Dana-Farber Cancer Institute · 2 hours ago
Clinical Research Project Manager
Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. The Clinical Research Project Manager II manages day-to-day coordination and overall clinical trial activities for the Psychedelic-Assisted Therapy Research Program, ensuring compliance with clinical trial regulations and overseeing the full lifecycle of complex clinical trials.
CommunitiesHealth CareHealth DiagnosticsHospitalNon ProfitOncology
Responsibilities
Oversee the coordination, execution, and management of several Phase I, II, III PI-Initiated/Multi-Center oncology trials within the Clinical Trials Office, ensuring compliance with clinical trial regulations
Collaborate with senior managers to develop comprehensive project plans that provide direction, expectations, and milestones for participating sites, ensuring alignment with clinical trial protocols and regulatory requirements
Collaborate with the Principal Investigator (PI) to develop protocols and consent forms for initial applications and amendments, ensuring they meet regulatory requirements and are easily understood by participants
Ensure the project team meets all deadlines and maintains ongoing relationships with the research team, Principal Investigators, and external collaborators
Develop systems, tools, and infrastructure for clinical trial management activities, including study start-up, site activation, research staff training, regulatory submissions, and event tracking
Prepare and present detailed status reports to key stakeholders, including information about project timelines, progress, and compliance with regulatory standards
Qualification
Required
Bachelor's degree in a field relevant to clinical research
Five (5) years of experience in clinical research or project management, with a focus on multi-center oncology trials, including specific experience in clinical trial operations and coordination
In-depth understanding of clinical trial phases and multi-center trial coordination, including specific requirements for PI-initiated trials
Knowledge of advanced regulatory requirements and compliance standards, with expertise in Good Clinical Practice (GCP) and FDA regulations
Familiarity with project management methodologies and strategic planning, tailored to clinical trial environments
Advanced organizational skills to manage multiple complex projects simultaneously, ensuring compliance and efficiency in trial execution
Strong leadership and team coordination skills to guide research teams, with the ability to mentor junior staff and foster collaboration
Proficient in developing project plans and tracking systems, utilizing clinical trial management software such as EPIC and OnCore
Ability to work independently with minimal supervision, while ensuring adherence to clinical trial protocols and regulatory standards
Capability to develop and implement strategic project management solutions, optimizing trial processes and resource allocation
Competence in stakeholder engagement and relationship management, including effective communication with regulatory authorities and external partners
Expertise in risk assessment and contingency planning to address potential trial challenges and ensure project milestones are met
Ability to analyze complex data sets and generate actionable insights to inform trial decisions and improve outcomes
Preferred
Experience in an academic institution with a proven track record of success in the clinical research field, particularly in roles involving leadership and strategic management of clinical trials
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
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