Clinical Trial Project Manager

Site: Mass General Brigham Incorporated

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

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Program for the Coordination and Oversight of Research Protocols (PCORP) within the MGH Cancer Center Protocol Office specializes in the central coordination, monitoring and regulatory oversight of Investigator-initiated, multi-center clinical trials. PCORP is seeking candidates experienced in clinical trial coordination and implementation to provide managerial, operational and supervisory oversight for a team of research coordinators/monitors and their respective research trials.

The Clinical Research Project Manager will independently direct a team of research staff to coordinate, monitor and advance a portfolio of therapeutic oncology trials from concept through completion. Project Manager responsibilities include direct management of individual trials in addition to the hiring, training, and first-line supervision a team of research staff and the day-to-day operations other their research portfolios. The Project Manager has oversight responsibility of the team's timeline management, clinical quality assessment and trial operations integrity and for ensuring Sponsor-Investigator and Site Investigator compliance with Federal and local regulatory requirements. The Clinical Research Manager provides input into the assessment of program procedures and staff management, while maintaining a working knowledge of all aspects of clinical research management.

Qualifications

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Manager responsibilities include:

Trial and portfolio coordination

• Coordination, regulatory maintenance, monitoring and timeline management of several multi-center clinical trials within the Cancer Center
• Ongoing evaluation and verification of protocol procedures, regulatory and data compliance and alignment with federal and local regulations across all participating sites
• Act as central communications liaison for all clinical trial collaborators
• Work directly with entities within and outside the organization, including Investigators, funding sponsors, collaborators and vendors to establish workflow, monitor process and identify and resolve issues
• Identify variance across participating sites' Standard Operating Procedures and developing processes to ensure compliance
• Fulfill routine and expedited reporting requirements to all funding sponsors, monitoring boards, regulatory boards or other governing agencies (e.g. FDA, IRB, DSMB, etc)
• Occasional domestic travel required (

Supervisory:

• Provide first-line supervision to a minimum of 2-4 FTEs and/or assist with specialized management projects of equivalent responsibility.
• Hiring and training of new staff and assessment of ongoing continuing education and development needs of supervisees
• Executing performance evaluation, staff development and corrective action processes for direct report research staff, as needed
• Manage staff productivity and quality of work produced by assessing work effort on individual studies.

Management Team Responsibilities:

• Assist and consult with Senior PCORP Management on global program initiatives, including networking, program expansion and process improvement
• Stay current with federal and local regulations, guidance and quality assurance trends as they pertain to the conduct of clinical research. Assist in update and development of program operations to align with guidance.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

Skills Required:

• Exceptional time management skills with the capacity to prioritize among multiple tasks and change direction in response to fluctuating demands
• Excellent written and verbal communication skills
• Ability to clarify and distill complex issues to a variety of collaborators
• Able to work successfully and independently in a remote environment while demonstrating and fostering initiative and accountability
• Able to manage diverse teams with different skillsets, work styles, and professional roles
• Motivated to help team achieve results and meet deadlines
• Identifies key priorities and helps manage change and ambiguity
• Keen ability to anticipate and address potential issues proactively
• Problem-solving skills, including the ability to gather information, identify resources, and develop alternatives
• Familiarity with the Code of Federal Regulation (CFR) and Good Clinical Practice (ICH GCP)
• Knowledge of current and developing clinical research trends
• Sounds interpersonal skills

Additional Job Details (if applicable)

LICENSES, CERTIFICATIONS, and/or REGISTRATIONS:

• None

EDUCATION:

• BA/BS degree required, Master's preferred

EXPERIENCE:

• Minimum of 3 years research experience required, 4 years preferred.
• Minimum of 1 year of management experience required
• Prior supervisory experience within the Cancer Center Protocol Office preferred

SUPERVISORY RESPONSIBILITY:

• Orient and train new staff and may supervise a minimum of 2-4 FTEs

FISCAL RESPONSIBILITY:

• None

WORKING CONDITIONS:

• Duties will mainly be performed in a remote setting; limited in-office presence anticipated. Applicants may work in all states with the following exceptions: WY, ND, Puerto Rico, and the U.S. Virgin Islands.
• Less than 25% domestic travel required (1-2 field visits per month maximum)
• Position focuses on central trial coordination and does not include patient contact

Remote Type

Remote

Work Location

101 Merrimac Street

Scheduled Weekly Hours

40

Employee Type

Regular

Work Shift

Day (United States of America)

Pay Range

$62,004.80 - $90,750.40/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 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.

EEO Statement:

Mass General Brigham Incorporated 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

At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.