Manager, QARC Clinical Trial / Data Management - University of Massachusetts Medical School

POSITION SUMMARY:

The Quality Assurance Review Center (QARC) is a QA and data center within UMass Chan Medical School, Department of Radiation Oncology. QARC provides Radiation Therapy and Diagnostic Imaging services in support of cancer clinical trials.  QARC provides these services to the National Clinical Trials Network (NCTN) sponsored by the National Cancer Institute (NCI) as well as to several pharmaceutical companies sponsoring cancer clinical trials.

Under the Director of Operations, the Manager of QARC Clinical Trial / Data Management (CTM) is responsible for all operational aspects of the Division of Data Management.  This position is instrumental in the planning, implementation, and tracking of all clinical trial management and data operations. An individual in this role provides project and data management oversight and ensures daily operations are performed in accordance with organizational standards and Sponsor/NCTN Group obligations.

The CTM works closely with the Directors of Operations, Physics and Dosimetry, and Information Systems on strategic planning and establishing the direction and priorities for the organization while developing and maintaining key relationships with NCTN members and industry leaders.

ESSENTIAL FUNCTIONS:

• Provide overall direction to the division of data management, which may consist of project directors, study managers, research coordinators, and research assistants, for the development of study related materials such as clinical protocol, data management plans, radiation therapy quality assurance manuals, eCRFs, radiation therapy guidelines, etc.
• Perform day-to-day management and oversight of clinical trial data intake and processing.
• Reviewing monitoring reports, protocol deviations and data listings for studies to ensure reliable quality data are delivered and proactively identifies and solves issues/concerns.
• Oversee and track subject data and pro-actively identifies ways to prevent submission and reporting delays.
• Assist in the development of complex data collection databases and reports.
• Co-writing/maintaining SOPs and Working guidelines related to study management and data processing.
• Participate in staff, client, and senior management meetings related to study oversight, data management, database development, quality assurance and standards, audits, regulatory, and reporting requirements.
• Produce and present reports on assigned projects as well as standard program on a weekly and monthly basis.
• Ensure accuracy of reports by data review and resolving discrepancies internally for assigned projects/reports.
• Schedule, plan, coordinate, and review project activities. Provides periodic reports to management regarding status of projects.
• Ensures project work is planned, resource allocated and is successfully executed.
• Serve as subject matter expert, provide training, and ensure that priorities and procedures for data processing are followed by research personnel.
• Ensure new staff members are trained on Standard Operating Procedures and Working Guidelines in accordance with their job responsibilities.
• Actively works to continuously improve productivity and efficiency of study and data management operations.
• Ensuring that study documentation and files are maintained and up to date.
• Attends NCTN group meetings and industry sponsored investigator meetings as needed.
• Prepares and presents PowerPoint presentations for NCTN Group meetings and industry sponsored investigator meetings.
• Perform other duties as required.

REQUIRED QUALIFICATIONS:

• Bachelor’s Degree with 7+ years’ or a Master’s Degree with 5+ years’ experience in clinical operations or cancer clinical trial management.
• 3 years’ experience in supervision and training of staff.
• Knowledge of radiology, radiation oncology and/or oncology a plus
• Experience with tools, databases, and systems for managing clinical trials.
• Understanding of cancer clinical trials program (or operations) sponsored by industry and National Cancer Institute (NCI)
• Knowledge of ICH-GCP, FDA, and other health authorities’ regulations.
• Use teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed.
• Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.
• Excellent oral and written communication skills necessary to interact with clients and staff.
• Demonstrated experience in using computer-based tools including electronic mail, word processing. spreadsheet, and database products.

This position is located at the QARC data center in Lincoln, RI.  QARC provides radiation therapy and diagnostic imaging services to sponsors conducting cancer clinical trials.