Clinical Trial Research Project Manager

Dana-Farber Cancer Institute

Boston, MA

Job posting number: #7305065 (Ref:df43824)

Posted: March 28, 2025

Job Description

The Research Project Manager II (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.

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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.

This position in collaborationÂwith faculty investigators and the research team is responsible for overseeing national/and orÂinstitutional projects related to cancer prevention, early identification of individuals with cancer, and biorepository collections. This position is also responsible for data collection and management, and overall project management of national and/or institutional databases. This position requires familiarity and experience managing multiple projects, will require the individual to work on an increasingly independent basis with minimal supervision, and will include the supervision of clinical research coordinators.

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 the creation and maintenance of research studies including the design, creation and implementation of protocols and procedures for required data updates and biospecimen collections, in compliance with required regulatory and institutional policies.
  • Responsible for the development of data presentation slides for meetings and conferences on supported projects.
  • Consults with and advises programmers and project staff on data issues during project development and implementation.
  • Determines patient eligibility, including data extraction from electronic medical records and may be responsible for recruitment, consenting and enrollment of study participants.
  • Responsible for IRB submissions, correspondence, and regulatory binders, including administrative amendments.
  • Designs processes for maintaining timely, complete and high-quality data collection.
  • May be responsible for scheduling research team meetings and conference calls, facilitating mailings, maintaining project timelines, and other project-related administrative tasks.
  • May be responsible for specimen management, depending on assigned projects.
  • Oversee the coordination, execution and overall management of several II PI-Initiated / Multi-Center oncology trials.
  • Assist 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.ÂÂÂ
  • 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.ÂÂÂ
  • 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

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.

  • Bachelor’s degree required in a field relevant to clinical research, and 5 plus years experience with project management and experience working on clinical trials (multi-center, oncology trials preferred).
  • Experience in an academic institution and proven history of success in clinical research field is preferred.
  • Must have the ability to function independently.
  • Must have strong knowledge of regulatory affairs, research ethics and the responsible conduct of research.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

  • Strong attention to detail, organizational, communication and interpersonal skills.
  • Excellent ability to work independently and balance multiple projects and tasks simultaneously.
  • Ability to work as a member of a team and proactively lead teams.

SUPERVISORY RESPONSIBILITIES: Potential staff to include: Clinical Research Coordinators

PATIENT CONTACT: May have contact with patients of all ages and populations

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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More Info

Job posting number:#7305065 (Ref:df43824)
Application Deadline:Open Until Filled
Employer Location:Dana-Farber Cancer Institute
Needham,Massachusetts
United States
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