Data Specialist, Lead

The Data Specialist, Lead provides advanced data management leadership for clinical trials and plays a key role in the operational oversight and development of Data Coordinators within the Clinical & Protocol Data Management (CPDM) Office at the Herbert Irving Comprehensive Cancer Center.

This role partners closely with Clinical Research Managers to ensure high-quality data practices, operational efficiency, and regulatory compliance across studies. The Data Specialist, Lead also supports staffing continuity, team performance, and cross-functional initiatives within assigned disease teams.

This position reports directly to the Assistant Director of Clinical Research Operations and is primarily based at 400 Kelby Street, Fort Lee, NJ. Hybrid work arrangements may be considered based on business needs.

Responsibilities

The Data Specialist, Lead is an experienced clinical research professional responsible for leading data management activities for complex clinical trials involving human subjects. This role builds upon Senior Data Coordinator responsibilities and includes leadership, mentorship, and operational oversight across the data coordination function.

Data Management & Quality Oversight

• Lead data management activities across the department’s clinical trials, ensuring accuracy, completeness, and timeliness of data entry and review.
• Oversee protocol review to ensure appropriate data capture, case report form alignment, and data flow processes.
• Ensure timely resolution of data queries, discrepancies, and data validation issues in collaboration with study teams and sponsors.
• Maintain compliance with GCP, FDA/HHS regulations and institutional policies.
• Partner with research teams to uphold data integrity, audit readiness and regulatory standards.
• Participate in sponsor, investigator, and internal study team meetings to represent data management functions.

Leadership & Team Oversight

• Assist Clinical Research Managers in the oversight of Data Coordinators, including workload distribution, performance monitoring, and quality assurance.
• Provide coverage for Data Coordinator vacancies to ensure continuity of study operations.
• Train, mentor, and onboard Data Coordinators, fostering professional development and adherence to best practices.
• Drive improvements in data entry timeliness, query resolution efficiency, and overall team performance.
• Serve as a subject matter expert and resource for complex data management issues.

Operations & Process Improvement

• Request EMR access for monitors and assists with troubleshooting: create CWID and link CWID to study in EPIC
• Receive monitoring visit requests and maintain schedule on the shared calendar.
• Oversee and support monitoring visits, ensuring all findings are appropriately tracked, escalated as needed and resolved in a timely and compliant manner.
• Prepare for and participate in sponsor and regulatory audits, ensuring audit readiness and timely follow up on findings including documentation and correct actions.
• Develop and implement tracking mechanisms and performance metrics to ensure timeliness, accuracy and completeness of data entry across studies.
• Assist the CPDM leadership in developing, implementing and executing departmental initiatives and cross-functional process focused on data quality, efficiency, and scalability.
• Participate in committees and working groups as a representative of data management.

Additional Responsibilities

• Perform all responsibilities of a Senior Data Coordinator for an assigned limited portfolio if needed, adjusted to accommodate leadership duties and departmental priorities.
• Contribute to special projects and departmental priorities.
• Perform other related duties and responsibilities as assigned/requested.

Do you have experience in macOS?, Do you have a Master’s degree?, * Bachelor’s degree plus three years related experience and/or equivalent in education and experience required., * Three years as a HICCC CPDM Data Coordinator, or 1 year of HICCC CPDM experience plus 2 years’ oncology clinical trials experience.

• Demonstrated strong performance.
• Excellent interpersonal, leadership, and organizational skills.
• Strong problem-solving and communication abilities.
• Proficiency in Microsoft Office (Word, Excel) and familiarity with Mac and PC platforms.
• Master’s degree in Management, Public Health, or related field.
• Prior experience in mentoring, training, or informal team leadership.
• Experience contributing to process improvement or operational initiatives.