Clinical Research Manager jobs in United States
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Mass General Brigham · 5 hours ago

Clinical Research Manager

Mass General Brigham is a not-for-profit organization that supports patient care, research, teaching, and community service. They are seeking a Clinical Research Manager to oversee a team of research coordinators in managing multi-center clinical trials, ensuring compliance with federal regulations, and maintaining the quality and integrity of trial operations.

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

Qualification

Clinical trial coordinationRegulatory complianceTeam managementClinical PracticeTime managementProblem-solvingCommunicationInterpersonal skillsAdaptabilityInitiative

Required

Experience in clinical trial coordination and implementation
Ability to provide managerial, operational and supervisory oversight for a team of research coordinators/monitors
Direct management of individual trials
Hiring, training, and first-line supervision of research staff
Oversight responsibility of team's timeline management, clinical quality assessment and trial operations integrity
Ensuring compliance with Federal and local regulatory requirements
Coordination, regulatory maintenance, monitoring and timeline management of several multi-center clinical trials
Ongoing evaluation and verification of protocol procedures, regulatory and data compliance
Act as central communications liaison for all clinical trial collaborators
Work directly with entities within and outside the organization
Identify variance across participating sites' Standard Operating Procedures
Fulfill routine and expedited reporting requirements to all funding sponsors and regulatory boards
Provide first-line supervision to a minimum of 2-4 FTEs
Hiring and training of new staff
Executing performance evaluation, staff development and corrective action processes
Manage staff productivity and quality of work
Assist and consult with Senior PCORP Management on global program initiatives
Stay current with federal and local regulations, guidance and quality assurance trends
Exceptional time management skills
Excellent written and verbal communication skills
Ability to clarify and distill complex issues
Able to work successfully and independently in a remote environment
Able to manage diverse teams with different skillsets
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
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

Benefits

Comprehensive benefits
Career advancement opportunities
Differentials
Premiums
Bonuses
Recognition programs designed to celebrate your contributions and support your professional growth

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