Senior Clinical Research Program Manager

Jobtailor; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Jobtailor in Boston seeks an experienced clinical research program administrator to coordinate administration of the program, oversee protocol management, supervise staff, and support PIs with planning and grant preparation. You will coordinate data management, transfers, and data sharing, while managing budgets and financial planning across multiple studies.

The role requires 5–7 years of research experience, strong knowledge of FDA/NIH guidelines, and proficiency with OnCore and

Qualifications

• 5-7 years of research-related experience required.
• Supervisory experience preferred: 3-5 years.
• Thorough knowledge of federal and institutional policies governing clinical research.
• Broad understanding of hospital practices and policies.
• Knowledge of clinical research protocols.
• Strong interpersonal, communication, and organizational skills.
• Proficiency in Microsoft Office and related software.
• Ability to learn new systems quickly.
• Knowledge of OnCore and ClinicalTrials.gov.
• No experience in lieu of a degree accepted.

Responsibilities

• Coordinate administration of the clinical research program
• Oversee research protocol management
• Supervise and train clinical research staff
• Support principal investigators with strategic planning, team organization, and grant preparation
• Coordinate materials transfers and data management/sharing
• Manage budgets and financial planning
• Support conference and travel planning
• Manage hiring, onboarding, education, and training programs for clinical research coordinators
• Oversee time tracking and project communication
• Manage IRB submissions, continuing reviews, protocol expirations, and reporting
• Develop recruitment strategies and screen participants
• Serve as liaison between patients, families, and principal investigators
• Manage data/materials transfer agreements and develop data collection systems
• Perform data validation and quality control
• Facilitate monitoring and auditing visits
• Provide compliance and Good Clinical Practice guidance
• Complete study close-outs and fund inactivation

Skills

Protocol Management

Staff Supervision

Budget Oversight

Data Management

Grant Preparation

Communication Skills

Project Coordination

Interpersonal Skills

Adaptability

Education

Bachelor's degree required

Tools

OnCore

ClinicalTrials.gov

Web-Based Data Collection Systems

Microsoft Office

Job description

• Coordinate administration of the clinical research program
• Oversee research protocol management
• Supervise and train clinical research staff
• Support principal investigators with strategic planning, team organization, and grant preparation
• Coordinate materials transfers and data management/sharing
• Manage budgets and financial planning
• Support conference and travel planning
• Manage hiring, onboarding, education, and training programs for clinical research coordinators
• Supervise clinical research coordinators, including performance support and annual evaluations
• Define study responsibilities and level of effort
• Oversee time tracking and project communication
• Support clinical trial billing activities
• Oversee multiple clinical research projects from inception to completion
• Define project scope, goals, deliverables, and timelines
• Develop protocols, organize meetings, and ensure adherence to protocols, data agreements, and quality standards
• Execute and reconcile financial transactions and industry-sponsored payments using MGB OnCore and Insight
• Oversee procurement and maintenance of study equipment
• Manage IRB submissions, continuing reviews, protocol expirations, and reporting
• Maintain knowledge of FDA/NIH guidelines, IND/IDE applications, and ClinicalTrials.gov requirements
• Develop recruitment strategies and screen participants
• Serve as liaison between patients, families, and principal investigators
• Manage data/materials transfer agreements and develop data collection systems
• Perform data validation and quality control
• Facilitate monitoring and auditing visits
• Provide compliance and Good Clinical Practice guidance
• Complete study close-outs and fund inactivation
• Manage protocol inquiries, participant correspondence, and trial progress reporting
• Manage multi-site studies, site feasibility, compliance assessment, contracting support, and agreement execution
• Train site staff on protocols and web-based data collection systems
• Develop standard operating procedures
• Collaborate with investigators, clinicians, software developers, and laboratory personnel
• Provide human research education at MGB institutions

Requirements

• 5-7 years of research-related experience required
• Supervisory experience preferred: 3-5 years
• Thorough knowledge of federal and institutional policies governing clinical research
• Broad understanding of hospital practices and policies
• Knowledge of clinical research protocols
• Strong interpersonal, communication, and organizational skills
• Proficiency in Microsoft Office and related software
• Ability to learn new systems quickly
• Knowledge of OnCore and ClinicalTrials.gov
• Ability to handle confidential information and maintain professionalism
• Detail-oriented, proactive, and adaptable to changing priorities
• Ability to work independently and as part of a team
• Phlebotomy and ECG performance as required
• No experience in lieu of a degree accepted

Core Competencies

Demonstrates expertise in clinical research program administration, including protocol management, budget oversight, and compliance with FDA/NIH guidelines. Proficient in managing clinical research staff, developing recruitment strategies, and ensuring adherence to quality standards throughout multiple projects.

Highest-signal resume keywords

• Clinical Research Program Administration
• Protocol Management
• Budget Oversight
• OnCore Proficiency
• Good Clinical Practice Compliance

Hard Skills

• Clinical Research Protocols
• Data Management
• Financial Planning
• Phlebotomy
• ECG Performance
• Data Validation
• Quality Control
• Recruitment Strategies
• Study Close-Outs
• IRB Submissions

Soft Skills

• Interpersonal Skills
• Communication Skills
• Organizational Skills
• Detail-Oriented
• Adaptability

Industry Keywords

• Clinical Research
• FDA Guidelines
• NIH Guidelines
• Good Clinical Practice
• Multi-Site Studies

Tools & Technologies

• Microsoft Office
• MGB OnCore
• ClinicalTrials.gov
• Web-Based Data Collection Systems