Dana-Farber Cancer Institute · 2 hours ago
Senior Clinical Research Manager
Brookline, MA
Full-time
Hybrid
Mid, Senior Level
$105K/yr - $130K/yr
5+ years expDana-Farber Cancer Institute is a leader in life-changing breakthroughs in cancer research and patient care. They are seeking a Senior Clinical Research Manager to provide strategic and operational oversight of the adult medical oncology clinical trial portfolio across multiple regional locations, ensuring compliance and performance benchmarks are met while supervising research staff.
CommunitiesHealth CareHealth DiagnosticsHospitalNon ProfitOncology
Responsibilities
Clinical Trials Operations Clinical Research Managers (CRM) are responsible for the oversight of their disease group’s clinical trial portfolio and all related regulatory, compliance and performance metrics requirements
The CRM will oversee the processing of protocols through DFCI Institutional Review Board (and other institutions’ IRBs) when appropriate
The CRM will collaborate with the DFCI Clinical Trials Office (CTO), the Office for Human Research Studies (OHRS), and the Office of Data Quality (ODQ) to fulfill local and federal requirements governing human clinical trials
The CRM will Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution
The CRM will assist the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and Contracts offices
Work with grant managers and other financial managers in the reporting and accounting of these funds
Oversees and coordinates the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials
In collaboration with clinical research administration and grant managers, may maintain, monitor and reconcile all study and related grant finances
These may include budget development, expenditure tracking, procurement, salary offset worksheets and staffing
Assists the principal investigator in preparing manuscripts for publication
The CRM will collaborate with the DFCI CTO, and DF/HCC ODQ to develop study forms, database information, and to establish guidelines for monitoring data quality control for PI Initiated studies / Multi-Center Trials
The CRM will oversee the subject enrollment, protocol treatment and follow-up care processes for protocol patients
Oversees registration of protocol patients with ODQ or OnCore policies and pharmaceutical company as outlined in protocol
If applicable for coverage or trial assignments, responsible for data entry of study-specific activity, including but not limited to subject visit tracking, monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc. into Clinical Trial Management System contemporaneously with activity completed
Responsible for reviewing, approving, and reporting on data entry completed by supervised research staff in Clinical Trial Management System
The data entry oversight may include, but is not limited to, Subject Visit Tracking for subject-specific visits, time and effort spent on study-specific activities and other administrative tasks, etc
Regulatory & Compliance Assumes responsibility for essential document compliance for entire portfolio
Implements systems to monitor and ensure regulatory document collection and maintenance compliance
Assumes responsibilities for all clinical trial reporting requirements, safety event, annual approval, deviations etc
Implements systems to monitor portfolio compliance
Responsible for the disease group’s transition from paper to electronic regulatory binders
Will maintain per DFCI CTO standards
Data Management & Clinical Trial Monitoring Assumes responsibilities for data management and compliance for entire portfolio
Maintains schedules and procedures necessary for timely and complete data collection
Regularly reports data compliance status to key stakeholders, i.e. DFCI PI, study Sponsor, DFCI CTO
Implements corrective action to maintain data compliance when necessary
Submits required “progress / tracking” reports to key stakeholders, when applicable
Staff Hiring, Supervision, Training & Development Responsible for the recruitment and oversight of all of the research staff
Ensure that all staff complete required mandatory and ongoing training in a timely manner
Develops and oversees a program specific on-boarding and orientation process and conducts annual performance evaluations and competency assessments of research staff
Develops a standard supervision schedule with research staff including periodic individual and group supervision meeting
Will develop and agenda, take attendance and document all applicable meetings
Will communicate all personnel concerns to their immediate supervisor and to DFCI HR partner for the appropriate response and follow up
Qualification
Required
Bachelor's Degree required, with a minimum of 7 years of related experience or Master Degree with 5 years experience
Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process
Experience in protocol development, data compilation and analysis
Skilled at developing tracking systems to ensure timely data management by the clinical research staff
Expert knowledge of Federal and State regulations as they relate to research
Strong interpersonal, organizational and communication skills
Computer skills including the use of Microsoft Office and working knowledge of Livelink; EPIC and OnCore applications
Supervises study management staff, including clinical research coordinators, students, volunteers, and other research assistants
Company
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute is a center dedicated to carrying out adult and pediatric cancer treatment activities and advanced research.
1001-5000 employees
H1B Sponsorship
Dana-Farber Cancer Institute 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 (148)
2024 (145)
2023 (155)
2022 (139)
2021 (105)
2020 (113)
Funding
Current Stage
Late StageTotal Funding
$88.08MKey Investors
Elaine and Eduardo Saverin FoundationThe DeGregorio Family FoundationLlama
2025-11-24Grant· $20M
2025-05-06Grant· $1M
2024-09-24Grant· $0.5M
Leadership Team
Edward Benz
CEO
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