Data Management Lead - VIR at NEXT Oncology – Fairfax, Virginia

Position Description: POSITION SUMMARY: Under the direction and supervision of the Director of Data Management, this position is responsible for guiding and managing all clinical data management activities according to quality standards, ICH guidelines, GCP and regulatory requirements. The person, reporting to the Director of CTM, is also responsible for managing the data management team to ensure the staffing and the operational aspects of the data management group are in line with the company requirements.

• Oversee and manage the data management department activities for all clinical trial studies.
• Represent the data management department in meetings with departments, clinical trial sponsors (or designees), and with external clients/vendors.
• Create thorough data quality checks and data review strategies to ensure the integrity of the clinical data.
• Aide in the recruitment and training of high performing data management staff to include medical records, monitor liaisons and data entry specialists.
• Meets with sponsor/monitors to review any concerns with the data management team and/or data entry.
• Meets with NEXT clinicians, managers, and other personnel as needed to assist data entry staff with query resolution.
• Responsible for ensuring that data entry remains current for all studies per SOP.
• Serves as a backup on studies to help with study coverage.
• Serves as a backup to provide support and information to monitors as necessary and as directed by supervisor(s).
• Responsible for reviewing and utilizing protocols for study related activities to assist the data management team.
• Complies with all applicable regulations, guidelines and procedures pertaining to data entry, data capture and clinical research.
• Communicates as needed with internal departments regarding data entry concerns.
• Attends required meetings as required.
• Performs other duties as assigned.

• Minimum of BS preferably in Health Sciences. MS preferred.
• Minimum 2-4 years in Clinical Data Management; 2-4 years prior management experience desired.
• Working knowledge of Phase I oncology clinical research, data entry, CRFs and electronic data capture (EDC) systems of a variety of platforms.
• Knowledge of appropriate software including Microsoft suite applications and Adobe Acrobat Pro.
• Excellent interpersonal skills to deal effectively with research personnel and staff.
• Knowledge of medical terminology.
• Knowledge of ICH GCP, FDA, OHRP, OSHA and HIPAA guidelines pertaining to clinical research.
• Excellent organizational skills to independently manage workflow.
• Ability to prioritize quickly and appropriately with minimal guidance.
• Ability to multi-task.
• Ability to work independently and function as part of a team.
• Clear and concise verbal and written communications.

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Full-time
• Exempt
• Monday to Friday
• 8am to 5pm