Senior Clinical Research Program Manager

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 #J-18808-Ljbffr