Clinical Research Project Manager

Overview

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.

Primary Duties and Responsibilities:

• 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.

Knowledge, Skills and Abilities:

• 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.

Minimum Job Qualifications:

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.
Experience in an academic institution with a proven track record of success in the clinical research field is preferred, particularly in roles involving leadership and strategic management of clinical trials.

Supervisory Responsibilities:

Yes

Patient Contact:

No

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.

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Pay Transparency Statement

The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications.

For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).

$97,770.00 - $103,345.00