Clinical Research Manager jobs in United States
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Mass General Brigham · 3 days ago

Clinical Research Manager

Mass General Brigham is a not-for-profit organization committed to patient care, research, teaching, and community service. They are seeking a Clinical Research Manager to provide operational and supervisory oversight for clinical trials, ensuring compliance and managing a team of research coordinators. The role includes coordinating multi-center trials, maintaining regulatory compliance, and collaborating with various stakeholders.

Health CareHome Health CareMedical
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H1B Sponsor Likelynote

Responsibilities

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)
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
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
Collaborating with project investigators and research sites to ensure targets are met for study start up, site activation, patient recruitment and enrollment
Safety management and reporting to FDA, Data and Safety Monitoring Boards, Medical Monitors, funding agencies and other regulatory bodies
Collecting, reviewing and approving of all required regulatory documents; and working to ensure the study Trial
Managing multi-center trials funded by NIH, Industry standards
Collaborate with grants management team to prepare progress reports
Provide safety management oversight for studies, in collaboration with study PI and safety boards

Qualification

Clinical trial coordinationRegulatory complianceTeam managementBudget managementDatabase managementAnalytical skillsTime managementCommunication skillsProblem-solving skillsInterpersonal skills

Required

Bachelor's Degree Related Field of Study required
Progressively more responsible experience in a research related field 3-5 years 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
Sound interpersonal skills
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

Preferred

Master's Degree Related Field of Study preferred
Prior Supervisory Experience 1-2 years preferred

Benefits

Comprehensive benefits
Career advancement opportunities
Differentials
Premiums
Bonuses
Recognition programs

Company

Mass General Brigham

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Mass General Brigham specializes in providing medical treatments and health diagnostics services.

H1B Sponsorship

Mass General Brigham has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (77)
2024 (61)
2023 (93)
2022 (70)
2021 (80)
2020 (29)

Funding

Current Stage
Late Stage

Leadership Team

E
Erin Flanigan
SVP, Human Resources, Community, Specialty Hospital Division
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O’Neil A. Britton
Chief Integration Officer, Executive Vice President
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Company data provided by crunchbase