Clinical Research Project Manager - Thoracic Oncology

Dana-Farber Cancer Institute is a cancer research and patient care organization focused on advancing treatment and reducing the burden of cancer. The Clinical Research Project Manager coordinates and manages Thoracic Oncology clinical trials, including site start-up, regulatory submissions, trial documentation, safety tracking, and project milestones. The role also supports clinical trial systems, databases, training, and administrative coordination while ensuring regulatory compliance and efficient trial execution.

Responsibilities

Day-to-Day Project Oversight: Manage the daily operations of assigned clinical trials, ensuring efficient execution and adherence to timelines while maintaining compliance with clinical trial regulations. This involves monitoring budgets, resources, and coordinating with cross-functional teams to meet project milestones

Trial Master File (TMF) Development and Maintenance: Develop and maintain the TMF, ensuring all essential documents are organized, accessible, and compliant with Good Clinical Practice (GCP) standards. Regular updates are conducted to ensure compliance with regulatory standards and institutional policies

Protocol and Consent Form Development: Assist the Principal Investigator (PI) in developing protocols and consent forms for initial applications and amendments, ensuring they meet regulatory requirements and are easily understood by participants. This requires translating complex scientific concepts into clear, concise documents

Clinical Trial Phases Management: Initiate, plan, and oversee the start-up, active, and close-out phases of clinical trials, particularly for PI-initiated and multi-center studies. Coordination with stakeholders, including site staff and external partners, ensures smooth transitions between phases and adherence to timelines

Case Report Form Design and Database Maintenance: Design case report forms based on PI directives and maintains study-related databases, ensuring data integrity and compliance with clinical trial standards. Prepare protocol-related reports and data summaries to support ongoing research activities and decision-making

Administrative Support: Schedule research team meetings and conference calls, facilitate mailings, and perform other project-related administrative tasks to ensure effective communication and coordination among team members and external collaborators

Preferred

preferably in a field relevant to clinical research

ideally within multi-center oncology trials

Multicenter Trials

Oncology Trials

Benefits

Fully remote work, 100% off site; the selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI).

Company

Cancer treatment and research institute for children and adults

Boston, Massachusetts, USA

http://www.dana-farber.org/

Founded in 1947

1001-5000 employees

Qualifications

Basic understanding of clinical trial processes and regulatory requirements, including Good Clinical Practice (GCP) guidelines

Familiarity with trial management software and tools, such as EPIC and OnCore, for efficient trial coordination

Awareness of data management practices and documentation standards, with an emphasis on compliance and accuracy

Strong organizational and time management skills to handle multiple tasks efficiently, ensuring adherence to clinical trial timelines

Effective communication skills for interacting with research staff, stakeholders, and regulatory authorities

Basic problem-solving skills to address project-related issues, with the ability to anticipate and mitigate potential challenges

Ability to work independently under general supervision, while maintaining compliance with clinical trial protocols

Capability to learn and adapt to new procedures and technologies, including updates in clinical trial regulations

Competence in maintaining accurate records and documentation, ensuring compliance with regulatory standards

Understanding of ethical considerations and patient confidentiality in clinical trials

Ability to collaborate effectively with cross-functional teams and external partners to support trial objectives

Bachelor's Degree required

Three (3) years of experience in clinical research or project management, ideally within multi-center oncology trials, with specific experience in managing clinical trial operations

Preferably in a field relevant to clinical research

Ideally within multi-center oncology trials

Three (3) years of experience in clinical research or project management, ideally within multi-center oncology trials, with specific experience in managing clinical trial operations.

Required skills

Clinical trial operations, Clinical Practice (GCP), EPIC, OnCore, Clinical trial data management, Clinical trial regulatory compliance, Trial Master File (TMF) management, Case report form design, Multi-center oncology trials

Preferred skills

preferably in a field relevant to clinical research, ideally within multi-center oncology trials

Experience

3+ years