Clinical Trials Project Manager

Site: The Brigham and Womens Hospital Inc.

Mass General Brigham relies on a wide range of professionals including doctors nurses business people tech experts researchers and systems analysts to advance our mission. As a not-for-profit we support patient care research teaching and community service striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

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.

Job Summary

The Department of Psychiatry at Brigham and Womens 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 Womens 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 Womens 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:

Indicate key areas of responsibility major job duties special projects and key objectives for this position. These items should be evaluated throughout the year and included in the written annual evaluation.


1. The PM will be the main point of contact for all research activities and be the liaison with the study PI sites and stakeholders

2. Develop and maintain draft and final study protocol consolidating and incorporating comments and changes from the Investigators

3. 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

4. Prepare collect and review regulatory documents necessary for IRB approval and site activation

5. Responsible for determining site feasibility and selection

6. Develop informed consent form (ICF) for clinical trial

7. Contact sites to review study issues and data review

8. Schedule coordinate and develop agenda and minutes for Coordinator Conference calls to be held quarterly during the course of the study

9. Responsible for Remote/In-house monitoring of the trial

10. Coordination of the annual Stakeholders meetings

11. Liaison with grants offices at both the primary institution as well as those of the subcontract organizations to ensure subcontracts are executed

12. Work with the finance team to ensure proper payments and invoicing

13. On a daily basis executes the procedural managerial and policy decisions made for the study.

14. Participates in all decisions made for the studies identify problems and make modifications needed and works to implement solutions.

15. Responsible for the development and oversight of project budget and timelines.

16. Responsible for ensuring on-going IRB approval for the studies.

17. Responsible for the oversight of all supplies equipment and files.

18. Has direct management responsibility for all study personnel including hiring firing discipline evaluation orientation and training.

19. Directly responds to inquiries regarding study protocol and policy.

20. All other duties as assigned.

Education
Bachelors Degree Related Field of Study required

At least 1 year of full-time research experience post bachelors degree or equivalent significant research experience.
Masters 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.

Physical Requirements

• Standing Frequently (34-66%)
• Walking Frequently (34-66%)
• Sitting Occasionally (3-33%)
• Lifting Frequently (34-66%) 35lbs (w/assisted device)
• Carrying Frequently (34-66%) 20lbs - 35lbs
• Pushing Occasionally (3-33%)
• Pulling Occasionally (3-33%)
• Climbing Rarely (Less than 2%)
• Balancing Frequently (34-66%)
• Stooping Occasionally (3-33%)
• Kneeling Occasionally (3-33%)
• Crouching Occasionally (3-33%)
• Crawling Rarely (Less than 2%)
• Reaching Frequently (34-66%)
• Gross Manipulation (Handling) Frequently (34-66%)
• Fine Manipulation (Fingering) Frequently (34-66%)
• Feeling Constantly (67-100%)
• Foot Use Rarely (Less than 2%)
• Vision - Far Constantly (67-100%)
• Vision - Near Constantly (67-100%)
• Talking Constantly (67-100%)
• Hearing Constantly (67-100%)

Hybrid

221 Longwood Avenue

40

Regular

Day (United States of America)

Pay Range

$63252.80 - $102596.00/Annual

Grade

7

At 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 addition to competitive base pay we offer comprehensive benefits career advancement opportunities differentials premiums 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.

2200 The Brigham and Womens 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 Veterans 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 .

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