This position will work within the clinical research program and manage the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Trials Office.?? The Senior Clinical Research Program Manager, in collaboration with the Center for Cancer Therapeutic Innovation (CCTI) program???s physicians and research nursing staff, will be responsible for the design, implementation and evaluation of this program???s clinical research activities (therapeutic and non-therapeutic), all related regulatory and compliance oversight, and direct supervision of their program???s clinical research staff.?? The Senior Clinical Research Program Manager is responsible for tracking and complying with clinical trial & Institutional performance benchmarks; e.g. protocol applications and other submissions in IRIS, protocol and regulatory compliance, patient safety, staff development & training and financial goals, as defined by Senior Research Leadership and the DFCI Clinical Trials Office.
Center for Cancer Therapeutic Innovation (CCTI)
The Senior Clinical Research Program Manager (SCRPM) will be responsible for the overall operations, regulatory compliance, data management, clinical trial monitoring and hiring, supervision and training of research staff for the CCTI.?? In addition, will be responsible for supporting the primary goals of the CCTI; assisting senior Physician leadership, the Alliance Program Manager and CORE Faculty to unite the Phase I, multi-malignancy trials under one umbrella, to assist on external engagement and cross-malignancy, early clinical and translational research.??
Overall scope, specific program initiatives, and required competencies include; the ability to initiate and execute the mission of the CCTI???s primary goals; create, develop and implement an infrastructure to support the overall missions??? goals, to build and maintain a new and innovative clinical program that supports and enhances this new initiative.?? The SCRPM must have the ability to lead and provide the motivation and direction that equals success.????
Clinical Trials Operations
The Senior Clinical Research Program Manager will be responsible for the oversight of the disease group???s clinical trial portfolio and all related regulatory, compliance and performance metrics requirements.
Will oversee the processing of protocols through DFCI Institutional Review Board (and other institutions??? IRBs) when appropriate. The SCRPM will collaborate with the DFCI Clinical Trials Office (CTO), the Office for Human Research Studies (OHRS), and the Office of Data Quality (ODQ) to fulfill local and federal requirements governing human clinical trials.
Will Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution.
Will assist the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and Contracts offices. Work with grant managers and other financial managers in the reporting and accounting of these funds.
Oversees and coordinates the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials.
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.
Assists the principal investigator in preparing manuscripts for publication.
Collaborate with the DFCI CTO, and DF/HCC ODQ to develop study forms, database information, and to establish guidelines for monitoring data quality control for PI Initiated studies / Multi-Center Trials
Oversee the subject enrollment, protocol treatment and follow-up care processes for protocol patients.
Oversees registration of protocol patients with ODQ or OnCore policies and pharmaceutical company as outlined in protocol.
Regulatory & Compliance
Assumes responsibility for essential document compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance.??
Assumes responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations etc. Implements systems to monitor portfolio compliance.
Responsible for the disease group???s transition from paper to electronic regulatory binders. Will maintain per DFCI CTO standards.????
Data Management & Clinical Trial Monitoring
Assumes responsibilities for data management and compliance for entire portfolio. Maintains schedules and procedures necessary for timely and complete data collection.
Regularly reports data compliance status to key stakeholders; i.e. DFCI PI, study Sponsor, DFCI CTO. Implements corrective action to maintain data compliance when necessary.
Submits required ???progress / tracking??? reports to key stakeholders, when applicable.
Staff Hiring, Supervision, Training & Development
Responsible for the recruitment and oversight of all of the research staff. Ensure that all staff complete required mandatory and ongoing training in a timely manner. Develops and oversees a program specific on-boarding and orientation process and conducts annual performance evaluations and competency assessments of research staff.
Develops a standard supervision schedule with research staff including periodic individual and group supervision meeting. Will develop and agenda, take attendance and document all applicable meetings.
Will communicate all personnel concerns to their immediate supervisor and to DFCI HR partner for the appropriate response and follow up.
Senior Clinical Research Program Manager:
Must be competent in all the above.?? Has expert knowledge of and is fully proficient in ability to execute clinical trials start-up, active and close out phases.?? Is fully proficient in their knowledge of clinical research local policy and federal regulation. Strong ability to independently navigate complex personnel issues in collaboration with key stakeholders. Can navigate and or interpret complex regulatory strategy and can operationalize when applicable with little or no supervision.?? Operates proactively to maintain compliance and best practice.?? Able to problem solve and work collaboratively with key stakeholders. May be asked to provide in-service training and can serve as a resource to other clinical personnel including physicians, nurses, pharmacists and other allied health professionals regarding clinical trials, protocols, GCP guidelines, federal regulations and site SOPs.
SUPERVISORY RESPONSIBILITIES: (include number of direct reports)
Supervises study management staff, including clinical research coordinators, students, volunteers, and other research assistants. Number of Direct Reports 10+
MINIMUM JOB QUALIFICATIONS: (Education, certifications, years of experience)
Bachelor???s Degree required, with a minimum of 10 + years of related experience or master???s degree with 5+ years??? experience.????
KNOWLEDGE, TECHNICAL SKILLS, AND ABILITIES REQUIRED: Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.?? In addition, has experience in protocol development, data compilation and analysis.?? The Manager will be skilled at developing tracking systems to ensure timely data management by the clinical research staff.?? They will also have expert knowledge of Federal and State regulations as they relate to research.?? Strong interpersonal, organizational and communication skills are required.?? Must have computer skills including the use of Microsoft Office and working knowledge of Livelink; EPIC and OnCore applications.
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 underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
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.
Internal Number: 2021-24282
About Dana-Farber Cancer Institute
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.