Clinical Trials Project Manager

Project Manager For Pcori Study

The Department of Psychiatry at Brigham and Women's Hospital is at the forefront of advancing the care of patients with mind-brain disorders through clinical, research, and educational innovation and excellence. The Department of Psychiatry at the Brigham and Women's Hospital is a major teaching hospital of Harvard Medical School and is dedicated to providing the highest level of care for patients and their families, informed by the innovative research being conducted by our renowned faculty.

This Project Manager position is for a Patient Centered Outcomes Research Institute (PCORI) study that will conduct a comparative effectiveness study between Electroconvulsive therapy (ECT) and Subanesthetic Intravenous Ketamine for Acute Suicidal Depression (ASD) lead by Principal Investigator, Dr Amit Anand. Dr. Anand is the Director of Translational Clinical Trials Program at Brigham and Women's Hospital, Harvard Medical School. He also runs the Mood and Emotional Disorders specialty clinic. Dr. Anand has more than 25 years of clinical research experience in the area of mood disorders and has conducted and been a part of a number of mood disorders clinical trials as well as neuroimaging studies. He was part of the original team at Yale which discovered the antidepressant effects of ketamine in late 1990s.

Working under the direction of Principal Investigator, the Project Manager is responsible for all activities of clinical trial. Responsible for executing on a daily basis, the procedural, managerial and policy decisions made for the study. Participates in all decisions made for the study and identifies modifications of existing policies and procedures. Responsible for budget oversight and participates in grant writing and proposals. Has direct management responsibility of study personnel.

Principal Duties And Responsibilities

• The PM will be the main point of contact for all research activities and be the liaison with the study PI, sites, and stakeholders
• Develop and maintain draft and final study protocol, consolidating and incorporating comments and changes from the Investigators
• In collaboration with the PI, assist in the planning and conduct of the PI/Coordinator meeting by presenting appropriate scientific and operational topics, preparation of the meeting agenda and slides
• Prepare, collect and review regulatory documents necessary for IRB approval and site activation
• Responsible for determining site feasibility and selection
• Develop informed consent form (ICF) for clinical trial
• Contact sites to review study issues and data review
• Schedule, coordinate and develop agenda and minutes for Coordinator Conference calls to be held quarterly during the course of the study
• Responsible for Remote/In-house monitoring of the trial
• Coordination of the annual Stakeholders meetings
• Liaison with grants offices at both the primary institution as well as those of the subcontract organizations to ensure subcontracts are executed
• Work with the finance team to ensure proper payments and invoicing
• On a daily basis, executes the procedural, managerial, and policy decisions made for the study.
• Participates in all decisions made for the studies, identify problems and make modifications needed and works to implement solutions.
• Responsible for the development and oversight of project budget and timelines.
• Responsible for ensuring on-going IRB approval for the studies.
• Responsible for the oversight of all supplies, equipment, and files.
• Has direct management responsibility for all study personnel, including hiring, firing, discipline, evaluation, orientation and training.
• Directly responds to inquiries regarding study protocol and policy.
• All other duties as assigned.

Qualifications

Education
Bachelor's Degree Related Field Of Study Required

At least 1 year of full-time research experience post bachelor's degree or equivalent significant research experience. Master's Degree Related Field Of Study Preferred

Can this role accept experience in lieu of a degree? No

Licenses and Credentials

Experience
Directly related experience in clinical research 3-5 years required, and Prior Supervisory Experience 2-3 years preferred

Knowledge, Skills and Abilities

· 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.

· Must possess aptitude for budget management.

Additional Job Details (if applicable)

To apply, please send 1) your CV, 2) a 1-page statement of your scientific interests and career goals 3) letters or contact information for three references.

Remote Type

Hybrid

Work Location

221 Longwood Avenue

Scheduled Weekly Hours

40

Employee Type

Regular

Work Shift

Day (United States of America)

Pay Range

$63,252.80 - $102,596.00/Annual

Grade

7At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

EEO Statement:

2200 The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at View phone number on click.appcast.io.