The Senior Clinical Research Program Manager oversees the ongoing development, operations, and regulatory compliance of their assigned portfolio. Reporting to faculty, research and/or disease group managers, and/or Clinical Trials Office (CTO) leadership, the Senior Clinical Research Program Manager is responsible for the design, implementation and evaluation of the assigned team’s clinical research activities, all related regulatory and compliance oversight, and direct supervision of their program’s clinical research staff. 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 a high level of autonomy and independence, with a strategic focus on enhancing trial efficiency, compliance, and stakeholder engagement.

The Program Manager in Pediatric Oncology works in partnership with the Principal Investigator (PI) to develop a long-term strategic plan to more efficiently manage tissue-based research projects, clinical research operations, collaborations, and regulatory approval. The position is also involved in the development of the first of its kind pediatric-specific liquid biopsy test for clinical return of results.

Due to the nature of this position with clinical research:

• Previous experience in the conduct of clinical trials and research operations preferred.Â
• Experience in human subject regulatory management and management of specimen-based research preferred.
• Bachelor’s degree in cancer, genetics, genomics, or research preferred.

Duties specific for this Program Manager role:

• Responsible for regulatory management for the Lab by drafting, submitting and maintaining regulatory approval for biology protocols originating from the Crompton Lab.
• Responsible for management of ongoing grants and projects within the lab, including tracking, drafting and submitting progress reports, tracking milestones and tracking of project invoices and payments.
• Responsible for sample selection and working with vendors to obtain purchase orders and completing invoicing.
• Coordinate work between collaborators involved in PI-initiated consortiums and projects
• Work on “special projects” that may include support for the pediatric solid tumor program where the hiring PI has research leadership roles.
• Contribute creatively and scientifically to grant applications, project reports, manuscript preparation, and IRB applications.
• 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.

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.

Minimum Education Requirement:
Bachelor’s degree in a field relevant to clinical research required; a master’s degree is preferred.

Minimum Experience Requirement
•Nine (9) years of experience in clinical research or project management, including leadership roles, with extensive experience inoverseeing complex, multi-center trials and strategic planning, preferably within the CTO environment.
•Must demonstrate a proven history of success in the clinical research field, preferably within an academic institution, with a focus onclinical trial operations and regulatory compliance.

Knowledge, Skills & Abilities
•Expert understanding of clinical research operations and strategic management, with a focus on multi-center clinical trials and regulatorycompliance.
•Expertise in protocol development, study design and data analysis, including the ability to ensure alignment with Good Clinical Practice(GCP) and FDA regulations.

Strong knowledge of innovative project management practices, specifically tailored to the clinical trials landscape.
•Expert leadership skills to oversee and mentor project managers and research teams, fostering a culture of compliance and excellence in clinical trial execution.
•Expertise in analytical skills for interpreting complex data and making informed decisions, with the ability to synthesize insights into actionable strategies for trial optimization.
•Advanced in protocol writing and research documentation, ensuring accuracy and compliance with regulatory standards.
•Ability to work autonomously and make high-level decisions impacting clinical trial operations, while maintaining alignment with organizational goals and strategic priorities.
•Capability to lead cross-functional teams and integrate clinical trial activities with organizational goals, ensuring seamless collaboration and resource allocation.
•Competence in driving continuous improvement and innovation in clinical trial management practices, leveraging technology and best practices to enhance trial efficiency and outcomes.
•Expertise in stakeholder engagement and relationship management, including effective communication with regulatory authorities, external partners, and key stakeholders.

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 equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

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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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