Site: The Brigham and Women's 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.

Job Summary

This position reports directly to the Clinical Events Committee (CEC) Assistant Project Manager/ Sr. Project Manager for assigned clinical trial(s). This position is responsible to process potential endpoint events reported by the investigative sites for event adjudication by the TIMI CEC.
This position assists with the day-to-day operational tasks of assigned CEC department trial.

This position reports directly to the Clinical Events Committee (CEC) Assistant Project Manager/ Sr. Project Manager for assigned clinical trial(s). This position is responsible to process potential endpoint events reported by the investigative sites for event adjudication by the TIMI CEC.
This position assists with the day-to-day operational tasks of assigned CEC department trial.
This position reports directly to the Clinical Events Committee (CEC) Assistant Project Manager/ Sr. Project Manager for assigned clinical trial(s). This position is responsible to process potential endpoint events reported by the investigative sites for event adjudication by the TIMI CEC.
This position assists with the day-to-day operational tasks of assigned CEC department trial.

1. Review source documents submitted by investigative sites for potential endpoint events to ensure documents were uploaded to the correct event in the electronic adjudication system (EAS).
2. Provide a hyperlink to MGB’s secure file transfer protocol (sFTP) to investigative site personnel for source document transfer if the EAS is unavailable, not being used for the trial, or site personnel do not have access.
3. Enter and track events and event statuses for trials not utilizing electronic adjudication into an Excel database.
4. Submit documents to the designated translation vendor for translation into English and enter the submission into the translation tracker as directed.
5. Perform a quality review of translated documents to ensure PII has been completely redacted by the vendor. Notify the CEC Lead Coordinator or Sr. Project Manager of redaction oversights. Track, and redact the information following trial-specific conventions.
6. Review translated source documents for potential treatment unblinding information and redact information if identified. Track any findings following trial-specific conventions.
7. Compile the event dossier consisting of submitted source documents and the patient profile report downloaded from the designated location provided by the pharmaceutical sponsor/sponsor vendor.
8. Advance events through the adjudication workflow following trial-specific procedures.
9. Submit events to the assigned Medical Reviewer (MR) and process any queries to the investigative sites following trial-specific procedures.
10. Submit MR-approved events for adjudication at the scheduled CEC meeting. Process adjudicator queries for additional information following trial-specific conventions.
11. Utilize the adjudication system’s audit trails to identify changes made to events before and after adjudication.
12. Participate in system validation by performing user acceptance testing (UAT) pre-system go-live and for system changes for the trial’s duration.
13. May assist in the training and orientation of new staff/trial-team members.
14. Assist in the scheduling of CEC meetings using MS Teams.
15. Use/s the Mass General Brigham values to govern decisions, actions and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration
16. Other duties as assigned

Education
Bachelor's Degree Related Field of Study

A combination or education and experience may be substituted for requirements

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

No fiscal responsibility

No direct reports


Proficiency in MS Office products (Outlook, Word, Excel, and PowerPoint) and familiarity with databases

Possess strong interpersonal skills to effectively communicate with cross functional teams including staff at all levels of the organization

Ability to successfully negotiate and collaborate with others of different skill sets, backgrounds and levels within and external to the organization

Strong problem solving and negotiation skills

Requires minimal direction from leadership and possesses the ability to learn quickly

Hybrid

350 Longwood Avenue

40

Regular

Day (United States of America)

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 (857)-282-7642.

Mass General Brigham Competency Framework