Dana-Farber Cancer Institute · 20 hours ago
Clinical Research Project Manager - Breast Oncology
Dana-Farber Cancer Institute is a leader in life-changing breakthroughs in cancer research and patient care. They are seeking a Clinical Research Project Manager I to coordinate and manage Breast Oncology clinical trial activities, ensuring compliance and efficient trial execution.
CommunitiesHealth CareHealth DiagnosticsHospitalNon ProfitOncology
Responsibilities
Manage the daily operations of assigned clinical trials, ensuring efficient execution and adherence to timelines while maintaining compliance with clinical trial regulations. This involves monitoring budgets, resources, and coordinating with cross-functional teams to meet project milestones
Develop and maintain the TMF, ensuring all essential documents are organized, accessible, and compliant with Good Clinical Practice (GCP) standards. Regular updates are conducted to ensure compliance with regulatory standards and institutional policies
Assist the Principal Investigator (PI) in developing protocols and consent forms for initial applications and amendments, ensuring they meet regulatory requirements and are easily understood by participants. This requires translating complex scientific concepts into clear, concise documents
Initiate, plan, and oversee the start-up, active, and close-out phases of clinical trials, particularly for PI-initiated and multi-center studies. Coordination with stakeholders, including site staff and external partners, ensures smooth transitions between phases and adherence to timelines
Design case report forms based on PI directives and maintains study-related databases, ensuring data integrity and compliance with clinical trial standards. Prepare protocol-related reports and data summaries to support ongoing research activities and decision-making
Schedule research team meetings and conference calls, facilitate mailings, and perform other project-related administrative tasks to ensure effective communication and coordination among team members and external collaborators
Qualification
Required
Bachelor's degree required. Field relevant to clinical research
Three (3) years of experience in clinical research or project management, ideally within multi-center oncology trials, with specific experience in managing clinical trial operations
Basic understanding of clinical trial processes and regulatory requirements, including Good Clinical Practice (GCP) guidelines
Familiarity with trial management software and tools, such as EPIC and OnCore, for efficient trial coordination
Awareness of data management practices and documentation standards, with an emphasis on compliance and accuracy
Strong organizational and time management skills to handle multiple tasks efficiently, ensuring adherence to clinical trial timelines
Effective communication skills for interacting with research staff, stakeholders, and regulatory authorities
Basic problem-solving skills to address project-related issues, with the ability to anticipate and mitigate potential challenges
Ability to work independently under general supervision, while maintaining compliance with clinical trial protocols
Capability to learn and adapt to new procedures and technologies, including updates in clinical trial regulations
Competence in maintaining accurate records and documentation, ensuring compliance with regulatory standards
Understanding of ethical considerations and patient confidentiality in clinical trials
Ability to collaborate effectively with cross-functional teams and external partners to support trial objectives
Preferred
Experience in an academic institution with a proven track record of success in the clinical research field is preferred, particularly in roles involving clinical trial coordination and management
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.
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 (191)
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
Recent News
2026-01-13
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