Clinical Research Project Manager

The Clinical Research Project Manager II manages day-to-day coordination and overall clinical trial activities for the Psychedelic-Assisted Therapy (PAT) Research Program within the Department of Supportive Oncology. This role oversees the full lifecycle of complex, single or multi-center clinical trials, including Principal Investigator (PI)–initiated trials, NIH-funded (e.g., UG3/UH3), and industry-sponsored studies focused on psychedelic-assisted therapies for individuals with advanced cancer and serious illness.

The Clinical Research Project Manager II oversees trial startup coordination, trains site research staff, handles regulatory submissions, tracks safety events, and communicates with regulatory authorities. The Clinical Research Project Manager II identifies project plan variances and develops contingency plans to maintain project milestones. They may also oversee operational and training aspects of the EPIC/OnCore application, collaborating with faculty, staff, and stakeholders to develop infrastructure and procedures.

This role requires increased independence and less supervision, with an emphasis on optimizing trial processes and ensuring adherence to regulatory standards.

This is a full-time, 40-hour per week position. As a hybrid role, the schedule includes 2-3 days of on-site work at the DFCI Longwood location. DFCI guidelines state that employees must reside in New England:
Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, or Vermont.

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.

We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

• Advanced Project Management:
  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. This requires strategic planning, adaptability to changing project needs, and the ability to manage complex trial logistics.
• Project Plan Development:
  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. This structured planning is crucial for the successful execution of trials.
• Protocol and Consent Form Development:
  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. This requires strong understanding of regulatory requirements and research design.
• Team Coordination and Relationship Management:
  Ensure the project team meets all deadlines and maintains ongoing relationships with the research team, Principal Investigators, and external collaborators. Effective communication and collaboration are essential to ensure compliance and successful trial outcomes.
• Infrastructure Development:
  Develop systems, tools, and infrastructure for clinical trial management activities, including study start-up, site activation, research staff training, regulatory submissions, and event tracking. This enhances efficiency, compliance, and effectiveness in trial execution.
• Status Reporting:
  Prepare and present detailed status reports to key stakeholders, including information about project timelines, progress, and compliance with regulatory standards. This keeps stakeholders informed and engaged in the project's development, ensuring transparency and accountability.

• Supervises…