Senior Research Project Manager - Clinical Trials Office
Dana-Farber Cancer Institute
Location: Boston, Massachusetts
Internal Number: 2023-32068
The Research Project Manager (RPM) is responsible for assigned day-to-day coordination and overall management of sponsor activities for assigned clinical trials; primarily multi-center, PI-initiated trials. Sponsor activities include coordinating trial startup and site startup activities, providing training to participating site research staff, regulatory submissions, safety event tracking and reporting, deviation/violation tracking and reporting, participant accrual tracking and reporting, conducting teleconferences, vendor management, coordinating communication with regulatory authorities and manufacturers, etc. The RPM will be responsible to report on his or her defined deliverables, to identify variances in project plan and to develop contingency plans when necessary to keep project milestones on track. The RPM will have a dual report in to their disease group manager and PIs and to CTO Leadership to develop and implement strategies that will ensure compliance, consistency, and accountability in all assigned clinical research activities conducted at DFCI. Specific tasks and responsibilities are varied and dependent upon project aims, scope and duration.
A Research Project Manager may also be assigned to oversee various operational and training aspects of the EPIC / OnCore application used by the DFCI Research Enterprise. The RPM will work closely and collaboratively with a variety of faculty and staff at all levels throughout DFCI/BWH, and also will work in collaboration with the OnCore IS team and other key stakeholders. The RPM will develop infrastructure, procedures, and tracking systems for project management services performed. Project management responsibilities would include coordinating the on boarding of new research staff training, maintaining workflows, facilitating all questions related to OnCore and defining grant and research specific reporting for the DFCI. The RPM will be supervised and supported by the Director of Operations to develop and implement strategies that will ensure compliance, consistency, and accountability in all assigned clinical research activities conducted within the system at DFCI. This individual is responsible for creating a proactive, knowledgeable and cohesive project management platform that will support the research community.
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.
Responsible for day-to-day oversight and management of assigned projects.
Responsible for development and maintenance of Trial Master File (TMF),
Assists PI with protocol and consent form development for initial application and with subsequent amendment changes.
Initiates, plans, facilitates and oversees the research project start-up, active and close out phases; for PI Initiated / Multi Center.
Responsible for Case Report Form design with PI directives. Maintain study-related databases, and prepare protocol-related reports as needed.
May be responsible for scheduling research team meetings and conference calls, facilitating mailings and other project-related administrative tasks.
Oversee the coordination, execution and overall management of several Phase I, II, III PI-Initiated / Multi-Center oncology trials.
Assist senior manager(s) in the development of a project plan that serves as a guiding document that provides overall direction, expectation of deliverables and stated milestones for the participating sites to ensure the success of the project.
Responsible for assuring that the project team meets all deadlines and is also to maintain an ongoing working relationship with Research team and Principal Investigators.
Responsible for developing the systems, tools, and infrastructure needed for project management core activities, including study start-up activities, coordinating and managing site activation, research staff training, regulatory submissions, event tracking and reporting, deviation and violation tracking and reporting, participant accrual tracking and reporting.
Prepares and presents status reports to key stakeholders. Depending on project needs, these reports may include information about project timelines, status of deliverables, and/or resources requirements
In addition to performing the above responsibilities, this position will require a high level of autonomy and independence and will also be responsible for some or all of the below:
Maintains overall responsibility and major decision-making authority for day-to-day operations and supervision of research group, which may include Research Project Managers I and II.
Collaborates closely with investigators to develop, design, and implement research protocols, study procedures, data analysis plans and data use agreements.
Oversees project reporting and interprets more complex data analyses.
Contributes significantly to design of studies and assists with protocol writing, manuscript drafting and grant preparation, including writing sections of such materials.
Assumes leadership responsibility for managing a complex, multi-center research project.
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.
Master???s degree with 5 years experience preferred, or Bachelor???s with 7 years experience of multi-project management.
Ability to lead multiple projects. Ability to oversee all aspects of project management scope defined deliverables and required key performance standards.
Must demonstrate a history of proven success in the clinical research field.
Experience in an academic institution is preferred.
Must have expert knowledge of regulatory affairs, research ethics and the responsible conduct of research. Supervisory experience required.
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 groups as protected by law.
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to under-served members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.