Clinical Research Project Manager

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

We are seeking an intellectually curious and highly organized individual with clinical trial interest/experience to serve as a Project Manager in the Office of Clinical Research (OCR) Center for Clinical Investigation (CCI). The candidate will work with the Research Operations Director, Department Managers, and Principal Investigators. The Project Manager will supervise the Research Coordinator Network (RCNet) team.

The mission of the OCR/CCI is to strengthen the culture for clinical research at the Brigham and Women’s Hospital by building services helpful to clinical investigators and facilitating the success of individual investigators.

The Project Manager will be responsible for developing and maintaining the infrastructure of research studies and clinical trials by supporting the design, planning, and management of the projects.

Principal Duties and Responsibilities:

Provides strong leadership as a liaison between the investigators, sites, and sponsors. This includes:

· Developing a plan for all projects and ensuring follow-up on all discussions, and requesting an update on projects.

· Meeting with the research teams regularly to review trial projects, timelines and action items

· Manage, assign and regulatory, compliance and sponsor study start-up activities along with the project management team

· Foster a team environment

· Lead additional special project oversight as requested

Operational Management

Develop and maintain the infrastructure of studies and clinical trials by supporting the design, planning, and management activities, including the following:

Regulatory

· Submit IRB Applications and required reporting, including commercial IRB submissions and cede review applications

· Manage site regulatory documents and binders

· Manage ClinicalTrials.gov postings

Study documents

· Assist in preparation of protocol and informed consent forms

· Assist with recruitment materials

· Oversee preparation and maintenance of Manuals of Procedures

· Oversee site and staff training materials

· Manage study portal and access to study documents and trial materials

Leadership

· Lead departmental therapeutic program management pipeline from an administrative and regulatory perspective

· Maintain tracking, utilization and operational documentation and procedures for the program

· Oversee the clinical research coordinator assigned to these studies

· Oversee cross functional teams that implement this program area

· Manage study portal and access to study documents and trial materials

• Extensive knowledge of federal and state regulations governing clinical research, and good clinical practice guidelines, regulatory guidance and local policies

• Lead and collaborate with CCI staff to implement regulatory and study based training and implementation of new or revised regulation, guidance and or local policy

• Present regulatory status for disease group portfolio at applicable research meetingTs

Education Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Research Related Experience 5-7 years required and Supervisory Experience 1-2 years preferred Knowledge, Skills and Abilities - Ability to make independent effective decisions. - Strong organizational and communication Skills. - Ability to effectively supervise and train Staff. - Strong database management and computer skills. - Demonstrated analytical skills to problem solve effectively. - Must possess strong budget management skills.

Hybrid221 Longwood Avenue40RegularDay (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, 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 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