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Clinical Trial Research Project Manager

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.

 

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 collaboration with faculty investigators and the research team is responsible for overseeing national/and or institutional 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.   
  • 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

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.

EEOC Poster

Average salary estimate

$97500 / YEARLY (est.)
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$85000K
$110000K

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What You Should Know About Clinical Trial Research Project Manager, Dana-Farber Cancer Institute

Are you ready to take on an exciting challenge as a Clinical Trial Research Project Manager at Dana-Farber Cancer Institute in Boston, Massachusetts? In this pivotal role, you'll be the go-to person for coordinating the day-to-day activities of multi-center, PI-initiated clinical trials. Imagine being at the heart of groundbreaking cancer research where you will manage everything from startup activities to training site staff and ensuring compliance with all regulatory protocols. Your organizational skills will shine as you track safety events, violations, and participant accrual. Here at Dana-Farber, we thrive on collaboration and you'll find yourself working closely with esteemed faculty, research coordinators, and various stakeholders to drive our mission of conquering cancer. With oversight responsibilities, you will also develop infrastructure and procedures for project management, making sure that every trial is executed to the highest standard. You will be part of a dynamic team that promotes inclusivity in a fast-paced environment, ensuring that every patient's journey is handled with the utmost care. If you have a Bachelor’s degree related to clinical research and at least 5 years of relevant experience, coupled with the ability to juggle multiple projects independently, this might just be the role for you! Join us in making a positive impact on cancer research and patient care!

Frequently Asked Questions (FAQs) for Clinical Trial Research Project Manager Role at Dana-Farber Cancer Institute
What are the primary responsibilities of a Clinical Trial Research Project Manager at Dana-Farber Cancer Institute?

As a Clinical Trial Research Project Manager at Dana-Farber Cancer Institute, your primary responsibilities will include coordinating trial startup and site startup activities, training site research staff, managing regulatory submissions, tracking safety events, and overseeing participant accrual. Additionally, you'll be managing communication with various stakeholders, ensuring project milestones are met, and developing reporting systems for clinical research activities.

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What qualifications are necessary to become a Clinical Trial Research Project Manager at Dana-Farber?

To become a Clinical Trial Research Project Manager at Dana-Farber Cancer Institute, candidates should hold a Bachelor’s degree in a relevant field like clinical research and possess at least 5 years of experience in project management, specifically in multi-center oncology trials. A strong understanding of regulatory affairs and the ability to work independently are also crucial for this role.

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How does Dana-Farber ensure compliance in clinical research managed by the Clinical Trial Research Project Manager?

Dana-Farber Cancer Institute ensures compliance in clinical research through rigorous oversight and management by the Clinical Trial Research Project Manager. This includes developing and implementing procedures that align with regulatory requirements, tracking deviations and violations, and maintaining high-quality data collection processes throughout the project lifecycle.

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What kind of team dynamics can a Clinical Trial Research Project Manager expect at Dana-Farber?

A Clinical Trial Research Project Manager at Dana-Farber can expect a dynamic and collaborative team environment. You'll work closely with faculty, clinical coordinators, and various departments to promote accountability and cohesion, ultimately contributing to impactful cancer research initiatives.

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What role does the Clinical Trial Research Project Manager play in patient contact at Dana-Farber?

The Clinical Trial Research Project Manager at Dana-Farber may have direct contact with patients of all ages and backgrounds. This role involves determining patient eligibility for clinical trials and supporting the recruitment, consenting, and enrollment processes, ensuring that all patient interactions are handled with care and professionalism.

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Common Interview Questions for Clinical Trial Research Project Manager
Can you describe your experience with managing clinical trials in an oncology setting?

When answering this question, highlight specific trials you've managed, discussing your role in coordination, regulation, and oversight. Emphasize your experience with multi-center trials and any direct interactions with patients or research staff, showcasing your leadership and organizational capabilities.

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How do you ensure compliance with regulatory requirements in clinical trials?

In your response, discuss systematic approaches you take to maintain compliance, such as thorough review processes for regulatory submissions and regular training for research staff. Mention your familiarity with regulatory guidelines and how you keep the team informed about updates or changes.

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What project management tools or methodologies are you familiar with?

Share specific project management tools that you have utilized in your previous roles. Discuss methodologies such as Agile or Waterfall, and explain how you adapt these tools to suit the needs of clinical trials, ensuring that all timelines and milestones are effectively met.

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Describe a challenging project you managed and how you handled it.

Narrate a specific instance where you faced challenges in project management. Discuss the problems encountered, the steps you took to address them, and the successful outcomes that resulted from your efforts, showcasing your problem-solving skills and resilience.

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How do you track participant accrual in clinical trials?

Discuss the methods you use for tracking participant accrual, such as databases or management software. Also, include how you communicate accrual status with stakeholders and adjust strategies to improve recruitment when necessary.

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How do you coordinate training for new research staff?

Explain your approach to onboarding and training new staff, covering the importance of comprehensive training programs that incorporate both regulatory knowledge and practical expertise. Discuss how you create supportive environments that foster learning and growth.

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What strategies do you use for effective communication with key stakeholders?

Describe your techniques for fostering open communication, such as regularly scheduled meetings and updates, using user-friendly project management tools, and your overall philosophy regarding stakeholder involvement throughout the trial process.

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What is your approach to managing multiple clinical trials simultaneously?

Highlight your time management skills and prioritization strategies. Discuss tools or processes you utilize to balance various projects while maintaining quality control and ensuring that all trial milestones are met without compromising standards.

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How do you handle deviations and violations in clinical trials?

Elaborate on your procedures for identifying and documenting deviations and violations, including how you communicate these issues proactively to the relevant teams. Discuss your approach to implementing corrective actions to prevent future occurrences.

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Why do you want to work at Dana-Farber Cancer Institute as a Clinical Trial Research Project Manager?

Reflect your passion for cancer research and patient care. Emphasize Dana-Farber's commitment to innovation and inclusivity, and how these values align with your professional aspirations and personal principles in the clinical research field.

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The Dana-Farber Cancer Institute fights cancer on two fronts: It provides treatment to cancer patients, young and old, and researches new cancer diagnostics, treatments, and preventions. The organization's scientists also research AIDS treatments ...

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DATE POSTED
March 29, 2025

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