National War College Alumni Association

The Senior Clinical Research Manager for Populations Sciences will be responsible for overseeing the development and implementation of best practices for clinical research within Dana-Farber???s Medical Oncology Division of Population Sciences and the McGraw Patterson Center for Population Sciences. This position will report to the faculty Clinical Research Director for Population Sciences and work closely with the Chief of the Division of Population Sciences and the Department Administrator.

In conjunction with Division/Center leadership, the Senior Clinical Research Manager will assist in developing a formal clinical research infrastructure within the Division and Center. They will work with key stakeholders on strategic planning activities related to clinical research operations, policies, procedures, and processes. In addition, the Senior Clinical Research Manager will be responsible for streamlining education and training for new clinical research staff.??They will act as a direct liaison between a multi-disciplinary group of Population Sciences investigators and their research teams, the DFCI Clinical Trials Office (CTO), Office of Human Research Studies (OHRS) and the Office for Data Compliance (ODQ). The Division/Center???s existing clinical research portfolio includes a wide range of clinical research studies focusing on cancer care delivery, outcomes, genetics and prevention, equity and disparities, energy balance, ethics, computational oncology, global oncology, and community-based research.

The Senior Clinical Research Manager will be responsible for tracking and complying with clinical trial and institutional performance benchmarks and metrics such as IRB protocol applications, amendments, and other submissions in IRIS and OncDRS, protocol and regulatory compliance, patient safety, staff development/training and Division/Center financial goals, as defined by Dana-Farber senior research and clinical operations leadership.

This position may also include oversight and support of a specific clinical research program within Population Sciences. Working in close alignment with Division/Center leadership, the applicant may help manage a clinical research team (clinical research coordinators and/or research assistants). For this function, the Senior Clinical Research Manager, in collaboration with Division of Population Sciences investigators and research staff, will be responsible for the design, implementation and evaluation of clinical research activities (therapeutic and non-therapeutic), all related regulatory and compliance oversight, and supervision of that team???s research???s staff.??

Clinical Research Operations

• Serve as primary point of contact in resolving staff and care delivery issues.
• Partner across all service delivery lines to ensure seamless operations.
• Participate and build quality assurance project teams.
• Communicate and share information regularly with Dry Lab Research teams.
• Routinely monitor and address new patient access metrics.
• Review all Clinical Statistics Reports and report out to Division Leadership.
• Maintain and regularly report out on the financial portfolio of operating, grant, clinical trial, and discretionary/gift accounts.
• Senior Clinical Research Manager will be responsible for the oversight of the division???s clinical research portfolio and all related regulatory, compliance and performance metrics requirements.

• The Sr. Clinical Research Manager will oversee the processing of protocols through DFCI Institutional Review Board (and other institutions??? IRBs) when appropriate. This position will collaborate with the CTO, the OHRS, and the Office of Data Quality (ODQ) to fulfill local and federal requirements governing human clinical trials.

• Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution.

• Assist the principal investigator in developing the protocol budget and subsequent reporting, in collaboration with Research Administrators and the Clinical Trials Business Office.

• Oversees and coordinates the purchase, receipt, inventory, and distribution of supplies utilized in the conduct of clinical trials.

• In collaboration with the research administrators, may maintain, monitor, and reconcile all study and related finances. These may expenditure tracking, procurement, salary worksheets and staffing.

• May assist the principal investigator in preparing manuscripts for publication.

• Collaborate with the 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 subject enrollment, protocol treatment and follow-up care processes for protocol patients.

• Oversee 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.

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.

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Staff Hiring, Supervision, Training & Development

• Responsible for the recruitment and oversight of research staff. Ensure that all staff complete required mandatory and ongoing training in a timely manner. Develop and oversee program specific on-boarding and orientation process and conduct annual performance evaluations and competency assessments of staff.

• Develops a standard supervision schedule with research staff including periodic individual and group supervision meetings. Will develop and agenda and document all applicable meetings.

• Will communicate all personnel concerns to their immediate supervisor and to the DFCI HR business partner for the appropriate response and follow up.

• Bachelor's Degree required, with a minimum of 7+ years of related experience or Master Degree with 5+ years experience.??
• Must be able to perform day to day responsibilities independently with little or no supervision from manager. Has very proficient knowledge of and ability to execute clinical trials start-up, active and close out phases. Has very proficient knowledge of clinical research local policy and federal regulation. Can easily identify complex regulatory scenarios, independently develops viable solutions to present to supervisor. Must be very proficient in the ability to manage personnel issues and to provide critical feedback to supervisees, when applicable.
• 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 to 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.
• 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.

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.

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.

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