Director, Office of Data Quality-Clinical Research

Overview

This position's work location is remote with occasional time onsite 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 Human Subject Research for Dana-Farber/Harvard Cancer Center (DF/HCC) and Dana-Farber Cancer Institute. The primary purpose of the Office of Data Quality (ODQ) 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 DF/HCC policies and procedures.

Reporting to the VP Clinical Research Management Dana-Farber/Harvard Cancer Center, the Director will also work closely with the DF/HCC Associate Director of Clinical Trials and DF/HCC Medical Director(s). The Director of the Office of Data Quality will also interact closely with other DF/HCC and DFCI offices that support clinical research including Research Informatics and Operations, Office of Human Research Studies, Clinical Trials Offices from all DF/HCC consortium sites, and DF/HCC Administration. The Director is supported by an experienced team of approximately 26-30FTEs.

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 Office of Data Quality, including:
  • Internal auditing and administrative support of the DF/HCC Audit Committee
  • Implementation of the DF/HCC Data and Safety Monitoring plan and administrative support of the DF/HCC DSMC and DF/HCC DSMB
  • Clinical trial reporting to NCI CTRP and Clinicaltrials.gov
  • Quality control and governance of CRF data in DF/HCC Inform EDC
  • Quality control of subject registrations and operational data in the OnCore CTMS
  • Feasibility review and activation of submissions in the iRIS PRMS
  • Maintenance of DF/HCC policies and procedures
  • DF/HCC educational initiatives, training sessions, educational resources, and e-learning library
• Monitor, track, and report to DF/HCC leadership on trend metrics related to DF/HCC quality and operations (e.g., audit observations, activation timelines, Clinicaltrials.gov compliance).
• Create and oversee feedback mechanisms to identify opportunities for quality improvement. Lead process improvement initiatives that may include updating policies, practices and/or informatics systems.
• Provide oversight and leadership to the ODQ leadership team. Serve as a mentor, support professional growth, evaluate performance, and advocate for ODQ needs as appropriate. Encourage and promote diversity and inclusivity within ODQ and DF/HCC.
• Participate on various institutional and DF/HCC research committees as determined in consultation with DFCI and DF/HCC Leadership. Potential committee involvement includes the following:
  • Executive Committee for Consortium Clinical Research
  • Clinical Operations Committee and associated subcommittee working groups (Nursing, Pharmacy, Education)
  • Audit Committee
  • Data Safety Monitoring Committees
  • Data Safety Monitoring Board
  • Research Administrative Leadership Team
  • Research Informatics Committees related to iRIS/OnCore development, reporting and metrics, etc.
• 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 ODQ and other departments within DF/HCC and DF/HCC consortium members.
• Assist the DFCI and DF/HCC Leadership with related projects, as needed, such as Cancer Center Support Grant submissions and site visits, AAHRP submissions and site visits, media inquiries and other DF/HCC initiatives.
• Perform other duties as assigned.

SUPERVISORY RESPONSIBILITIES:

• The Director will have approximately 7 direct reports and approximately 26-30 indirect reports. 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
• 10 years of clinical trials experience required; oncology research preferred
• Experience in management, including supervisory and training experience, required

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.