Clinical Trial Project Manager

Mass General Brigham (Enterprise Services); Boston (MA); Remote; USD 70,000 - 90,000; Full time

Job summary

A prestigious healthcare institution seeks a Clinical Research Project Manager to coordinate multi-center clinical trials and manage a team of research staff remotely. Candidates should have a BA/BS degree and at least 3 years of research experience, including management. This role prioritizes compliance with federal regulations and requires excellent communication skills. Remote work is offered with some travel.

Qualifications

• Minimum of 3 years of research experience required, 4 years preferred.
• Minimum of 1 year of management experience required.
• Familiarity with the Code of Federal Regulation (CFR) and Good Clinical Practice (ICH GCP) is desirable.

Responsibilities

• Coordinate and manage several multi-center clinical trials.
• Supervise a team of research staff.
• Ensure compliance with regulatory standards.

Skills

Time management

Written communication

Verbal communication

Problem-solving

Leadership

Education

BA/BS degree

Master's degree

Job description

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 of their research portfolios.

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 (<25%)

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

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

Mass General Brigham Incorporated is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.