Investigator, Dr. Amit Anand, and will be responsible for all activities of the clinical trial. This includes executing daily procedural, managerial, and policy decisions, participating in study decisions, identifying modifications to policies and procedures, budget oversight, grant writing and proposals, and direct management of study personnel.

Requirements

Bachelor's Degree in a related field required.
At least 1 year of full-time research experience post bachelor’s degree or equivalent significant research experience.
Directly related experience in clinical research: 3-5 years required.
Strong organizational and communication skills.
Demonstrated analytical skills.
Effective problem-solving skills.
Ability to supervise and train staff effectively.
Strong database management and computer skills.
Aptitude for budget management.

Nice To Haves

Master's Degree in a related field preferred.
Prior Supervisory Experience: 2-3 years preferred.

Responsibilities

Serve as the main point of contact for all research activities and act as the liaison with the study PI, sites, and stakeholders.
Develop and maintain draft and final study protocols, incorporating comments and changes from investigators.
Assist in the planning and conduct of PI/Coordinator meetings, including presenting scientific and operational topics, and preparing agendas and slides.
Prepare, collect, and review regulatory documents for IRB approval and site activation.
Determine site feasibility and selection.
Develop informed consent forms (ICF) for the clinical trial.
Contact sites to discuss study issues and data review.
Schedule, coordinate, and develop agendas and minutes for quarterly Coordinator Conference calls.
Responsible for remote/in-house monitoring of the trial.
Coordinate annual Stakeholders meetings.
Liaise with grants offices at the primary institution and subcontract organizations to ensure subcontracts are executed.
Work with the finance team to ensure proper payments and invoicing.
Execute procedural, managerial, and policy decisions for the study on a daily basis.
Participate in all study decisions, identify problems, make necessary modifications, and implement solutions.
Develop and oversee project budget and timelines.
Ensure ongoing IRB approval for the studies.
Oversee all supplies, equipment, and files.
Directly manage all study personnel, including hiring, firing, discipline, evaluation, orientation, and training.
Respond to inquiries regarding study protocol and policy.
Perform all other duties as assigned.