Director, Office of Data Quality-Clinical Research

Overview

This position's work location is fully remote with occasional onsite time as needed. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI).

The Director of the Office of Data Quality, plays a pivotal role in supporting Clinical Research for Dana-Farber/Harvard Cancer Center (DF/HCC) and Dana-Farber Cancer Institute. The primary purpose of the Office of Data Quality is to develop, maintain, implement and continuously improve a program that supports the highest standards of data quality in clinical research. The Director is responsible for the oversight of clinical research auditing across the DF/HCC consortium, support for the DF/HCC Data Safety Monitoring Board/Committee as well as maintenance of the Data Safety and Monitoring Plan, quality improvement processes, quality control of eCRFs and other CTMS data and oversight of Standard Operating Procedures and Working Instructions.

Reporting to the VP, Clinical Research Management Dana-Farber Cancer Institute/Dana-Farber/Harvard Cancer Center, the Director will also work closely with the DF/HCC Medical Director for Clinical Trials. The Director of the Office of Data Quality will also interact closely with other DF/HCC and DFCI offices that support clinical research including: Clinical Trials Research Informatics Office, Office of Human Research Subjects, Clinical Trials Offices from all DF/HCC consortium sites, and DF/HCC Administration. The Director is supported by an experienced team of approximately 15 - 17 FTEs.

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.

Responsibilities

• Manage the day-to-day operations of the various functional areas within Data Quality, including audit, clinical trial reporting such as CTRP program and CT.gov, quality improvement, eCRF and other CTMS quality control, and DSMC and DSMB support.
• Manage and oversee institutional data quality related committees such as Audit Committee and Data Safety Monitoring Committee
• Manage audit and monitoring data to track and trend metrics for use in the systematic identification and resolution of issues
• Create and oversee feedback mechanisms for quality improvement
• Identify needs for additional policies, practices and/or initiatives within Data Quality
• Serve as a mentor to Data Quality staff, overseeing and supporting professional growth, evaluating their performance as appropriate and improving the quality of their work.
• Participate on various institutional and DF/HCC research committees as determined in consultation with the Associate Director for Administration for DF/HCC. Potential committee involvement includes the following:
• Clinical Sciences Coordinating Committee
• Clinical Investigations Leadership Committee
• Clinical Operations Committee
• Audit Committee
• Data Safety Monitoring Committee
• Research Administrative Leadership Team
• DF/HCC SOP Working Group
• Steering Committee of Harvard/Catalyst QA/QI Development Committee
• Represent the department by active participation in national cancer center meetings, including preparation and submission of abstracts, posters, or presentations.
• Enhance and facilitate communications between Data Quality and other departments within DF/HCC and DF/HCC consortium members
• Assist the Associate Director for Administration with related projects, such as the development of tracking or related databases

SUPERVISORY RESPONSIBILITIES:

The Director will have approximately five direct reports and approximately 15 - 20 indirect reports, and managerial personnel overseeing the various functional areas of Data Quality, including audit, clinical trial reporting, quality improvement, eCRF quality control, and DSMC & DSMB support.

The Director will have the following decision-making authority:

• Human resources issues
• Budget and salary issues
• Resource allocation

Qualifications

• Bachelor's degree required; Master's or other advanced degree preferred
• 5 - 7 years clinical trials experience, oncology research preferred
• 3 - 5 years experience in management, including supervisory and training experience

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• An understanding of relevant Federal and State regulations and guidelines on research involving clinical research
• Auditing and monitoring experience in a clinical research environment
• Track record of implementing quality improvement plans and effecting change
• Prior experience or familiarity with NCI Cancer Centers program and Cancer Center Support Grant Guidelines
• Exceptional communication, problem-solving, consensus building and leadership skills. Highly effective interpersonal skills, a sensitivity to-and an understanding of-the operational issues that must be addressed in the management of a complex research function
• Ability to work in a complex consortium environment
• Experience working in a team-oriented, collaborative environment
• Ability to assess strengths and weaknesses, prioritize response, and set strategic direction and effect change
• Strong leadership skills

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 characteristics protected by law.

EEOC Poster